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

R

Repare Therapeutics

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Advanced Solid Tumor, Adult

Treatments

Drug: RP-3500 (camonsertib)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04972110
RP-3500-03

Details and patient eligibility

About

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.

Full 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).

Enrollment

196 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

196 participants in 2 patient groups

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

Trial contacts and locations

13

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Central trial contact

Gabriela Gomez, MD, MBA; Paul Basciano, MD

Data sourced from clinicaltrials.gov

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