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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| 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 is not yet approved by the FDA. The drug is being studied in adults aged 18 years and older with 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 a Phase 1 clinical trial of PLN-101095 in the United States for the treatment of 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 study is actively recruiting participants with advanced or metastatic solid tumors in the United States.
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 study has a planned enrollment of 124 participants.
Yes, the Phase 1 clinical trial of PLN-101095 is a controlled study. However, it is not randomized and not double-blind. The trial is open to all sexes and enrolls adults aged 18 years and older with advanced or metastatic solid tumors.