Advanced Solid TumorPhase 1/2TRESRNCT04497116

Study of RP-3500, Camonsertib, in Advanced Solid Tumors

A Phase 1/2 study testing RP-3500 (camonsertib), Talazoparib and Gemcitabine Injection in people with Advanced Solid Tumor, run by Repare Therapeutics at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor
What is being tested?: RP-3500 (camonsertib), Talazoparib and Gemcitabine Injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 13 sitesin 4 countries
Study dates: 22 Jul 2020to 13 Jun 2025
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

Written informed consent, according to local guidelines, signed and dated by the patient or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses.
Male or female and ≥ 18 years-of-age at the time of signature of the consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Histologically confirmed solid tumors resistant or refractory to standard treatment and/or patients who are intolerant to standard therapy.
Measurable disease as per RECIST v1.1
Existing biomarker profile (tumor tissue or plasma) reported from a local test obtained in a certified lab per institutional guidelines:

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Available tumor tissue
Ability to comply with the protocol and study procedures detailed in the Schedule of Assessments.
Ability to swallow and retain oral medications.
Acceptable organ function at screening
Acceptable blood counts at screening
Negative pregnancy test (serum) for females of childbearing potential at Screening and prior to first study drug.
Resolution of all toxicities of prior treatment or surgery.
Male patients with female partners of childbearing potential and females of childbearing potential must follow a contraception method (oral contraceptives allowed) during their participation in the study and for at least 6 months following last dose of study drug. Male patients must also refrain from donating sperm during their participation in the study and for 6 months following last dose of study drug.
Life expectancy ≥12 weeks after the start of the treatment according to the investigator's judgment.
Module 1c only: Ability to consume a high-fat meal and fast for 12 hours.

Who cannot join

Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 14 days prior to first dose of study drug.
History or current condition (such as transfusion dependent anemia or thrombocytopenia), 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.
Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.
Known hypersensitivity to any of the ingredients of RP-3500 (camonsertib).
Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the patient's safety.
Uncontrolled, symptomatic brain metastases.

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Uncontrolled high blood pressure
Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
Moderate or severe hepatic impairment (ie, Child-Pugh class B or C).
History or presence of an abnormal ECG that is clinically significant in the investigator's opinion.
History of ventricular dysrhythmias or risk factors such as structural heart disease, coronary heart disease (clinically significant electrolyte abnormalities or family history of sudden unexplained death or long QT syndrome
Current treatment with medications that are well-known to prolong the QT interval
History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
Module 3 only: Known sensitivity to any of the ingredients of talazoparib.

Trial locations and contacts

13 sites in 4 countries.

Country

City, postcode or hospital

13 sites in 4 countries

United States8 sites

#1006, Massachusetts General Hospital
Boston, Massachusetts, 02114
#1002, Dana Farber Cancer Institute
Boston, Massachusetts, 02215
#1014, Northwestern University
Chicago, Illinois, 60611
#1005, Duke Cancer Institute
Durham, North Carolina, 27710
#1001, The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
#1003, Sarah Cannon Research Institute
Nashville, Tennessee, 37203
#1004, Memorial Sloan Kettering Cancer Institute
New York, New York, 10065
#1007, Rhode Island Hospital
Providence, Rhode Island, 02903

Other trials in United States

United Kingdom3 sites

#3003, Sarah Cannon Research Institute
London, W1G 6AD
#3001, The Christie NHS Foundation Trust
Manchester, M20 4BX
#3002, Freeman Hospital Newcastle
Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Canada1 site

#2001, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9

Other trials in Canada

Denmark1 site

#4001, Copenhagen University Hospital Rigshospitalet - Blegdamsvej
Copenhagen, DK, 2100 Ø

Other trials in Denmark

About this study

Official title: Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination With Talazoparib or Gemcitabine in Advanced Solid Tumors With ATR Inhibitor Sensitizing Mutations (TRESR Study)

The primary purpose of this study is to define the maximum tolerated dose (MTD) and determine a recommended Phase 2 dose (RP2D) and schedule of orally-administered RP-3500 (camonsertib) alone or in combination with talazoparib, a PARP inhibitor, or Gemcitabine in patients with advanced solid tumors with ATR inhibitor-sensitizing mutations. This study will also evaluate the safety and tolerability of RP-3500 (camonsertib) alone or in combination with talazoparib or gemcitabine, examine both the pharmacokinetics (PK)and pharmacodynamics (PD)and investigate its anti-tumor activity in solid tumors.

