Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GEN1042 (DuoBody®-CD40x4-1BB)
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 bispecific monoclonal antibody being studied for the treatment of malignant solid tumors. It is in Phase 1 clinical development for oncology indications, including non-small cell lung cancer, colorectal cancer, melanoma, head and neck squamous cell carcinoma, and pancreatic ductal adenocarcinoma.
GEN1042 targets CD40 and 4-1BB, which are immune cell receptors. As a bispecific antibody, it is designed to engage both targets simultaneously, potentially modulating immune responses against tumors. This mechanism is under investigation in early-stage clinical trials for 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 Phase 1 clinical trials to evaluate the safety and anti-tumor activity of GEN1042 in patients with malignant solid tumors.
GEN1042 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are currently active, though not recruiting participants, to assess its safety and preliminary efficacy in solid tumor patients.
GEN1042 is being studied in two Phase 1 trials. NCT04083599 is a safety and anti-tumor activity trial enrolling 350 participants with various solid tumors across multiple countries. NCT06057038 is a safety trial enrolling 8 Japanese participants with malignant solid tumors.
GEN1042 is the primary name used in clinical trials and development. No alternative names have been reported for this investigational bispecific antibody. It is distinct from other Genmab pipeline assets and is specifically being evaluated for solid tumor indications.