Clinical trial • Phase I • Oncology

IMGN151 for Endometrial cancer (recurrent) | Epithelial ovarian cancer (recurrent) | Fallopian tube cancer | Primary peritoneal cancer | Cervical cancer (recurrent)

Phase I trial of IMGN151 for Endometrial cancer (recurrent) | Epithelial ovarian cancer (recurrent) | Fallopian tube cancer | Primary peritoneal cancer |…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Endometrial cancer (recurrent) | Epithelial ovarian cancer (recurrent) | Fallopian tube cancer | Primary peritoneal cancer | Cervical cancer (recurrent)
Trial Stage
Phase I
Drug Modality
ADC

Key dates

Initial CTIS Submission Date
19-04-2024
First CTIS Authorization Date
12-08-2024

Trial design

Randomised, open-label, adaptive Phase I trial across 34 sites in Netherlands, Italy, Ireland and others.

Randomised
Yes
Open Label
Yes
Adaptive
True - Dose-escalation uses a 3+3 design to identify DLTs, MTD or MAD and inform dose selection; expansion and dose-optimization cohorts follow dose-escalation outcomes; Dose Optimization includes randomized 1:1:1 allocation across 3 expanded dose levels.
Biomarker Stratified
True - Biomarker: folate receptor alpha (FRα) IHC status; cohorts include subjects with prior FRα-directed therapy (Cohort C) versus cohorts excluding prior FRα-directed therapy (Cohorts A, B, D, E).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
234

Eligibility

Recruits 234 Vulnerable population selected. Consent must be provided by the subject or their legally authorised representative(s): "Subjects or their legally authorized representative(s) must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements." Study-specific ICFs and subject information documents (including pregnant-participant ICFs) are provided per country. No paediatric assent procedures are specified (subjects must be ≥18 years)..

Pregnancy Exclusion
Subjects who are pregnant or breastfeeding.
Vulnerable Population
Vulnerable population selected. Consent must be provided by the subject or their legally authorised representative(s): "Subjects or their legally authorized representative(s) must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements." Study-specific ICFs and subject information documents (including pregnant-participant ICFs) are provided per country. No paediatric assent procedures are specified (subjects must be ≥18 years).

