Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MCLA-158 · 1 trial · 8 indications
Evaluation of the number and severity of participants with treatment related toxicities observed during the dose escalation.
Incidence, severity, and relationship of AEs and SAEs
Treatment discontinuations due to AEs and dose modifications due to AEs
Evaluation of clinical benefit assessed by RECIST v1.1 determining Best overall response (BOR)
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective response rate (ORR)
Incidence of TEAEs at Week 8
Bioavailability of subcutaneous vs intravenous administration
Area under the concentration versus time curve from time zero to time t \[AUC0-t\]
Maximum plasma concentration as measured from all individual plasma concentrations
Minimum plasma concentration as measured from all individual plasma concentrations
| Arm | Type | Description |
|---|---|---|
| MCLA-158 (Single-Agent) | EXPERIMENTAL | In Part 1, the dose escalation phase, patients with metastatic CRC will receive escalating doses of MCLA-158 (every 2 weeks) until MTD or RP2D is reached. Each Cycle is 28 days. Single agent treatment. In Part 2, the expansion phase, participants with metastatic CRC and certain other solid tumors will receive intravenous infusion (i.v.) of MCLA-158 at the recommended Phase II dose (RP2D) every 2 weeks, at Day 1 and Day 15. The duration of each treatment cycle is 28 days. In addition, in the expansion phase, one randomized cohort will evaluate 2 doses (1100 mg and 1500 mg) of MCLA-158 in head and neck squamous cell carcinoma patients. Also in the expansion phase, a subcutaneous formulation of MCLA-158 will be evaluated. |
| MCLA-158 + Pembrolizumab | EXPERIMENTAL | MCLA-158 in combination with pembrolizumab will be explored first in head and neck squamous cell carcinoma patients eligible to receive pembrolizumab as first-line monotherapy. |
| MCLA-158 + FOLFIRI combination chemotherapy | EXPERIMENTAL | MCLA-158 in combination with FOLFIRI will be explored in mCRC patients with up to 1 line of prior regimen. |
| MCLA-158 + FOLFOX combination chemotherapy | EXPERIMENTAL | MCLA-158 in combination with FOLFOX will be explored in mCRC patients with up to 1 line of prior regimen. |
| Name | Type | Description |
|---|---|---|
| MCLA-158 | DRUG | full-length IgG1 bispecific antibody targeting EGFR and LGR5 |
| MCLA-158 + Pembrolizumab | COMBINATION_PRODUCT | MCLA-158 in combination with pembrolizumab will be explored first in HNSCC patients eligible to receive pembrolizumab as first-line monotherapy. |
| MCLA-158 + FOLFIRI | COMBINATION_PRODUCT | MCLA-158 in combination with FOLFIRI will be explored in mCRC patients with up to 1 line of prior regimen. |
| MCLA-158 + FOLFOX | COMBINATION_PRODUCT | MCLA-158 in combination with FOLFOX will be explored in mCRC patients with up to 1 line of prior regimen. |
Inclusion Criteria: * Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent. * A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe/feasible). * Amenable for bio...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
MCLA-158 is an investigational bispecific antibody being developed for the treatment of advanced or metastatic solid tumors, including colorectal cancer, gastric cancer, gastroesophageal-junction cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, and esophageal cancer. It is currently being studied in a Phase 1 clinical trial.
MCLA-158 targets EGFR, a receptor involved in cell growth and survival. By binding to EGFR, the bispecific antibody aims to interfere with signaling pathways that can drive tumor growth. This mechanism is being evaluated in patients with advanced solid tumors.
MCLA-158 is being developed by Merus N.V., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MRUS. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of MCLA-158 in patients with advanced solid tumors.
MCLA-158 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients with advanced or metastatic solid tumors to assess the drug's safety, tolerability, and preliminary efficacy.
MCLA-158 is being evaluated in a single Phase 1 clinical trial with the identifier NCT03526835. This study is recruiting patients with advanced solid tumors, including colorectal, gastric, and esophageal cancers, across multiple countries including the United States, Belgium, France, Italy, Netherlands, Spain, and the United Kingdom.
MCLA-158 is a bispecific antibody developed by Merus N.V. It is not known to have alternative names. The drug is being investigated under the clinical trial identifier NCT03526835 for the treatment of advanced solid tumors.