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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04626635 | A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers | PHASE1 | RECRUITING | 933 | — | — | Dec 21, 2020 | Apr 7, 2027 | Apr 9, 2026 | 57 | United States, France +5 |
Dose escalation
Dose escalation
Dose escalation
Dose escalation
Dose escalation
Dose expansion
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Variety of mixed advanced solid tumor types |
| Dose Expansion A | EXPERIMENTAL | Triple Negative Breast Cancer (TNBC) |
| Dose Expansion B | EXPERIMENTAL | Cutaneous Squamous Cell Carcinoma (CSCC) |
| Dose Expansion C | EXPERIMENTAL | Non-Small Cell Lung Cancer (NSCLC) |
| Dose Expansion D | EXPERIMENTAL | Head and Neck Squamous Cell Carcinoma (HNSCC) |
| Dose Expansion E | EXPERIMENTAL | Microsatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases |
| Dose Expansion F | EXPERIMENTAL | MSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases) |
| Dose Expansion G | EXPERIMENTAL | Epidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI) |
| Dose Expansion H | EXPERIMENTAL | EGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy |
| Dose Expansion I | EXPERIMENTAL | Third-line (3L) MSS-CRC with Active Liver Metastases |
| Dose Expansion J | EXPERIMENTAL | 3L MSS-CRC without Active Liver Metastases |
| Name | Type | Description |
|---|---|---|
| REGN7075 | DRUG | Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W) |
| Cemiplimab | DRUG | Administered concomitantly Q3W by IV infusion or SC injection |
| Platinum-based doublet chemotherapy | DRUG | Administered IV Q3W |
| Bevacizumab | DRUG | Administered per protocol |
| Trifluridine-tipiracil | DRUG | Administered per protocol |
Key Inclusion Criteria: 1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 2. Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol 3. Expansion Cohorts only: Is anti-Programmed cell Death protein-1 (PD-1)/Programmed cell D...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |