A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors

Conditions

• Advanced or Metastatic Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PLN-101095 — DRUG
  PLN-101095 250 mg BID
• PLN-101095 — DRUG
  PLN-101095 500 mg BID
• PLN-101095 — DRUG
  PLN-101095 1000 mg BID
• PLN-101095 — DRUG
  PLN-101095 1000 mg TID
• PLN-101095 — DRUG
  PLN-101095 2000 mg BID
• PLN-101095 — DRUG
  PLN-101095
• Pembrolizumab — DRUG
  Pembrolizumab (KEYTRUDA) 200 mg IV Q3W

Study Details

This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab. The study will consist of 2 main parts: * Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration * Part 2: Dose-expansion cohorts using Simon's 2-stage design

Key Dates

Start date

Aug 30, 2023

Status verified

Apr 2026

Primary completion

Jun 30, 2030

Completion

Jun 30, 2030

Study Design

Enrollment

124 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Dose Escalation - 250 mg BID
  Cohort 1 PLN-101095 250 mg BID in combination with pembrolizumab in participants with solid tumors
• Experimental: Part 1 Dose Escalation - 500 mg BID
  PLN-101095 500 mg BID in combination with pembrolizumab in participants with solid tumors
• Experimental: Part 1 Dose Escalation - 1000 mg BID
  PLN-101095 1000 mg BID in combination with pembrolizumab in participants with solid tumors
• Experimental: Part 1 Dose Escalation - 1000 mg TID
  PLN-101095 1000 mg TID in combination with pembrolizumab in participants with solid tumors
• Experimental: Part 1 Dose Escalation - 2000 mg BID
  PLN-101095 2000 mg BID in combination with pembrolizumab in participants with solid tumors
• Experimental: Part 2 Dose Expansion - NSCLC
  PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Non-small cell lung cancer (NSCLC)
• Experimental: Part 2 Dose Expansion - ccRCC
  PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Clear cell renal cell carcinoma (ccRCC)
• Experimental: Part 2 Dose Expansion - TMB-high solid tumors
  PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Tumor mutational burden (TMB)-high solid tumors

Primary Outcome Measure

Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2 [ Time Frame: First dose to 35 days ]

Central Contacts

• Pliant Therapeutics Medical Monitor
  [email protected]
  [email protected]

Locations (6)

Find similar trials in New Haven, CT

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