Read the detailed description

This is a first-in-human, Phase 1/2a, multi-center, open-label, dose-escalation and expansion study to:

Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally, alone and in combination with talazoparib or gemcitabine, to establish the dose and schedule recommended for the Phase 2
Characterize the PK profile of RP-3500 (camonsertib) alone or in combination with talazoparib or gemcitabine
Identify anti-tumor activity associated with RP-3500 (camonsertib) given alone or in combination with talazoparib or gemcitabine

The initial cohorts will test RP-3500 (camonsertib) as monotherapy. Additional cohorts will enroll with RP-3500 (camonsertib) in combination with talazoparib or gemcitabine.

After the RP2D and schedule is determined, expansion cohort(s) for RP-3500 (camonsertib) will be enrolled to study the anti-tumor effect, and further examine the safety and PK of RP-3500 (camonsertib) at the RP2D

Conditions: Advanced Solid Tumor
Being tested: RP-3500 (camonsertib), Talazoparib, Gemcitabine Injection
Keywords: Adult

What participants receive

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

RP-3500 (camonsertib)Drug
Oral ATR inhibitor
TalazoparibDrug
Oral PARP inhibitor
Gemcitabine InjectionDrug
Gemcitabine

Study groups in NCT04497116
Study group	Role	What they receive
RP-3500 (camonsertib) alone	Experimental	Phase 1: Multiple doses of RP-3500 (camonsertib) for oral administration alone Receives: Drug: RP-3500 (camonsertib)
Expansion cohorts with RP-3500 (camonsertib)	Experimental	Phase 2: Expansion cohorts with RP-3500 (camonsertib) Receives: Drug: RP-3500 (camonsertib)
RP-3500 (camonsertib) with Talazoparib or Gemcitabine	Experimental	Phase 1: Multiple doses of RP-3500 (camonsertib) for oral administration in combination with talazoparib or gemcitabine Receives: Drug: RP-3500 (camonsertib); Drug: Talazoparib; Drug: Gemcitabine Injection

What is being measured

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

Frequency of Treatment-Related Adverse Event of CTCAE Grade 3 and Above
Treatment-emergent adverse events (TEAEs) are those events that occur or worsen on or after the first dose of study drug up through 30 days post the last dose (or cross over to a different module) or the start of subsequent anticancer therapy. AEs are considered related to treatment if the relationship to camonsertib or the other combination drug (in the study regimen) is "Related" (include unknown relationship) as indicated on the AE eCRF page based on investigator's assessment.
Measured: Start of treatment to 30 days post last dose, up to 1 year
Frequency of Dose Limiting Toxicity (DLT)
Toxicity were assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. A toxicity was considered dose-limiting if it occurred during the first cycle and was deemed at least possibly related to study treatment. If multiple toxicities occurred, the most severe toxicity was used in the assessment. The DLT Evaluable population consists of patients who received at least 80% of planned total doses of camonsertib , 80% of planned total doses of camonsertib and talazoparib, or 80% of planned total doses of camonsertib and 100% of gemcitabine; complete all required safety evaluations and are observed through the end of Cycle 1; or patients who experience a DLT qualifying event in the first cycle of treatment.
Measured: Either 21 days or 28 days (1 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.

22 Jul 202013 Jun 2025

First posted4 Aug 2020
Study start22 Jul 2020
Primary completion13 Jun 2025
Study completion13 Jun 2025

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 (2)Papers the sponsor has linked to this study.
Other trials for Advanced Solid TumorStudies 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: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04497116
Sponsor's protocol ID: RP-3500-01
Other IDs: 2020-000301-87
Acronym: TRESR
Status last verified: Oct 2025
First submitted: 21 Jul 2020
Last updated: 21 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Fontana E, Rosen E, Lee EK, Hojgaard M, Mettu NB, Lheureux S, Carneiro BA, Cote GM, Carter L, Plummer R, Mahalingam D, Fretland AJ, Schonhoft JD, Silverman IM, Wainszelbaum M, Xu Y, Ulanet D, Koehler M, Yap TA. Ataxia telangiectasia and Rad3-related (ATR) inhibitor camonsertib dose optimization in patients with biomarker-selected advanced solid tumors (TRESR study). J Natl Cancer Inst. 2024 Sep 1;116(9):1439-1449. doi: 10.1093/jnci/djae098.
PubMed 38710487
Yap TA, Fontana E, Lee EK, Spigel DR, Hojgaard M, Lheureux S, Mettu NB, Carneiro BA, Carter L, Plummer R, Cote GM, Meric-Bernstam F, O'Connell J, Schonhoft JD, Wainszelbaum M, Fretland AJ, Manley P, Xu Y, Ulanet D, Rimkunas V, Zinda M, Koehler M, Silverman IM, Reis-Filho JS, Rosen E. Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results. Nat Med. 2023 Jun;29(6):1400-1411. doi: 10.1038/s41591-023-02399-0. Epub 2023 Jun 5.
PubMed 37277454

