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

Completed · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID: NCT04497116
Run by: Repare Therapeutics
People needed: 276
Starts: 2020-07-22
Expected to finish: 2025-06-13
Last updated by the study team: 2025-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
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.

You may not qualify if…

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.
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.

Where it is running

#1014, Northwestern University — Chicago, Illinois, United States
#1006, Massachusetts General Hospital — Boston, Massachusetts, United States
#1002, Dana Farber Cancer Institute — Boston, Massachusetts, United States
#1004, Memorial Sloan Kettering Cancer Institute — New York, New York, United States
#1005, Duke Cancer Institute — Durham, North Carolina, United States
#1007, Rhode Island Hospital — Providence, Rhode Island, United States
#1003, Sarah Cannon Research Institute — Nashville, Tennessee, United States
#1001, The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
#2001, Princess Margaret Cancer Centre — Toronto, Ontario, Canada
#4001, Copenhagen University Hospital Rigshospitalet - Blegdamsvej — Copenhagen, DK, Denmark
#3003, Sarah Cannon Research Institute — London, United Kingdom
#3001, The Christie NHS Foundation Trust — Manchester, United Kingdom
#3002, Freeman Hospital Newcastle — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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