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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06270706 | A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | 124 | — | — | Aug 30, 2023 | Jun 1, 2030 | Apr 20, 2026 | 6 | United States |
Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications.
Proportion of participants achieving confirmed iPR or iCR per iRECIST Version 1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation - 250 mg BID | EXPERIMENTAL | Cohort 1 PLN-101095 250 mg BID in combination with pembrolizumab in participants with solid tumors |
| Part 1 Dose Escalation - 500 mg BID | EXPERIMENTAL | PLN-101095 500 mg BID in combination with pembrolizumab in participants with solid tumors |
| Part 1 Dose Escalation - 1000 mg BID | EXPERIMENTAL | PLN-101095 1000 mg BID in combination with pembrolizumab in participants with solid tumors |
| Part 1 Dose Escalation - 1000 mg TID | EXPERIMENTAL | PLN-101095 1000 mg TID in combination with pembrolizumab in participants with solid tumors |
| Part 1 Dose Escalation - 2000 mg BID | EXPERIMENTAL | PLN-101095 2000 mg BID in combination with pembrolizumab in participants with solid tumors |
| Part 2 Dose Expansion - NSCLC | EXPERIMENTAL | PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Non-small cell lung cancer (NSCLC) |
| Part 2 Dose Expansion - ccRCC | EXPERIMENTAL | PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Clear cell renal cell carcinoma (ccRCC) |
| Part 2 Dose Expansion - TMB-high solid tumors | EXPERIMENTAL | PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Tumor mutational burden (TMB)-high solid tumors |
| Name | Type | Description |
|---|---|---|
| PLN-101095 | DRUG | PLN-101095 250 mg BID |
| Pembrolizumab | DRUG | Pembrolizumab (KEYTRUDA) 200 mg IV Q3W |
Inclusion Criteria: 1. Has histologically or cytologically confirmed advanced or metastatic solid tumor 2. Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies 3. Have demonstrated documented prior clin...
| 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 |