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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03175224 | APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors | PHASE2 | RECRUITING | 497 | — | — | Sep 27, 2017 | Nov 30, 2026 | Jun 27, 2025 | 35 | United States, Australia +9 |
Anti-tumor activity per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
| Arm | Type | Description |
|---|---|---|
| NSCLC Exon 14 Skip Treatment Naive | EXPERIMENTAL | Cohort A-1: APL-101 Oral Capsules |
| NSCLC Exon 14 Skip Previously Treated | EXPERIMENTAL | Cohort A-2: APL-101 Oral Capsules |
| NSCLC Exon 14 MET Inhibitor Experienced | EXPERIMENTAL | Cohort B: APL-101 Oral Capsules |
| Basket of tumor types MET amplification except for primary CNS tumors | EXPERIMENTAL | Cohort C: APL-101 Oral Capsules |
| NSCLC MET amplification and EGFR wild-type | EXPERIMENTAL | Cohort C-1: APL-101 Oral Capsules |
| EGFR positive NSCLC MET amplification as an acquired resistance | EXPERIMENTAL | Cohort C-2: APL-101 Oral Capsules + Standard of Care EGFR Inhibitor |
| Basket of solid tumor with MET gene fusions except for primary CNS tumors | EXPERIMENTAL | Cohort D: APL-101 Oral Capsules |
| Primary CNS tumors with MET alterations | EXPERIMENTAL | Cohort E: APL-101 Oral Capsules |
| Basket of tumor types wild-type MET with over-expression of HGF and MET | EXPERIMENTAL | Cohort F: APL-101 Oral Capsules |
| Name | Type | Description |
|---|---|---|
| APL-101 Oral Capsules | DRUG | Subjects will receive APL-101 capsules BID for oral administration. |
Major Inclusion Criteria: 1. Men and women 18 years of age or older. 2. 9 cohorts will be enrolled: * Cohort A1 / Exon 14 NSCLC MET inhibitor naive in first line: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies; unresectable or metastatic disease...
| 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 |