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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03526835 | A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors | PHASE1 | RECRUITING | 523 | — | — | May 2, 2018 | Nov 1, 2027 | Jan 29, 2025 | 45 | United States, Belgium +4 |
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
| Arm | Type | Description |
|---|---|---|
| MCLA-158 | 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 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. |
| 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, 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 |