Advanced Solid Tumor, AdultPhase 1/2ATTACCNCT04972110

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

A Phase 1/2 study testing RP-3500 (camonsertib) in people with Advanced Solid Tumor, Adult, run by Repare Therapeutics at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor, Adult
What is being tested?: RP-3500 (camonsertib)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 156 participants
Where: 13 sitesUnited States
Study dates: 21 Jul 2021to 13 Nov 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Participating Site #1015
Ann Arbor, Michigan, 48109
Participating Site #1028
Aurora, Colorado, 80012
Participating Site #1009
Baltimore, Maryland, 21205
Participating Site #1029
Eugene, Oregon, 97401
Participating Site # 1001
Houston, Texas, 77030
Participating Site #1017
Jacksonville, Florida, 32224
Participating Site #1012
New Haven, Connecticut, 06511
Participating Site #1026
New York, New York, 10029
Participating Site # 1008
New York, New York, 10032
Participating Site #1018
Phoenix, Arizona, 97401
Participating Site # 1016
Rochester, Minnesota, 55905
Participating Site # 1013
Salt Lake City, Utah, 84112
Participating Site #1025
San Francisco, California, 94158

Other trials in United States

About this study

Official title: Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC)

Read the 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).

Sponsor decided to terminate study early therefore, the Phase 2 expansion was not conducted

Conditions: Advanced Solid Tumor, Adult
Being tested: RP-3500 (camonsertib)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04972110
Study group	Role	What they receive
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 Receives: Drug: RP-3500 (camonsertib)
Phase 2 Expansion Cohorts	Experimental	Expansion cohort with RP-3500 (camonsertib) + niraparib and/or Expansion cohort RP-3500 (camonsertib) + olaparib Receives: Drug: RP-3500 (camonsertib)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 202113 Nov 2024

First posted22 Jul 2021
Study start21 Jul 2021
Primary completion13 Nov 2024
Study completion13 Nov 2024

Why it stopped: Sponsor decided to terminate study early therefore, the Phase 2 portion was not conducted

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced Solid Tumor, AdultStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Dose Escalation, expansion and Phase 2
Masking: None (open label)
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04972110
Sponsor's protocol ID: RP-3500-03
Acronym: ATTACC
Status last verified: Oct 2025
First submitted: 2 Jul 2021
Last updated: 30 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40705098

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Solid Tumor, Adult trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC)
ClinicalTrials.gov ID: NCT04972110
Acronym / sponsor ID: ATTACC / RP-3500-03
Conditions: Advanced Solid Tumor, Adult
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decided to terminate study early therefore, the Phase 2 portion was not conducted
Enrolment: 156 participants (actual)
Lead sponsor: Repare TherapeuticsIndustry (pharma, biotech, devices)
Study start: 21 Jul 2021 (actual)
Primary completion: 13 Nov 2024 (actual)
Study completion: 13 Nov 2024 (actual)
First posted: 22 Jul 2021 (actual)
Results: Posted 30 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Sponsor decided to terminate study early therefore, the Phase 2 expansion was not conducted

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Dose Escalation, expansion and Phase 2

Arm	Type	Receives
Phase Ib Dose Escalation	Experimental	Drug: RP-3500 (camonsertib)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
Phase 2 Expansion Cohorts	Experimental	Drug: RP-3500 (camonsertib)Expansion cohort with RP-3500 (camonsertib) + niraparib and/or Expansion cohort RP-3500 (camonsertib) + olaparib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RP-3500 (camonsertib)Also: niraparib, olaparibRP-3500 (camonsertib, ATR inhibitor) in combination with niraparib or olaparib (PARP inhibitors)	Drug	Phase 2 Expansion Cohorts, Phase Ib Dose Escalation

Primary outcome

Determine the Safety and Tolerability of Niraparib or Olaparib in Combination With RP-3500 in Patients With Molecularly Selected Solid Tumors
Time frame: Start of treatment to 30 days post last dose, up to 23.7 months
Treatment Related Treatment-Emergent Adverse Events (TRAE) with ≥3 CTCAE Grade
Define the Recommended Phase 2 Dose (RP2D) of RP-3500 in Combination With Niraparib or Olaparib in Patients With Molecularly Selected Solid Tumors
Time frame: During 21 days (one cycle) from the initiation of the study treatment
Frequency of DLTs during the DLT observation period

