Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PLN-101095 · 1 trial · 1 indication
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 | 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 |
PLN-101095 is an investigational small molecule developed by Pliant Therapeutics, Inc. for the treatment of advanced or metastatic solid tumors. It is being studied in a Phase 1 clinical trial and has received a Fast Track designation from the FDA. It is not yet approved for any indication.
PLN-101095 is being evaluated as a treatment for adults with advanced or metastatic solid tumors. It is an investigational therapy in Phase 1 development, so it is not currently approved for use in this or any other indication. The trial enrolls patients 18 years and older.
PLN-101095 targets the integrins alpha-v beta-8 (αvβ8) and alpha-v beta-1 (αvβ1). These integrin receptors are the molecular targets of the small molecule, which is being developed in oncology for advanced or metastatic solid tumors. The dual integrin targeting is the basis of its investigational mechanism.
PLN-101095 is being developed by Pliant Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol PLRX. The company is the sponsor of the Phase 1 study evaluating the drug in adults with advanced or metastatic solid tumors in the United States and Spain.
PLN-101095 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The FDA has granted PLN-101095 a Fast Track designation, which is intended to facilitate development of drugs addressing serious conditions with unmet medical need.
PLN-101095 is being studied in one active clinical trial, NCT06270706, titled A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors. The trial is currently recruiting, plans to enroll 124 participants, and is being conducted in the United States and Spain.