A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors

Study Identifier:
GCT1042-01
CT.gov Identifier:
NCT03937024
EudraCT Identifier:
2018-003716-47
EU Trial (CTIS) Number:
2023-508526-10-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumor

To assess the safety, pharmacokinetics, pharmacodynamics and activity of GEN1042 administered as a monotherapy or in combination in subjects with metastatic or locally advanced solid tumors. The trial consists of 4 parts: a GEN1042 monotherapy dose escalation (phase 1a), a GEN1042 monotherapy expansion (phase 2a), a combination therapy safety run in (phase 1b), and a combination therapy expansion (phase 2b).

The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

To present preliminary data from the ongoing, first-in-human, open-label, phase 1/2 trial of DuoBody-CD40×4-1BB in advanced solid tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Respiratory and intrathoracic organs
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: Monotherapy - Dose Escalation and Dose Expansion Parts Biological: GEN1042
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Drug: Experimental: Combination Therapy - Safety Run-in and Expansion Parts Biological: GEN1042
Drug: Drug: Pembrolizumab
Drug: Drug: Cisplatin
Drug: Drug: Carboplatin
Drug: Drug: 5-FU
Drug: Drug: Gemcitabine
Drug: Drug: Nab paclitaxel
Drug: Drug: Pemetrexed
Drug: Drug: Paclitaxel
Drug: Patients received GEN1042 + PEM ± CTx (nab-paclitaxel + gemcitabine or cis/carboplatin + 5-FU) until disease progression or unacceptable toxicity.
Drug: ESMO IO 2023:
Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete

Requirements information
Inclusion criteria
  • Monotherapy - Dose Escalation and Dose Expansion Parts
  • Participants with non-CNS solid tumors that is metastatic or unresectable and for whom there is no available standard therapy.
  • Subjects with a confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC and for whom there is no available standard therapy
  • Combination Therapy - Dose Expansion Part
  • Participants with unresectable Stage III or Stage IV melanoma with no prior systemic anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal melanoma is excluded.
  • Subjects with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer therapy, no actionable mutation.
  • Subjects with recurrent or metastatic HNSCC with no prior systemic therapy administered in the recurrent or metastatic setting and tumor demonstrating PD-L1 IHC CPS ≥1.
  • Participants with confirmed metastatic PDAC with no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
  • General (all phases):
  • Must be age ≥ 18 years of age
  • Measurable disease according to RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Normal or adequate liver, renal, cardiac and bone marrow function
Exclusion criteria
  • Monotherapy - Dose Escalation and Dose Expansion Parts
  • Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration
  • Radiotherapy within 14 days prior to first GEN1042 administration
  • Toxicities from previous anti-cancer therapies that have not resolved
  • Combination Therapy - Dose Expansion Part
  • Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks or at least 5 half-lives of the drug (whichever is shorter) of the first dose of trial treatment.
  • Radiotherapy within 14 days of start of trial treatment or received lung radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment.
  • General (all phases)
  • Participants has an active, known, or suspected autoimmune disease.
  • History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
  • History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
  • Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Barcelona
Barcelona, Spain, 08023
Investigator
Tatiana Hernandez
Status
Recruiting
Condition(s) Treated at Site
Respiratory and intrathoracic organs
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Juan José Soto
Status
Recruiting
Condition(s) Treated at Site
Respiratory and intrathoracic organs
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno
Status
Recruitment Complete
Condition(s) Treated at Site
Respiratory and intrathoracic organs