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 | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
PLN-101095 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in adults with advanced or metastatic solid tumors.
PLN-101095 targets the integrins αvβ8 and αvβ1. These are cell surface receptors involved in cell adhesion and signaling. By targeting these integrins, PLN-101095 aims to modulate pathways relevant to tumor progression in advanced or metastatic solid tumors.
PLN-101095 is being developed by Pliant Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PLRX. The company is conducting clinical trials to evaluate the safety and efficacy of PLN-101095 in patients with advanced or metastatic solid tumors.
PLN-101095 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and pharmacokinetics in adults with advanced or metastatic solid tumors.
PLN-101095 is being studied in a Phase 1 clinical trial with the identifier NCT06270706. This trial is titled 'A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors' and is currently recruiting participants in the United States. The trial has an estimated enrollment of 124 participants.
Yes, PLN-101095 has received Fast Track designation from the FDA. This designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. PLN-101095 is being developed for advanced or metastatic solid tumors.