Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06057038 | A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 42 | — | — | Nov 24, 2023 | Nov 28, 2026 | Jun 2, 2026 | 3 | Japan |
| NCT04083599 | GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 350 | — | — | Sep 17, 2019 | Nov 1, 2026 | Jun 2, 2026 | 76 | United States, Denmark +10 |
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....