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Study of RP-3500, Camonsertib, in Advanced Solid Tumors

NCT04497116 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2025-10-21

Study results available
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Summary

The primary purpose of this study is to define the maximum tolerated dose (MTD) and determine a recommended Phase 2 dose (RP2D) and schedule of orally-administered RP-3500 (camonsertib) alone or in combination with talazoparib, a PARP inhibitor, or Gemcitabine in patients with advanced solid tumors with ATR inhibitor-sensitizing mutations. This study will also evaluate the safety and tolerability of RP-3500 (camonsertib) alone or in combination with talazoparib or gemcitabine, examine both the pharmacokinetics (PK)and pharmacodynamics (PD)and investigate its anti-tumor activity in solid tumors.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

RP-3500 (camonsertib)

Oral ATR inhibitor

DRUG

Talazoparib

Oral PARP inhibitor

DRUG

Gemcitabine Injection

Gemcitabine

Sponsors & Collaborators

  • Repare Therapeutics

    lead INDUSTRY

Principal Investigators

  • Timothy A Yap, MBBS PhD FRCP · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2025-06-13
Completion
2025-06-13
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04497116 on ClinicalTrials.gov