Clinical trial • Phase I • Oncology

LIVMONIPLIMAB for Locally advanced or metastatic solid tumors | Solid tumors

Phase I trial of LIVMONIPLIMAB for Locally advanced or metastatic solid tumors | Solid tumors. open-label, adaptive. 210 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Locally advanced or metastatic solid tumors | Solid tumors
Trial Stage
Phase I
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
18-12-2023
First CTIS Authorization Date
05-03-2024

Trial design

open-label, adaptive Phase I trial in Germany, Italy, Poland and others.

Open Label
Yes
Adaptive
True, dose-escalation design to determine the RP2D (recommended phase 2 dose) with dose-escalation cohorts followed by dose-expansion cohorts; escalation decisions guided by safety, tolerability and PK/ADA data.
Biomarker Stratified
True, biomarker: microsatellite stability (MSS) / mismatch repair proficient status for MSS-CRC cohorts (determined by PCR/NGS or IHC)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
210

Eligibility

Recruits 210 adults.

Inclusion criteria

  • {"criterion_text":"- For Dose Escalation only: Subjects with an advanced solid tumor who are considered refractory to or intolerant of all existing therapy(ies) known to provide a clinical benefit for their condition. Additionally, subjects who have been offered standard therapies and refused, or who are considered ineligible for standard therapies, may be eligible for this study on a case-by-case basis, after discussion with and agreement from the sponsor.\n- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n- For Dose Expansion only: Subjects must have measurable disease per RECIST1.1\n- For Dose Expansion only: All subjects with MSS-CRC, HCC, or pancreatic adenocarcinoma must not have had prior treatment with a PD-1/PDL-1 antagonist in any line of therapy\n- Subject has adequate bone marrow, renal, hepatic, and coagulation function.\n- For Dose Escalation only: Subjects with pancreatic adenocarcinoma, urothelial cancer, Hepatocellular carcinoma (HCC), or Head and neck squamous cell carcinoma (HNSCC) who are being considered for the dose escalation cohorts must also meet the histology specific eligibility criteria described below for dose expansion.\n- For Dose Expansion only subjects must meet criteria specific to the type of cancer: Pancreatic adenocarcinoma and have disease progression during or after 1 systemic therapy (including gemcitabine monotherapy or in combination with other agents, FOLFIRINOX [or another regimen including both 5-fluorouracil and oxaliplatin], capecitabine monotherapy or in combination with other agents) administered in the adjuvant, locally advanced, or metastatic setting. Progression on more than 1 prior systemic therapy is not allowed in this cohort. If the therapy was used in an adjuvant setting, disease progression must have occurred within 6 months of completing adjuvant therapy.\n- For Dose Expansion only subjects must meet criteria specific to the type of cancer: Urothelial cancer of the bladder and urinary tract and must have progressed following treatment with a platinum-based regimen (administered in any line of therapy) and a programmed death 1/programmed death ligand 1 (PD1/PDL1) antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).\n- For Dose Expansion only subjects must meet criteria specific to the type of cancer: HCC and must have disease progression during or after 1 prior line of systemic therapy. Progression on more than 1 prior systemic therapy is not allowed in this cohort.\n- For Dose Expansion only subjects must meet criteria specific to the type of cancer: HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have progressed following treatment with platinum-based regimen (administered in any line of therapy) and a PD1/PDL1 antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or antiPDL1 therapy).\n- For Dose Expansion only subjects must meet criteria specific to the type of cancer: MSS-CRC subjects with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma (as determined by PCR/NGS or IHC, respectively) who have received prior fluorouracil-based combination chemotherapy regimens including oxaliplatin and irinotecan (with or without VEGF and/or EGFR targeted agents).\n- Subjects with progression on or after more than 2 prior systemic therapies in the metastatic setting will not be eligible for this cohort - NSCLC subjects with histologically or cytologically confirmed advanced or metastatic NSCLC who have received 1 prior line of chemotherapy and 1 prior anti-PD- (L)1 antibody, administered either concurrently or sequentially in the metastatic setting. Subjects who have progressed on more than 1 line of chemotherapy in the metastatic setting and/or prior anti-PD (L)1 in the metastatic setting and with known EGFR mutations or ALK gene rearrangements will not be eligible."}

Exclusion criteria

  • {"criterion_text":"- Has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 5 half-lives or 28 days (whichever is shorter), prior to the first dose of the study drug.\n- Subject has unresolved AEs > Grade 1 from prior anticancer therapy except for alopecia.\n- Has a history of primary immunodeficiency, bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis.\n- Has a known uncontrolled metastases to the central nervous system (with certain exceptions).\n- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of the study drug."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Dose Escalation Phase: The determination of the RP2D of ABBV-151 as monotherapy and in combination with budigalimab\n- Dose Expansion Phase: Objective Response Rate of CR or PR","definition_or_measurement_approach":"Dose Escalation Phase: determination of the recommended phase 2 dose (RP2D) of ABBV-151 via dose-escalation cohorts. Dose Expansion Phase: Objective response rate (complete response [CR] or partial response [PR]) measured per RECIST v1.1."}

