Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as REGN7075
Marlotamig · 1 trial · 1 indication
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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Marlotamig is an investigational therapy being studied in adults with advanced solid tumors. It is being evaluated in combination with cemiplimab, another Regeneron therapy, in a Phase 1 clinical trial. It is not approved for any indication and remains in clinical development.
Marlotamig targets EGFR, a protein that is overexpressed or mutated in many solid tumors. By binding to EGFR, the drug is designed to interfere with signaling that drives tumor cell growth and survival. It is being studied in advanced solid tumors.
Marlotamig is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is running the clinical program evaluating Marlotamig in combination with cemiplimab in patients with advanced solid tumors.
Marlotamig is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 program is evaluating its safety and activity in adults with advanced solid tumors.
Marlotamig is being studied in NCT04626635, a Phase 1 trial titled "A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers." The trial is active but not recruiting, with an enrollment of 548 participants across the United States, France, Israel, Netherlands, Poland, Spain, and Turkey.
Yes, Marlotamig is also known as REGN7075. REGN7075 is Regeneron's internal development code for the same investigational compound. Both names refer to the EGFR-targeted therapy being studied in Phase 1 for advanced solid tumors in combination with cemiplimab.