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Trial Title:
Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors
NCT ID:
NCT06560632
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Olaparib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RP-3467 at assigned dose and schedule
Description:
Eligible participants will be treated with escalating doses of RP-3467 monotherapy
Arm group label:
Arm 1: RP-3467 monotherapy
Arm group label:
Arm2: RP-3467 + Olaparib combination
Intervention type:
Drug
Intervention name:
Olaparib 200-300 mg BID, daily
Description:
Eligible participants will be treated with escalating doses of RP-3467 in combination
with Olaparib
Arm group label:
Arm2: RP-3467 + Olaparib combination
Other name:
RP-3467 at assigned dose and schedule
Other name:
Lynparza
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.
Detailed description:
This is a first-in-human Phase 1, multi-center, open-label, dose-escalation study to:
- Evaluate the safety profile of RP-3467 when administered orally alone and in
combination with olaparib and to define the MTD or MAD for RP-3467 monotherapy and
the RP2D for the combination
- Characterize the PK profile of RP-3467 alone and in combination with olaparib
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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:
1. locally advanced or metastatic epithelial ovarian cancer (including fallopian
tube or primary peritoneal), or
2. metastatic breast cancer, or
3. metastatic castration-resistant prostate cancer (mCRPC), or
4. 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Participating Site #1025
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Facility:
Name:
Participating Site # 1008
Address:
City:
New York
Zip:
10032
Country:
United States
Facility:
Name:
Participating Site # 1004
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Participating Site # 1001
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
October 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Repare Therapeutics
Agency class:
Industry
Source:
Repare Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06560632