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

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination With Talazoparib or Gemcitabine in Advanced Solid Tumors With ATR Inhibitor Sensitizing Mutations (TRESR Study)
ClinicalTrials.gov ID: NCT04497116
Acronym / sponsor ID: TRESR / RP-3500-01
Conditions: Advanced Solid Tumor
Keywords: Adult
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: Repare TherapeuticsIndustry (pharma, biotech, devices)
Study start: 22 Jul 2020 (actual)
Primary completion: 13 Jun 2025 (actual)
Study completion: 13 Jun 2025 (actual)
First posted: 4 Aug 2020 (actual)
Results: Posted 21 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 1/2a, multi-center, open-label, dose-escalation and expansion study to:

Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally, alone and in combination with talazoparib or gemcitabine, to establish the dose and schedule recommended for the Phase 2
Characterize the PK profile of RP-3500 (camonsertib) alone or in combination with talazoparib or gemcitabine
Identify anti-tumor activity associated with RP-3500 (camonsertib) given alone or in combination with talazoparib or gemcitabine

The initial cohorts will test RP-3500 (camonsertib) as monotherapy. Additional cohorts will enroll with RP-3500 (camonsertib) in combination with talazoparib or gemcitabine.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: Dose Escalation, expansion and phase 2

Arm	Type	Receives
RP-3500 (camonsertib) alone	Experimental	Drug: RP-3500 (camonsertib)Phase 1: Multiple doses of RP-3500 (camonsertib) for oral administration alone
Expansion cohorts with RP-3500 (camonsertib)	Experimental	Drug: RP-3500 (camonsertib)Phase 2: Expansion cohorts with RP-3500 (camonsertib)
RP-3500 (camonsertib) with Talazoparib or Gemcitabine	Experimental	Drug: RP-3500 (camonsertib), Drug: Talazoparib, Drug: Gemcitabine InjectionPhase 1: Multiple doses of RP-3500 (camonsertib) for oral administration in combination with talazoparib or gemcitabine

Who may qualify

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

Key inclusion criteria (16 listed)

Written informed consent, according to local guidelines, signed and dated by the patient or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses.
Male or female and ≥ 18 years-of-age at the time of signature of the consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Histologically confirmed solid tumors resistant or refractory to standard treatment and/or patients who are intolerant to standard therapy.
Measurable disease as per RECIST v1.1

Key exclusion criteria (14 listed)

Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 14 days prior to first dose of study drug.
History or current condition (such as transfusion dependent anemia or thrombocytopenia), 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.
Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.
Known hypersensitivity to any of the ingredients of RP-3500 (camonsertib).
Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the patient's safety.

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)Oral ATR inhibitor	Drug	Expansion cohorts with RP-3500 (camonsertib), RP-3500 (camonsertib) alone, RP-3500 (camonsertib) with Talazoparib or Gemcitabine
TalazoparibOral PARP inhibitor	Drug	RP-3500 (camonsertib) with Talazoparib or Gemcitabine
Gemcitabine InjectionGemcitabine	Drug	RP-3500 (camonsertib) with Talazoparib or Gemcitabine