Inclusion criteria

  • {"criterion_text":"- Subjects ≥ 18 years of age.\n- Completed prior therapy within the specified times below: a. Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) before planned first dose of IMGN151. b. Focal radiation completed at least 2 weeks before planned first dose of IMGN151.\n- Stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia or hemoglobin within 10 days before C1D1).\n- Completed any major surgery at least 4 weeks before first dose of IMGN151 and have recovered or stabilized from the side effects of prior surgery before first dose of IMGN151.\n- Adequate hematologic, liver, and kidney functions defined as follows: a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/μL) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell growth factors in the 20 days before C1D1 b. Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the 10 days before C1D1 c. Hemoglobin ≥ 9.0 g/dL without packed red blood cell transfusion in the 10 days before C1D1 d. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 as calculated by Cockcroft-gault or CKD-EPI (Appendix G), or an estimated creatinine clearance of ≥ 60 mL/min e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN) f. Bilirubin ≤ 1.5 × ULN (subjects with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 × ULN) g. Albumin ≥ 2 g/dL\n- Subjects or their legally authorized representative(s) must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.\n- Females of childbearing potential (FOCBP) must agree to use highly effective contraceptive method(s) while on IMGN151 and for at least 28 weeks after the last dose.\n- For FOCBP, a negative serum pregnancy test at Screening and a negative serum or urine pregnancy test within 72 hours before first dose of IMGN151 is required.\n- An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n- Dose-Escalation Phase: A confirmed diagnosis of recurrent endometrial cancer (endometrioid or serous histology only) or high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC). Subjects will have exhausted appropriate standard-of-care therapy and be appropriate for participation in a single-agent Phase 1 study in the opinion of the investigator.\n- If performed previously, results of germline and/or somatic BRCA testing must be reported at study entry. Subjects with PROC with tumors harboring a BRCA mutation are required to have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor if available locally and medically appropriate. Note that BRCA testing is not required for enrollment for subjects who have not had it done previously.\n- Dose Optimization: a. A confirmed diagnosis of platinum-resistant, high-grade serous EOC (PROC) with no previous FRα-directed therapy. Subjects with PROC will have had no more than 5 prior lines of therapy, with no more than 2 prior therapies since development of platinum resistance. Platinum-resistant disease is defined as radiographic progression within 6 months (up to 182 days) after the last dose of the most recent platinum therapy. Note: Subjects will have received appropriate prior standard of care therapy for PROC, as applicable and locally available in the opinion of the investigator. Note: Progression is calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.\n- Expansion Phase: a. For Cohort A, a confirmed diagnosis of recurrent endometrial cancer (high-grade endometrioid or serous histology only). Subjects with endometrial cancer will have had 1-3 prior lines of therapy. b. For Cohort B, a confirmed diagnosis of PROC with no previous FRα-directed therapy. Subjects with PROC will have had no more than 5 prior lines of therapy, with no more than 2 prior therapies since development of platinum resistance. Platinum-resistant disease is defined as radiographic progression within 6 months (up to 182 days) after the last dose of the most recent platinum therapy. Note: Subjects will have received appropriate prior standard of care therapy for PROC, as applicable and locally available in the opinion of the investigator. c. For Cohort C, a confirmed diagnosis of PROC with previous FRα-directed therapy. Subjects will have had at least one intervening anticancer therapy between prior FRα-directed therapy and IMGN151. Note: Subjects will have received appropriate prior standard of care therapy for PROC, as applicable and locally available in the opinion of the investigator. d. For Cohort D, a confirmed diagnosis of non-high-grade serous EOC including the following histologies: carcinosarcoma, endometrioid, and low-grade serous carcinoma. Mixed histologies of these listed histologies only are acceptable. Borderline tumors are excluded. Subjects will have exhausted appropriate standard-of-care therapy and, in the opinion of the investigator, be appropriate for participation in a single-agent Phase 1 study e. For Cohort E, a confirmed diagnosis of cervical cancer including the following histologies: squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma. Subjects with cervical cancer will have had 1-4 prior lines of therapy. Subjects will have exhausted appropriate standard-of-care therapy and, in the opinion of the investigator, be appropriate for participation in a single-agent Phase 1 study. f. For subjects with cervical cancer with Combined Positive Score (CPS) > 1 or with endometrial cancer, prior checkpoint inhibitor therapy, alone or in combination, is required if available locally and medically appropriate.\n- Prior anticancer therapy a. Neoadjuvant and adjuvant therapies are considered 1 line of therapy. b. Maintenance therapy (eg, bevacizumab or PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently). c. Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently). d. Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance. e. For Cohort C: Prior FRα-targeting therapy and at least 1 intervening therapy prior to IMGN151 treatment are required. f. For Cohorts A and E: Radio-sensitizing chemotherapy, if only given with radiation therapy, is not considered a line of therapy.\n- Evaluable lesions a. Dose-Escalation Phase: Both radiologically evaluable and nonevaluable disease is acceptable. b. Dose Optimization and Expansion Phase: Subjects must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).\n- An archival tumor tissue block or slides, or a procedure to obtain a new biopsy using a low-risk, medically routine procedure for retrospective IHC confirmation of FRα status is required. a. Expansion Phase: For subjects with ovarian cancer enrolled in the prior FRα-targeting agent exposure cohort (Cohort C), in addition to providing an archival tissue from prior to receipt of prior FRα-targeting agent, subjects are required to provide a second tumor tissue sample after completion of prior FRα-targeting therapy and before the start of IMGN151 treatment."}

