Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors

NCT04972110 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: RP-3500-03
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 13

Brief Summary

The primary purpose of this study is to assess the safety and tolerability of niraparib or olaparib in combination with RP-3500 (camonsertib), in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 (camonsertib) in combination with niraparib or olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.

Conditions

Advanced Solid Tumor, Adult

Outcome Measures

Primary Outcomes (2)

• Determine the Safety and Tolerability of Niraparib or Olaparib in Combination With RP-3500 in Patients With Molecularly Selected Solid Tumors

  Treatment Related Treatment-Emergent Adverse Events (TRAE) with ≥3 CTCAE Grade

  Start of treatment to 30 days post last dose, up to 23.7 months

• Define the Recommended Phase 2 Dose (RP2D) of RP-3500 in Combination With Niraparib or Olaparib in Patients With Molecularly Selected Solid Tumors

  Frequency of DLTs during the DLT observation period

  During 21 days (one cycle) from the initiation of the study treatment

Study Arms (2)

Phase Ib Dose Escalation

EXPERIMENTAL

Multiple dose levels of RP-3500 (camonsertib) for oral administration in combination with niraparib and/or Multiple dose levels of RP-3500 (camonsertib) for oral administration in combination with olaparib

Drug: RP-3500 (camonsertib)

Phase 2 Expansion Cohorts

EXPERIMENTAL

Expansion cohort with RP-3500 (camonsertib) + niraparib and/or Expansion cohort RP-3500 (camonsertib) + olaparib

Drug: RP-3500 (camonsertib)

Interventions

RP-3500 (camonsertib) DRUG

RP-3500 (camonsertib, ATR inhibitor) in combination with niraparib or olaparib (PARP inhibitors)

Also known as: niraparib, olaparib

Phase 2 Expansion Cohorts; Phase Ib Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female and ≥18 years-of-age at the time of signature of the informed consent
• Confirmed advanced solid tumors resistant or refractory to standard treatment
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Evaluable disease as per RECIST v1.1
• Next generation sequencing (NGS) report obtained in CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarkers.
• Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible
• Acceptable hematologic and organ function at screening
• Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug.
• Ability to swallow and retain oral medications.

You may not qualify if:

• Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.
• Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 10 days or 5 half-lives (whichever is longer), prior to first dose of study drug.
• Use of radiotherapy (except for palliative reasons) within 7 days prior to first dose of study drug.
• History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
• No other anticancer therapy is to be permitted while the patient is receiving study treatment.
• Major surgery ≤28 days or minor surgical procedures ≤7 days prior to first study treatment dose.
• Uncontrolled, symptomatic brain metastases.
• Uncontrolled high blood pressure
• History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
• Presence of other known active invasive cancers.
• Pregnant or breastfeeding women.
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study protocol and/or follow-up procedures outlined in the protocol.

Sponsors & Collaborators

• Repare Therapeutics: lead

Study Sites (13)

Participating Site #1018

Phoenix, Arizona, 97401, United States

Location

Participating Site #1025

San Francisco, California, 94158, United States

Location

Participating Site #1028

Aurora, Colorado, 80012, United States

Location

Participating Site #1012

New Haven, Connecticut, 06511, United States

Location

Participating Site #1017

Jacksonville, Florida, 32224, United States

Location

Participating Site #1009

Baltimore, Maryland, 21205, United States

Location

Participating Site #1015

Ann Arbor, Michigan, 48109, United States

Location

Participating Site # 1016

Rochester, Minnesota, 55905, United States

Location

Participating Site #1026

New York, New York, 10029, United States

Location

Participating Site # 1008

New York, New York, 10032, United States

Location

Participating Site #1029

Eugene, Oregon, 97401, United States

Location

Participating Site # 1001

Houston, Texas, 77030, United States

Location

Participating Site # 1013

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Silverman IM, Schonhoft JD, Herzberg B, Yablonovitch A, Lagow E, Fiaux PC, Safabakhsh P, Sethuraman S, Ulanet D, Yang J, Kim I, Basciano P, Cecchini M, Lee E, Lheureux S, Fontana E, Carneiro BA, Reis-Filho JS, Yap TA, Zinda M, Rosen EY, Rimkunas V. Genomic and Epigenomic ctDNA Profiling in Liquid Biopsies from Heavily Pretreated Patients with DNA Damage Response-Deficient Tumors. Clin Cancer Res. 2025 Oct 1;31(19):4136-4149. doi: 10.1158/1078-0432.CCR-25-1248.

  PMID: 40705098 DERIVED

MeSH Terms

Interventions

niraparib; olaparib

Limitations and Caveats

The study was terminated early. And phase 2 portion of the study was not conducted.

Results Point of Contact

• Title: Repare Therapeutics Medical Monitor
• Organization: Repare Therapeutics Inc

clininfo@reparerx.com

1 (857) 340-5402

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose Escalation, expansion and Phase 2

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 22, 2021
• Study Start: July 21, 2021
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)