Primary outcome

Frequency of Treatment-Related Adverse Event of CTCAE Grade 3 and Above
Time frame: Start of treatment to 30 days post last dose, up to 1 year
Treatment-emergent adverse events (TEAEs) are those events that occur or worsen on or after the first dose of study drug up through 30 days post the last dose (or cross over to a different module) or the start of subsequent anticancer therapy. AEs are considered related to treatment if the relationship to camonsertib or the other combination drug (in the study regimen) is "Related" (include unknown relationship) as indicated on the AE eCRF page based on investigator's assessment.
Frequency of Dose Limiting Toxicity (DLT)
Time frame: Either 21 days or 28 days (1 cycle) from the initiation of the study treatment.
Toxicity were assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. A toxicity was considered dose-limiting if it occurred during the first cycle and was deemed at least possibly related to study treatment. If multiple toxicities occurred, the most severe toxicity was used in the assessment. The DLT Evaluable population consists of patients who received at least 80% of planned total doses of camonsertib , 80% of planned total doses of camonsertib and talazoparib, or 80% of planned total doses of camonsertib and 100% of gemcitabine; complete all required safety evaluations and are observed through the end of Cycle 1; or patients who experience a DLT qualifying event in the first cycle of treatment.

Results and safety

Results posted to the registry on 21 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
Cam<=80 5/2	7	1
Cam100 5/2	8	3
Cam120 5/2	6	3
Cam160 5/2	3	1
Cam80BID 5/2	1	0
Cam40BID 3/4	1	0
Cam60BID 3/4	4	0
Cam120 3/4	25	5
Cam160 3/4	67	13
Cam160 2/1w	30	8
Cam200 2/1w	5	0
Tala0.5+Cam25	2	1
Tala0.25+Cam25	3	1
Tala0.25+Cam50	6	3
Tala0.25+Cam80	32	7
Gem400+Cam80 2/1	5	1
Gem600+Cam80	6	1
Gem800+Cam80	2	0
Gem1000+Cam80	5	0
Gem400+Cam80 1/1w	28	5
Gem400+Cam80 2/5	3	0
Gem100+Cam120	2	0
Gem100+Cam80mg	6	0
Gem200+Cam80 2/1w	12	2
Gem200+Cam80 1/1w	7	0

Primary outcome: Frequency of Treatment-Related Adverse Event of CTCAE Grade 3 and Above

Time frame: Start of treatment to 30 days post last dose, up to 1 year. Count of participants. Unit: Participants

Measure	Cam<=80 5/2 n = 7	Cam100 5/2 n = 8	Cam120 5/2 n = 6	Cam160 5/2 n = 3	Cam80BID 5/2 n = 1	Cam40BID 3/4 n = 1	Cam60BID 3/4 n = 4	Cam120 3/4 n = 25	Cam160 3/4 n = 67	Cam160 2/1w n = 30	Cam200 2/1w n = 5	Tala0.5+Cam25 n = 2	Tala0.25+Cam25 n = 3	Tala0.25+Cam50 n = 6	Tala0.25+Cam80 n = 32	Gem400+Cam80 2/1 n = 5	Gem600+Cam80 n = 6	Gem800+Cam80 n = 2	Gem1000+Cam80 n = 5	Gem400+Cam80 1/1w n = 28	Gem400+Cam80 2/5 n = 3	Gem100+Cam120 n = 2	Gem100+Cam80mg n = 6	Gem200+Cam80 2/1w n = 12	Gem200+Cam80 1/1w n = 7
Value	2	5	6	2	1	1	3	8	32	8	3	2	3	3	19	5	5	1	5	19	1	1	6	9	4

Primary outcome: Frequency of Dose Limiting Toxicity (DLT)

Time frame: Either 21 days or 28 days (1 cycle) from the initiation of the study treatment.. Count of participants. Unit: Participants

Measure	Cam<=80 5/2 n = 6	Cam100 5/2 n = 4	Cam120 5/2 n = 4	Cam160 5/2 n = 3	Cam80BID 5/2 n = 0	Cam40BID 3/4 n = 0	Cam60BID 3/4 n = 3	Cam120 3/4 n = 16	Cam160 3/4 n = 38	Cam160 2/1w n = 26	Cam200 2/1w n = 5	Tala0.5+Cam25 n = 2	Tala0.25+Cam25 n = 3	Tala0.25+Cam50 n = 6	Tala0.25+Cam80 n = 25	Gem400+Cam80 2/1 n = 5	Gem600+Cam80 n = 2	Gem800+Cam80 n = 0	Gem1000+Cam80 n = 3	Gem400+Cam80 1/1w n = 26	Gem400+Cam80 2/5 n = 3	Gem100+Cam120 n = 2	Gem100+Cam80mg n = 6	Gem200+Cam80 2/1w n = 9	Gem200+Cam80 1/1w n = 7
Value	0	2	0	0	0	0	1	2	3	2	1	2	1	0	6	5	1	0	2	7	2	1	2	3	0