Exclusion criteria

  • {"criterion_text":"- Subjects with ovarian cancer with histologies including clear cell, mucinous, or borderline ovarian tumor. a. With the exception of subjects enrolled in Cohort D, subjects with ovarian cancer with histologies including endometrioid, sarcomatous histology, mixed tumors containing any of the above histologies, as well as low-grade serous carcinoma. b. For Cohort A, subjects with endometrial cancer with histologies other than high-grade serous or high-grade endometrioid. c. For Cohort E, subjects with cervical cancer with histologies other than adenocarcinoma, squamous cell carcinoma, and adenosquamous carcinoma.\n- History of cirrhotic liver disease (Child-Pugh Class B or C).\n- Evidence of pneumonitis on baseline imaging or subjects with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis.\n- Prior hypersensitivity to monoclonal antibodies (mAb).\n- Subjects who are pregnant or breastfeeding.\n- For Dose Optimization and Expansion Phase: Receipt of a prior FRα-targeting agent, with the exception of subjects enrolled in the prior FRα-targeting agent, ovarian cancer cohort (Cohort C).\n- Untreated or symptomatic central nervous system metastases Note: Subjects requiring ongoing steroids for central nervous system metastases are not eligible for enrollment.\n- History of other malignancy within 3 years before enrollment Note: Subjects with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.\n- Prior known hypersensitivity reactions to study drugs and/or any of their\n- For Cohort B and Dose Optimization: subjects with primary platinum refractory ovarian cancer, defined as disease progression on or within 3 months of completion of first platinum-based treatment.\n- Radiation therapy of > 20% of the potential bone marrow Note: For subjects with endometrial or cervical cancer: Whole pelvic radiation therapy (WPXRT) given in the upfront/adjuvant setting, ± brachytherapy, is permitted.\n- > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE v5.0).\n- Subjects with the following ocular history and/or concurrent disorders: a. Active or chronic corneal epithelial disorders other than non-confluent superficial keratopathy/keratitis, including confluent superficial punctate keratopathy/keratitis (SPK) not expected to resolve to non-confluence or better within the screening window with SOC intervention b. History of corneal transplantation c. Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery d. Active or chronic clinically significant (≥ Grade 3) corneal disorders (e.g., Fuch’s dystrophy or neurotrophic keratitis) e. Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema or an ocular condition with high risk of retinal detachment f. Monocular vision with visual acuity in the worse-seeing eye (worse than 20/200 or visual fields less than 20 degrees).\n- Serious concurrent illness or clinically relevant active infection, including, but not limited to, the following: a. Active hepatitis B or C infection (whether or not on active antiviral therapy). b. HIV infection in subjects with CD4+ T-cell (CD4+) counts < 350 cells/µL. c. Active cytomegalovirus infection. d. Active COVID-19/SARS-CoV-2 infection. Although SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines and standards. e. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before first dose of IMGN151. Note: Testing at Screening is not required for the above infections unless clinically indicated.\n- History of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome).\n- Clinically significant cardiac disease including, but not limited to, any of the following: a. Myocardial infarction ≤ 6 months before first dose b. Unstable angina pectoris c. Uncontrolled congestive heart failure (New York Heart Association > class II) d. Uncontrolled ≥ Grade 3 hypertension (per CTCAE v5.0) e. Uncontrolled cardiac arrhythmias f. QTc interval > 470 ms\n- History of hemorrhagic or ischemic stroke within 6 months before enrollment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Co-Primary Endpoints:\tIncidence of adverse events (AEs), serious adverse events (SAEs), and DLTs; Determine the recommended dose of IMGN151 monotherapy","definition_or_measurement_approach":"Incidence of AEs, SAEs and DLTs will be recorded and used to assess safety and tolerability; dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), or maximum administered dose (MAD) will be assessed during dose-escalation to determine the recommended dose of IMGN151 monotherapy."}

Secondary endpoints

  • {"endpoint_text":"- Summary PK parameters and treatment-emergent anti-drug antibodies (ADAs)","definition_or_measurement_approach":"Pharmacokinetic parameters will be summarised; treatment-emergent anti-drug antibodies (ADAs) will be measured to assess immunogenicity."}
  • {"endpoint_text":"- ORR (which includes best response of complete response [CR] or partial response [PR] as assessed by the investigator) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria","definition_or_measurement_approach":"Objective response rate (ORR) per investigator assessment using RECIST v1.1 (CR or PR)."}
  • {"endpoint_text":"- DOR (defined as the time from initial response [CR or PR] until radiological progressive disease [PD], as assessed by the investigator, or death, whichever occurs first) per RECIST v1.1 criteria","definition_or_measurement_approach":"Duration of response measured from first documented CR or PR to radiologic progression (PD) per RECIST v1.1 or death, whichever occurs first."}

Recruitment

Planned Sample Size
234
Recruitment Window Months
48
Consent Approach
Informed consent is required from each subject or their legally authorized representative(s): "Subjects or their legally authorized representative(s) must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements." Study-specific ICFs and subject information documents are provided per country (documents listed for DE, FR, IT, NL, ES, IE), and there are dedicated ICF versions for pregnant participants; no paediatric/assent documentation is provided because enrollment is restricted to ≥18 years.

Geography

Total Number Of Sites
34
Total Number Of Participants
169

Netherlands

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
15-08-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Department of Internal Oncology
Contact Person Name
Ingrid Boere
Contact Person Email
i.boere@erasmusmc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Department of Medical Oncology
Contact Person Name
Mathilde Jalving
Contact Person Email
m.jalving@umcg.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medical oncology
Contact Person Name
Eelke Hiddo Gort
Contact Person Email
oncosutudies@umcutrecht.nl

Italy

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
13-08-2024
Processing Time Days
25
Number Of Sites
5
Number Of Participants
55

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Ginecologia Oncologia
Contact Person Name
Vanda Salutari
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Unità Operativa di Ginecologia Oncologica
Contact Person Name
Annalisa Fontana
Contact Person Email
fontana.annalisa@aou.mo.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Department of Medical Oncology
Contact Person Name
Rossana Berardi
Site Name
Humanitas Mirasole S.p.A.
Department Name
Ginecologia oncologica medica - ricerca
Contact Person Name
Domenica Lorusso
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Sperimentazioni Cliniche
Contact Person Name
Adriano Gravina
Contact Person Email
a.gravina@istitutotumori.na.it

Ireland

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
16-08-2024
Processing Time Days
11
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
University Hospital Galway
Department Name
Medical Oncology Department
Contact Person Name
Michael McCarthy
Contact Person Email
Michael.McCarthy7@hse.ie
Site Name
Mater Misericordiae University Hospital
Department Name
START Dublin
Contact Person Name
Austin Duffy
Contact Person Email
austin.duffy@startdublin.com

