GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors

  • STATUS
    Recruiting
  • End date
    Sep 20, 2025
  • participants needed
    447
  • sponsor
    Genmab
Updated on 20 July 2022
metastatic melanoma
paclitaxel
systemic therapy
measurable disease
carboplatin
tumor cells
gemcitabine
pembrolizumab
cancer chemotherapy
solid tumour
5-fluorouracil
mucosal melanoma

Summary

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

Description

This is an open-label, multicenter phase 1/2 study designed 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.

Details
Condition Malignant Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC)
Treatment cisplatin, carboplatin, Gemcitabine, Pembrolizumab, Nab-paclitaxel, 5-FU, GEN1042
Clinical Study IdentifierNCT04083599
SponsorGenmab
Last Modified on20 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Phase 1a
• Subjects with non-CNS solid tumors that is metastatic or unresectable and for whom there
is no available standard therapy
Phase 2a
• 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
Subjects with unresectable Stage III or Stage IV melanoma with no prior systemic
Phase 1b/Phase 2
anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal
Dose Escalation and Expansion
melanoma is excluded
Measurable disease according to RECIST 1.1
Subjects with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer
Eastern Cooperative Oncology Group (ECOG) 0-1
therapy, no actionable mutation and tumor demonstrating PD-L1 expression in ≥1% of
tumor cells (TPS ≥1%)
General (all phases)
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
Subjects with confirmed metastatic PDAC with no previous radiotherapy, surgery
Normal or adequate liver, renal, cardiac and bone marrow function
chemotherapy, or investigational therapy for the treatment of metastatic disease
Must be age ≥ 18 years of age

Exclusion Criteria

Phase 1a/Phase 2a
Phase 1b/Phase 2
Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of
General (all phases)
Radiotherapy within 14 days prior to first GEN1042 administration
Subject has an active, known, or suspected autoimmune disease
the drug, whichever is shorter), prior to GEN1042 administration
Toxicities from previous anti-cancer therapies that have not resolved
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
History of non-infectious pneumonitis that required steroids or currently has
pneumonitis
History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
Subject with a condition requiring systemic treatment with either corticosteroids (>10
mg daily prednisone equivalent) or other immunosuppressive medications within 14 days
of first treatment
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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