Results and safety

Results posted to the registry on 30 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: 50mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly	9	1
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, weekly	24	4
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly	3	1
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, 2 weeks on/1 week off	23	0
Arm 1: 70mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly	8	0
Arm 2: 50mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly	7	0
Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 3d on/4d off, weekly	19	1
Arm 2: 50mg QD camonsertib + 200 mg QD olaparib, 3d on/4 d off, weekly	5	1
Arm 2: 80mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly	3	1
Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, weekly	26	0
Arm 2: 80mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, 2w on/1w off	29	0

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

Time frame: Start of treatment to 30 days post last dose, up to 23.7 months. Count of participants. Unit: Participants

Measure	Arm 1: 50mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly n = 9	Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, weekly n = 24	Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly n = 3	Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, 2 weeks on/1 week off n = 23	Arm 1: 70mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly n = 8	Arm 2: 50mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly n = 7	Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 3d on/4d off, weekly n = 19	Arm 2: 50mg QD camonsertib + 200 mg QD olaparib, 3d on/4 d off, weekly n = 5	Arm 2: 80mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly n = 3	Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, weekly n = 26	Arm 2: 80mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, 2w on/1w off n = 29
Value	8	20	3	12	7	6	16	5	3	16	23

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

Time frame: During 21 days (one cycle) from the initiation of the study treatment. Count of participants. Unit: Participants

Measure	Arm 1: 50mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly n = 8	Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, weekly n = 22	Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly n = 3	Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, 2 weeks on/1 week off n = 22	Arm 1: 70mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly n = 8	Arm 2: 50mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly n = 6	Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 3d on/4d off, weekly n = 17	Arm 2: 50mg QD camonsertib + 200 mg QD olaparib, 3d on/4 d off, weekly n = 4	Arm 2: 80mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly n = 3	Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, weekly n = 26	Arm 2: 80mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, 2w on/1w off n = 27
Value	1	1	3	1	1	3	6	1	2	0	3

Adverse events

Time frame: Start of treatment to 30 days post lase dose, up to 34.7 months for Serious adverse events; Start of treatment to 30 days post last dose, up to 23.7 months for other adverse events. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: 50mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly	4 of 9 (44.4%)	9 of 9 (100%)	3 of 9
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, weekly	8 of 24 (33.3%)	24 of 24 (100%)	10 of 24
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 3d on/4d off, weekly	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Arm 1: 80mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, 2 weeks on/1 week off	7 of 23 (30.4%)	23 of 23 (100%)	8 of 23
Arm 1: 70mg QD camonsertib + 100mg QD niraparib, 2d on/5d off, weekly	3 of 8 (37.5%)	8 of 8 (100%)	1 of 8
Arm 2: 50mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly	1 of 7 (14.3%)	7 of 7 (100%)	4 of 7
Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 3d on/4d off, weekly	11 of 19 (57.9%)	19 of 19 (100%)	10 of 19
Arm 2: 50mg QD camonsertib + 200 mg QD olaparib, 3d on/4 d off, weekly	2 of 5 (40%)	5 of 5 (100%)	1 of 5
Arm 2: 80mg QD camonsertib + 150mg BID olaparib, 3d on/4d off, weekly	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Arm 2: 50mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, weekly	8 of 26 (30.8%)	26 of 26 (100%)	6 of 26
Arm 2: 80mg QD camonsertib + 100mg BID olaparib, 2d on/5d off, 2w on/1w off	8 of 29 (27.6%)	27 of 29 (93.1%)	5 of 29

Limitations and caveats (from the sponsor): The study was terminated early. And phase 2 portion of the study was not conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40705098Silverman 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RP-3500 (camonsertib) in people with Advanced Solid Tumor, Adult, run by Repare Therapeutics at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the Safety and Tolerability of Niraparib or Olaparib in Combination With RP-3500 in Patients With Molecularly Selected Solid Tumors (time frame: Start of treatment to 30 days post last dose, up to 23.7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04972110, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.