Population analysed: Rate of DLT among DLT-evaluable population. DLT-evaluable population consists of patients who: * Experience a DLT event or * Received at least 80% of planned total doses of RP-3500 during Cycle 1 (Module 1), both RP-3500 and talazoparib (Module 3), or 80% of RP-3500 and 100% of gemcitabine (Module 4), complete all required safety evaluations, and are observed through the end of Cycle 1

Adverse events

Time frame: Up to 4.5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cam<=80 5/2	1 of 7 (14.3%)	6 of 7 (85.7%)	4 of 7
Cam100 5/2	4 of 8 (50%)	8 of 8 (100%)	7 of 8
Cam120 5/2	3 of 6 (50%)	6 of 6 (100%)	3 of 6
Cam160 5/2	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Cam80BID 5/2	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Cam40BID 3/4	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Cam60BID 3/4	1 of 4 (25%)	4 of 4 (100%)	3 of 4
Cam120 3/4	5 of 25 (20%)	23 of 25 (92%)	10 of 25
Cam160 3/4	20 of 67 (29.9%)	65 of 67 (97%)	41 of 67
Cam160 2/1w	9 of 30 (30%)	29 of 30 (96.7%)	16 of 30
Cam200 2/1w	2 of 5 (40%)	5 of 5 (100%)	3 of 5
Tala0.5+Cam25	1 of 2 (50%)	2 of 2 (100%)	1 of 2
Tala0.25+Cam25	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Tala0.25+Cam50	1 of 6 (16.7%)	6 of 6 (100%)	3 of 6
Tala0.25+Cam80	11 of 32 (34.4%)	32 of 32 (100%)	18 of 32
Gem400+Cam80 2/1	2 of 5 (40%)	5 of 5 (100%)	3 of 5
Gem600+Cam80	4 of 6 (66.7%)	6 of 6 (100%)	2 of 6
Gem800+Cam80	1 of 2 (50%)	2 of 2 (100%)	1 of 2
Gem1000+Cam80	2 of 5 (40%)	5 of 5 (100%)	4 of 5
Gem400+Cam80 1/1w	10 of 28 (35.7%)	28 of 28 (100%)	17 of 28
Gem400+Cam80 2/5	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3

Limitations and caveats (from the sponsor): No Module 5 (pediatric cohort) study activities were initiated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38710487Fontana E, Rosen E, Lee EK, Hojgaard M, Mettu NB, Lheureux S, Carneiro BA, Cote GM, Carter L, Plummer R, Mahalingam D, Fretland AJ, Schonhoft JD, Silverman IM, Wainszelbaum M, Xu Y, Ulanet D, Koehler M, Yap TA. Ataxia telangiectasia and Rad3-related (ATR) inhibitor camonsertib dose optimization in patients with biomarker-selected advanced solid tumors (TRESR study). J Natl Cancer Inst. 2024 Sep 1;116(9):1439-1449. doi: 10.1093/jnci/djae098.
Derived from this study: PubMed 37277454Yap TA, Fontana E, Lee EK, Spigel DR, Hojgaard M, Lheureux S, Mettu NB, Carneiro BA, Carter L, Plummer R, Cote GM, Meric-Bernstam F, O'Connell J, Schonhoft JD, Wainszelbaum M, Fretland AJ, Manley P, Xu Y, Ulanet D, Rimkunas V, Zinda M, Koehler M, Silverman IM, Reis-Filho JS, Rosen E. Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results. Nat Med. 2023 Jun;29(6):1400-1411. doi: 10.1038/s41591-023-02399-0. Epub 2023 Jun 5.
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.

Timothy A Yap, MBBS PhD FRCP principal investigator

M.D. Anderson Cancer Center

13 sites in 4 countries: 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), Talazoparib and Gemcitabine Injection in people with Advanced Solid Tumor, run by Repare Therapeutics at 13 sites in 4 countries.

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 16 inclusion and 14 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: finished, as of the sponsor's last update on 21 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, United Kingdom, Canada, Denmark. 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 21 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?

Frequency of Treatment-Related Adverse Event of CTCAE Grade 3 and Above (time frame: Start of treatment to 30 days post last dose, up to 1 year). 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 NCT04497116, which also lists 2 linked publications.

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 21 Oct 2025.