Secondary endpoints

  • {"endpoint_text":"- Dose Escalation Phase: Assessment of AEs, serious AEs (SAEs), laboratory parameters, vital signs, electrocardiogram (ECG) results, PK measurements, and antidrug antibody (ADA) measurements.\n- Dose Expansion Phase: Duration of response (DOR)\n- Dose Expansion Phase: Progression-free survival (PFS)\n- Dose Expansion Phase: Assessment of AEs, SAEs, laboratory parameters, vital signs, ECG results, PK, and ADA measurements","definition_or_measurement_approach":"Safety and tolerability endpoints: assessment of adverse events (AEs)/serious AEs, laboratory parameters, vital signs, ECGs. PK and immunogenicity: pharmacokinetic measurements and antidrug antibody (ADA) measurements. Efficacy endpoints in expansion: duration of response (DOR) and progression-free survival (PFS) as standard oncology measures (DOR and PFS typically per RECIST v1.1 assessment schedule)."}

Recruitment

Planned Sample Size
210
Recruitment Window Months
49
Consent Approach
Subject information and informed consent forms are provided (documents listed) in multiple languages including German, Italian, Polish, French, English, Spanish, and Dutch. No explicit details on assent or age-specific consent handling are provided in the record.

Geography

Total Number Of Sites
19
Total Number Of Participants
120

Germany

Earliest CTIS Part Ii Submission Date
02-12-2024
Latest Decision Or Authorization Date
20-06-2025
Processing Time Days
200
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Gynaekologie & Gynaekologische Onkologie
Contact Person Name
Philipp Harter
Contact Person Email
studiengo@kem-med.com

Italy

Earliest CTIS Part Ii Submission Date
11-12-2024
Latest Decision Or Authorization Date
17-06-2025
Processing Time Days
188
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Person Name
Vanda Salutari
Site Name
Istituto Europeo Di Oncologia S.r.l.
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Contact Person Name
Adriano Gravina
Contact Person Email
a.gravina@istitutotumori.na.it

Poland

Earliest CTIS Part Ii Submission Date
11-12-2024
Latest Decision Or Authorization Date
23-06-2025
Processing Time Days
194
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oddzial Badan Wczesnych Faz
Contact Person Name
Iwona Lugowska
Contact Person Email
obwf@coi.pl
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Jagiellońskie Centrum Innowacji Sp. z o.o.
Department Name
Centrum Badan Klinicznych JCI
Contact Person Name
Pawel Blecharz
Contact Person Email
pawel.blecharz@interia.pl

Belgium

Earliest CTIS Part Ii Submission Date
08-03-2024
Latest Decision Or Authorization Date
17-06-2025
Processing Time Days
466
Number Of Sites
1
Number Of Participants
26

Sites

Site Name
Cliniques Universitaires Saint-Luc
Contact Person Name
Jean-Pascal Machiels

France

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
632
Number Of Sites
4
Number Of Participants
28

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Oncologie Médicale
Contact Person Name
Carlos GOMEZ-ROCA
Site Name
Institut Gustave Roussy
Department Name
Département d'Innovation Thérapeutique et Essais Précoces (DITEP)
Contact Person Name
Antoine HOLLEBECQUE
Site Name
Centre Jean Perrin
Department Name
Oncologie Médicale
Contact Person Name
Marie-Ange MOURET-REYNIER
Site Name
Centre Leon Berard
Department Name
Cancérologie Médicale
Contact Person Name
Philippe CASSIER

Spain

Earliest CTIS Part Ii Submission Date
05-03-2024
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
694
Number Of Sites
7
Number Of Participants
26

Sites

Site Name
Vall D Hebron Institute Of Oncology
Department Name
Vall d’Hebron Institute of Oncology (VHIO)
Contact Person Name
Roberta Mazzeo
Contact Person Email
robertamazzeo@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Unidad de Ensayos Clinicos
Contact Person Name
Eduardo Castañon Alvarez
Contact Person Email
ecastanon@unav.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematología y Oncología
Contact Person Name
Desamparados Roda Perez
Contact Person Email
droda@incliva.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
START Madrid-FJD
Contact Person Name
Vitor Moreno García
Contact Person Email
victor.moreno@startmadrid.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
START Madrid-CIOCC (Unidad de Ensayos Fase 1)
Contact Person Name
Yarza Barrio Ramon
Contact Person Email
ramon.yarza@startmadrid.com
Site Name
Clinica Universidad De Navarra (Madrid site)
Department Name
Unidad de Ensayos Clinicos
Contact Person Name
Eduardo Castañon Alvarez
Contact Person Email
ecastanon@unav.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Oncologia
Contact Person Name
Pablo Gajate Borau
Contact Person Email
pgajateborau@gmail.com

Sponsor

Primary sponsor

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

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Kit generation, sample collection and reconciliation","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Abbvie Inc.","duties_or_roles":"Biomarker Sampling","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"AbbVie Deutschland GmbH & Co. KG","duties_or_roles":"Analysis of PK/ADA/nAb","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Livmoniplimab
Active Substance
LIVMONIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
First In Human
Yes
Investigational Product Name
Budigalimab
Active Substance
BUDIGALIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Combination Treatment
Yes

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