Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors

NCT06560632 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: RP-3467-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, open-label Phase 1 trial to investigate the safety, PK, and pharmacodynamics of the Polθ inhibitor RP-3467 alone or in combination with the poly-ADP ribose polymerase inhibitor (PARPi) olaparib in adults with molecularly selected advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Who Experienced Dose-limiting Toxicities (DLT) During the Study Treatment

  The assessment of DLTs was conducted to evaluate the safety and tolerability of RP-3467 administered as monotherapy and in combination with olaparib in participants with advanced solid tumors.

  Start of treatment to 30 days post last dose, up to 13 months

Study Arms (2)

Arm 1: RP-3467 monotherapy

EXPERIMENTAL

Eligible participants will be treated with escalating doses of RP-3467 monotherapy

Drug: RP-3467 at assigned dose and schedule

Arm2: RP-3467 + Olaparib combination

EXPERIMENTAL

Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib

Drug: RP-3467 at assigned dose and schedule; Drug: Olaparib 200-300 mg BID, daily

Interventions

RP-3467 at assigned dose and schedule DRUG

Eligible participants will be treated with escalating doses of RP-3467 monotherapy

Arm 1: RP-3467 monotherapy; Arm2: RP-3467 + Olaparib combination

Olaparib 200-300 mg BID, daily DRUG

Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib

Also known as: RP-3467 at assigned dose and schedule, Lynparza

Arm2: RP-3467 + Olaparib combination

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 participants ≥18 years of age at the time of signing the informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Participant must have one of the following that has progressed or was non-responsive to prior systemic therapy and for which no standard or available known therapeutic option exists:
• locally advanced or metastatic epithelial ovarian cancer (including fallopian tube or primary peritoneal), or
• metastatic breast cancer, or
• metastatic castration-resistant prostate cancer (mCRPC), or
• pancreatic adenocarcinoma
• Measurable disease per RECIST v1.1 (exceptions for participants with non-measurable but evaluable disease \[per RECIST and or PSA/CA-125\])
• Next generation sequencing (NGS) report demonstrating eligible tumor biomarker
• Provision of archival tumor tissue, or if adequate archival tumor tissue is not available, provision of a fresh biopsy if there is a lesion that can be safely biopsied
• Acceptable organ function at Screening
• Acceptable hematologic function at Screening
• Life expectancy ≥12 weeks after the start of the treatment according to the Investigator's judgment

You may not qualify if:

• 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.
• Uncontrolled, symptomatic brain metastases.
• Presence of other known active invasive cancers
• History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
• Prior therapy with a Polθ inhibitor other than RP-3467

Sponsors & Collaborators

• Repare Therapeutics: lead

Study Sites (5)

# 1025, The University of California

San Francisco, California, 94158, United States

Location

# 1011, The Washington University

St Louis, Missouri, 63130, United States

Location

# 1008, Columbia University

New York, New York, 10032, United States

Location

# 1004, Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

# 1001, The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Appointments and Schedules; olaparib; BID protein, human

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Limitations and Caveats

The Study was terminated early by the Sponsor

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
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 19, 2024
• Study Start: September 17, 2024
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2025-12

Locations

US (5)