- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04972110
Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors (ATTACC)
November 2, 2023 updated by: Repare Therapeutics
Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a first-in-human Phase 1b/2, multi-center, open-label, dose-escalation and expansion study to:
- Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally in combination with niraparib or olaparib to establish the recommended Phase 2 dose and schedule.
- Characterize the PK profile of RP-3500 (camonsertib) in combination with niraparib or olaparib
- Assess anti-tumor activity associated with RP-3500 (camonsertib) in combination with niraparib or olaparib
- Examine biomarker responses and establish a correlation with RP-3500 (camonsertib) treatment in combination with niraparib or olaparib.
After the RP2D and schedule is determined, expansion cohort(s) for RP-3500 (camonsertib) in combination with niraparib or olaparib will be enrolled to study the anti-tumor effect, and further examine the safety, PK, and pharmacodynamic (PD).
Study Type
Interventional
Enrollment (Estimated)
196
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabriela Gomez, MD, MBA
- Phone Number: 1 (857) 340-5402
- Email: clininfo@reparerx.com
Study Contact Backup
- Name: Paul Basciano, MD
- Phone Number: 1 (857) 340-5402
- Email: clininfo@reparerx.com
Study Locations
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Arizona
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Phoenix, Arizona, United States, 97401
- Recruiting
- Participating Site #1018
-
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California
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San Francisco, California, United States, 94158
- Recruiting
- Participating Site #1025
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Colorado
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Aurora, Colorado, United States, 80012
- Recruiting
- Participating Site #1028
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Connecticut
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New Haven, Connecticut, United States, 06511
- Recruiting
- Participating Site #1012
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Florida
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Jacksonville, Florida, United States, 32224
- Recruiting
- Participating Site #1017
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Maryland
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Baltimore, Maryland, United States, 21205
- Recruiting
- Participating Site #1009
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- Participating Site #1015
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Participating site # 1016
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New York
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New York, New York, United States, 10032
- Recruiting
- Participating Site # 1008
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New York, New York, United States, 10029
- Recruiting
- Participating Site #1026
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Oregon
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Eugene, Oregon, United States, 97401
- Recruiting
- Participating Site #1029
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- Participating Site # 1001
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Utah
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Salt Lake City, Utah, United States, 84112
- Recruiting
- Participating Site # 1013
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase Ib Dose Escalation
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
|
RP-3500 (camonsertib, ATR inhibitor) in combination with niraparib or olaparib (PARP inhibitors)
Other Names:
|
Experimental: Phase 2 Expansion Cohorts
Expansion cohort with RP-3500 (camonsertib) + niraparib and/or Expansion cohort RP-3500 (camonsertib) + olaparib
|
RP-3500 (camonsertib, ATR inhibitor) in combination with niraparib or olaparib (PARP inhibitors)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase Ib - Safety and Tolerability of niraparib or olaparib in combination with RP-3500 (camonsertib) by assessing the grade and frequency of adverse events and serious adverse events.
Time Frame: Up to 30 days after last administration of study intervention
|
To determine the safety and tolerability of niraparib or olaparib in combination with RP-3500 (camonsertib) in patients with advanced solid tumors by assessing the grade and frequency of adverse events and serious adverse events
|
Up to 30 days after last administration of study intervention
|
Primary Phase 1b - Define Maximum Tolerated Dose of RP-3500-03 (camonsertib) in combination with niraparib or olaparib and Recommended Phase 2 Dose and preferred schedule by assessing frequency of Dose Limiting Toxicities observed at each dose level
Time Frame: At the end of cycle 1 (each cycle is 21 or 28 days)
|
To define the Maximum Tolerated Dose of RP-3500-03 (camonsertib) in combination with niraparib or olaparib and determine Recommended Phase 2 Dose and preferred schedule by assessing the frequency of Dose Limiting Toxicities observed at each dose level
|
At the end of cycle 1 (each cycle is 21 or 28 days)
|
Primary Phase 2 - Assess preliminary anti-tumor activity of RP-3500 (camonsertib) with niraparib or olaparib in patients with eligible advanced solid tumors
Time Frame: While on study therapy, every 6 weeks for first 5 months and then every 9 weeks thereafter
|
To preliminarily assess the antitumor activity of RP-3500 (camonsertib) with niraparib or olaparib in patients with eligible advanced solid tumors by Response evaluation criteria (RECIST 1.1 CA-125 per GCIG, and PSA per PCWG3)
|
While on study therapy, every 6 weeks for first 5 months and then every 9 weeks thereafter
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess PK parameters of RP-3500 (camonsertib) in combination with niraparib or olaparib -Cmax
Time Frame: Through Cycle 1 and 2 (each cycle is 21 days)
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To assess plasma concentrations of RP-3500 (camonsertib) and niraparib or olaparib with calculations of maximum observed plasma concentration (Cmax)
|
Through Cycle 1 and 2 (each cycle is 21 days)
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To assess PK parameters of RP-3500 (camonsertib) in combination with niraparib or olaparib -Tmax
Time Frame: Through Cycle 1 and 2 (each cycle is 21 days)
|
To assess plasma concentrations of RP-3500 (camonsertib) and niraparib or olaparib with calculations of time to maximum observed plasma concentration (Tmax)
|
Through Cycle 1 and 2 (each cycle is 21 days)
|
To assess PK parameters of RP-3500 (camonsertib) in combination with niraparib or olaparib - AUC
Time Frame: Through Cycle 1 and 2 (each cycle is 21 days)
|
To assess plasma concentrations of RP-3500 (camonsertib) and niraparib or olaparib with calculations of area under the plasma concentration-time curve 0-6 hours post dose (AUC0-6).
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Through Cycle 1 and 2 (each cycle is 21 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2021
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
July 2, 2021
First Submitted That Met QC Criteria
July 16, 2021
First Posted (Actual)
July 22, 2021
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RP-3500-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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