DS-3939A for Metastatic solid tumor|Advanced solid tumor

Inclusion criteria

• {"criterion_text":"- Sign and date the main Informed Consent Form (ICF)."}
• {"criterion_text":"- Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment."}
• {"criterion_text":"- Has adequate organ function."}
• {"criterion_text":"- Measurable disease based on RECIST V1.1."}
• {"criterion_text":"- Eastern Cooperative Oncology Group performance status score of 0 or 1."}
• {"criterion_text":"- Additional inclusion criteria for Part 1: Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignat tumors."}
• {"criterion_text":"- Additional inclusion criteria for Part 2: Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy."}
• {"criterion_text":"- Additional inclusion criteria for Part 2: Is able to provide either of the following baseline tumor samples: a. Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Screening Period, or o Fresh core needle biopsy sample o Biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy b. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample."}

Exclusion criteria

• {"criterion_text":"- Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1."}
• {"criterion_text":"- Has spinal cord compression or clinically active CNS metastases."}
• {"criterion_text":"- Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years."}
• {"criterion_text":"- Has a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening."}
• {"criterion_text":"- Has active or uncontrolled human immunodeficiency virus (HIV) infection."}
• {"criterion_text":"- Has active or uncontrolled hepatitis B virus or hepatitis C virus infection."}
• {"criterion_text":"- Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event."}
• {"criterion_text":"- Has an active, known, or suspected autoimmune disease."}
• {"criterion_text":"- Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment."}

Primary endpoints

• {"endpoint_text":"- Dose-limiting Toxicities (DLTs) [Part 1 only], Treatmentemergent Adverse Events (TEAEs), Laboratory findings, electrocardiogram (ECG), vital signs, echocardiogram or multigated acquisition (ECHO/MUGA) findings, physical examination results","definition_or_measurement_approach":"Safety and tolerability events (DLTs, TEAEs) assessed via clinical AE reporting, laboratory tests, ECG, vital signs, ECHO/MUGA and physical examinations during Part 1 (dose escalation)."}
• {"endpoint_text":"- Objective Response Rate (ORR) [Part 2 only]","definition_or_measurement_approach":"ORR assessed per RECIST v1.1 (measurable disease required per inclusion criteria); Part 2 evaluates ORR at the Recommended Dose for Expansion (RDE)."}

Secondary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR) [Part 1 only]","definition_or_measurement_approach":"ORR assessed per RECIST v1.1 in Part 1 dose-escalation cohort."}
• {"endpoint_text":"- Disease Control Rate (DCR)","definition_or_measurement_approach":"DCR assessed per RECIST v1.1 (protocol-defined timepoints)."}
• {"endpoint_text":"- Duration of Response (DoR)","definition_or_measurement_approach":"DoR determined by independent central review with masking (as stated in translations)."}
• {"endpoint_text":"- Time to Response (TTR)","definition_or_measurement_approach":"TTR measured as time from first dose to first documented response per RECIST v1.1."}
• {"endpoint_text":"- Progression Free Survival (PFS)","definition_or_measurement_approach":"PFS measured per RECIST v1.1 from first dose to documented progression or death."}
• {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"OS measured from first dose to death from any cause."}
• {"endpoint_text":"- TA-MUC1 Expression by Immunohistochemistry (IHC)","definition_or_measurement_approach":"Tumor TA-MUC1 expression assessed by IHC on tumor tissue (protocol-defined assay and scoring)."}
• {"endpoint_text":"- Plasma PK parameters (eg, AUClast, AUCtau, Cmax, Tmax, Ctrough, and t1/2) of total conjugated payload, total anti-TAMUC1 antibody, and free payload","definition_or_measurement_approach":"PK parameters measured in plasma for total conjugated payload, total anti-TA-MUC1 antibody, and free payload (specified PK metrics: AUClast, AUCtau, Cmax, Tmax, Ctrough, t1/2)."}
• {"endpoint_text":"- Anti-drug Antibodies (ADAs) for DS-3939a (status and titers) at Baseline and on treatment","definition_or_measurement_approach":"ADA status and titers assessed at baseline and during treatment using immunogenicity assays."}

Methods

• Investigator/site-led recruitment using Dr-to-Patient letters (K2 Dr-to-Patient Letter documents present) delivered via treating physicians at participating hospitals/sites.
• Patient-facing brochures (K2 Patient Brochure documents) provided at sites to inform potential participants.
• Formal recruit and consent procedures documented (K1_Recruitment Arrangements, 'Recruit and consent procedure' document) indicating site-based recruitment workflow.

Belgium

Earliest CTIS Part Ii Submission Date

26-09-2024

Latest Decision Or Authorization Date

11-10-2024

Processing Time Days

15

Number Of Sites

1

Number Of Participants

17

Spain

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

15-10-2024

Processing Time Days

14

Number Of Sites

8

Number Of Participants

95

France

Earliest CTIS Part Ii Submission Date

19-08-2024

Latest Decision Or Authorization Date

11-10-2024

Processing Time Days

53

Number Of Sites

8

Number Of Participants

95

Primary sponsor

Full Name

Daiichi Sankyo Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Laboratories

Responsibilities

Laboratory services; sponsorDuties code: [4]; contact email: q2_eu_clinical_trials_information@q2labsolutions.com

Name

Pharmaceutical Product Development LLC

Responsibilities

Operational/CRO functions; sponsorDuties code: [4]; contact email: daiichiminiteam@ppd.com

Name

IQVIA Limited

Responsibilities

Operational CRO roles including monitoring, data management and other services (sponsorDuties codes: [1,10,11,12,13,2,5,6]); contact email: eu_clinical_trials_information@iqvia.com

Name

Bioclinica Inc.

Responsibilities

Central Imaging Scan Collection, ILDAC management

Name

Suvoda LLC

Responsibilities

eClinical/quality assurance functions (sponsorDuties code: [3])

Name

CellCarta

Responsibilities

Laboratory/sample processing roles (sponsorDuties code: [4])

Name

WCG Clinical Inc.

Responsibilities

Safety Vigilance

Name

Azenta US Inc.

Responsibilities

Long-term sample storage

Name

Guardant Health Inc.

Responsibilities

Biomarker/genomic testing support (sponsorDuties code: [4])

Name

Ventana Medical Systems Inc.

Responsibilities

Laboratory/assay support (sponsorDuties code: [4])

Name

Daiichi Sankyo Co. Ltd.

Responsibilities

Biomarker testing and laboratory support

Third parties

• {"country":"United States","full_name":"IQVIA Laboratories","duties_or_roles":"sponsorDuties codes: [4]; contact email: q2_eu_clinical_trials_information@q2labsolutions.com","organisation_type":"Industry"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]; contact email: daiichiminiteam@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1,10,11,12,13,2,5,6]; responsibilities include a range of operational roles (as per sponsorDuties entries); contact email: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging Scan Collection, ILDAC management","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: [3]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties code: [4]; contact email: roche.cdx_cap_clia_lab@roche.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"long-term sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"Japan","full_name":"Daiichi Sankyo Co. Ltd.","duties_or_roles":"Biomarker testing; additional sponsor duties code: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties code: [4]; contact email: biopharma_samples@guardanthealth.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties code: [4]; contact email: GRP-P2944@groups.cellcarta.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Safety Vigilance","organisation_type":"Pharmaceutical company"}