GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors
Purpose
To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors.
Conditions
- Malignant Solid Tumor
- Non Small Cell Lung Cancer (NSCLC)
- Colorectal Cancer (CRC)
- Melanoma
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Pancreatic Ductal Adenocarcinoma (PDAC)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Monotherapy - Dose Escalation and Dose Expansion Parts - Subjects 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 - Subjects 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. - Subjects 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 on the day of signing informed consent, or the legal age of consent in the jurisdiction in which the trial is taking place. - 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) - Subject 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 - 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Monotherapy - Dose Escalation and Dose Expansion parts |
Escalating doses of GEN1042 monotherapy in subjects with non-central nervous system (CNS) solid malignant tumors followed by monotherapy expansion cohorts at selected dose(s) in subjects with relapsed or refractory, advanced and/or metastatic melanoma, or non-small-cell lung cancer (NSCLC), or colorectal cancer (CRC). |
|
Experimental Combination Therapy - Dose Expansion Part |
GEN1042 safety and efficacy will be evaluated in combination with pembrolizumab with or without chemotherapy in treatment-naive subjects with advanced or metastatic melanoma, non-small-cell lung cancer [NSCLC], head and neck squamous cell carcinoma [HNSCC], and pancreatic cancer. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT04083599
- Status
- Recruiting
- Sponsor
- Genmab
Detailed Description
This is an open-label, multicenter phase 1/2 study designed to assess the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of GEN1042 administered as a monotherapy or in combination in subjects with metastatic or locally advanced solid tumors.