Germany

Earliest CTIS Part Ii Submission Date
10-07-2024
Latest Decision Or Authorization Date
16-08-2024
Processing Time Days
37
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Department Name
Oncology
Contact Person Name
Michael Eichbaum
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department for Gynecology, Campus Virchow Klinikum
Contact Person Name
Elena Ioana Braicu
Contact Person Email
Elena.braicu@charite.de
Site Name
Universitat Heidelberg
Department Name
Obstetrics and Gynecology
Contact Person Name
Frederik Marme
Contact Person Email
frederik.marme@umm.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Gynecologic oncology
Contact Person Name
Philipp Harter
Contact Person Email
p.harter@kem-med.com

France

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
33
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Centre Antoine Lacassagne
Department Name
Oncology
Contact Person Name
Philippe Follana
Site Name
Institut Gustave Roussy
Department Name
Oncology
Contact Person Name
Alexandra Leary
Site Name
Centre Leon Berard
Department Name
Oncology
Contact Person Name
Isabelle Ray-Coquard
Site Name
Hospices Civils De Lyon
Department Name
Oncology
Contact Person Name
Benoit You
Contact Person Email
benoit.you@chu-lyon.fr
Site Name
Institut Bergonie
Department Name
Oncology
Contact Person Name
Antoine Italiano
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Oncology
Contact Person Name
Antoine Angelergues
Contact Person Email
aangelergues@hopital-dcss.org
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncology
Contact Person Name
Michel Fabbro
Contact Person Email
Michel.Fabbro@icm.unucancer.fr
Site Name
Institut de Cancerologie de l Ouest
Department Name
Oncology
Contact Person Name
Dominique Berton

Spain

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
12-08-2024
Processing Time Days
73
Number Of Sites
8
Number Of Participants
35

Sites

Site Name
Hospital Son Llatzer
Department Name
Medical Oncology
Contact Person Name
Ester Gost
Contact Person Email
ester.gost@hsll.es
Site Name
Hospital Universitario Reina Sofia
Department Name
Medical Oncology
Contact Person Name
Maria Jesús Rubio Pérez
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Department Name
Medical Oncology
Contact Person Name
Andres Redondo
Contact Person Email
aredondo12@gmail.com
Site Name
MD Anderson Cancer Center
Department Name
Medical Oncology
Contact Person Name
Raul Marquez Vazquez
Contact Person Email
raulmarquez@mdanderson.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Ana Oaknin
Contact Person Email
aoaknin@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Contact Person Name
Eva Maria Guerra Alia
Contact Person Email
eva_m_guerra@hotmail.com
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Pau Guillén Sentís
Contact Person Email
pguillens@iconcologia.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Contact Person Name
Jose Alejandro Perez-Fidalgo
Contact Person Email
japfidalgo@msn.com

Belgium

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
13-08-2024
Processing Time Days
27
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
UZ Leuven
Department Name
Gynaecological Oncology
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Hannelore Denys
Contact Person Email
Hannelore.denys@uzgent.be
Site Name
Hopital De Libramont
Department Name
Medical Oncology
Contact Person Name
Frederic Forget
Contact Person Email
Frederic.forget@vivalia.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
Jean-Francois Baurain

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
PPD Development L.P.
Responsibilities
sponsorDuties codes: [4]; contact: channy.chhay@ppd.com
Name
Ergomed Clinical Research Limited
Responsibilities
sponsorDuties codes: [1,12,2,5,6]; contact: Helene.VelasquezGiron@ergomedgroup.com
Name
4g Clinical LLC
Responsibilities
sponsorDuties codes: [3]; contact: giac@4gclinical.com
Name
Almac
Responsibilities
IP shipment, IVRS, IP labelling; contact: katlin.hickson@almacgroup.co
Name
Icon Laboratory Services Inc.
Responsibilities
laboratory/testing services (sponsorDuties codes: [4]); contact: christopher.chong@iconplc.com

Third parties

  • {"country":"United States","full_name":"PPD Development L.P.","duties_or_roles":"sponsorDuties codes: [4]; contact email: channy.chhay@ppd.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6]; contact email: safoora.AKRAM@3ds.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Ergomed Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,12,2,5,6]; contact email: Helene.VelasquezGiron@ergomedgroup.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: [3]; contact email: giac@4gclinical.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email: catherine.mcnally@roche.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email: christopher.chong@iconplc.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac","duties_or_roles":"sponsorDuties: IP shipment, IVRS, IP labelling; contact email: katlin.hickson@almacgroup.co","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
IMGN151
Active Substance
IMGN151
Modality
ADC
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Investigational (prodAuthStatus 1)
First In Human
Yes

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