Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GEN1042 · 2 trials · 6 indications
Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version (v) 5.0.
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Toxicities will be graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0
ORR is defined as the percentage of participants with best overall response (BOR) \[complete or partial response (PR or CR)\] based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator.
| Arm | Type | Description |
|---|---|---|
| Monotherapy (non-CNS Malignant Solid Tumors): GEN1042 | EXPERIMENTAL | - |
| Combination Therapy Cohort 1 [HNSCC]: GEN1042+Pembro+Chemotherapy | EXPERIMENTAL | - |
| Combination Therapy Cohort 2 [HNSCC and NSCLC]: GEN1042+Pembro | EXPERIMENTAL | - |
| Combination Therapy Cohort 3 [HNSCC]: GEN1042+Pembro+Chemotherapy | EXPERIMENTAL | - |
| Combination Therapy Cohort 4 [HNSCC and NSCLC]: GEN1042+Pembro | EXPERIMENTAL | - |
| Monotherapy - Dose Escalation and Dose Expansion Parts | EXPERIMENTAL | - |
| Combination Therapy - Safety Run-in and Expansion Parts | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GEN1042 | BIOLOGICAL | Intravenous |
| Pembrolizumab | DRUG | Intravenous |
| Cisplatin | DRUG | Intravenous |
| Carboplatin | DRUG | Intravenous |
| 5-Fluorouracil | DRUG | Intravenous |
| 5-FU | DRUG | Intravenous |
| Gemcitabine | DRUG | Intravenous |
| Nab paclitaxel | DRUG | Intravenous |
| Pemetrexed | DRUG | Intravenous |
| Paclitaxel | DRUG | Intravenous |
Key Inclusion Criteria: 1. Must have measurable disease according to RECIST v1.1. 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 3. Acceptable organ and bone marrow function. 4. Participant must have a life expectancy of at least 3 months. Key Exclusion Criteria: 1....
GEN1042 is an investigational monoclonal antibody being studied for the treatment of malignant solid tumors, including non-small cell lung cancer, colorectal cancer, melanoma, head and neck squamous cell carcinoma, and pancreatic ductal adenocarcinoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
GEN1042 targets CD40 and 4-1BB, two proteins involved in immune system regulation. By engaging these targets, the antibody is designed to modulate immune responses against tumor cells. This bispecific mechanism is being evaluated in early-stage clinical trials for its potential anti-tumor activity in patients with malignant solid tumors.
GEN1042 is being developed by Genmab A/S, a biotechnology company listed on the Nasdaq under the ticker GMAB. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with malignant solid tumors.
GEN1042 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trials are designed to assess its safety, tolerability, and preliminary anti-tumor activity in patients with malignant solid tumors.
GEN1042 is being evaluated in two Phase 1 clinical trials. NCT04083599 is an active, non-recruiting study with 350 participants across multiple countries, including the United States, Denmark, and Japan. NCT06057038 is a separate trial in Japanese subjects with malignant solid tumors, enrolling 8 participants. Both trials are active but not currently recruiting.
GEN1042 is a distinct investigational monoclonal antibody developed by Genmab A/S. It is not known to be identical to any other approved or investigational drug. Its unique mechanism targets both CD40 and 4-1BB, setting it apart from other cancer immunotherapies in development.