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

  • STATUS
    Recruiting
  • End date
    Nov 18, 2023
  • participants needed
    108
  • sponsor
    Repare Therapeutics
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Updated on 7 October 2022
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Summary

The primary purpose of this study is to assess the safety and tolerability of Niraparib or Olaparib in combination with RP-3500, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 in combination with Niraparib or Olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.

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 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 in combination with Niraparib or Olaparib
  • Assess anti-tumor activity associated with RP-3500 in combination with Niraparib or Olaparib
  • Examine biomarker responses and establish a correlation with RP-3500 treatment in combination with Niraparib or Olaparib.

After the RP2D and schedule is determined, expansion cohort(s) for RP-3500 in combination with Niraparib or Olaparib will be enrolled to study the anti-tumor effect, and further examine the safety, PK, and pharmacodynamic (PD).

Details
Condition Advanced Solid Tumor, Adult
Treatment RP-3500
Clinical Study IdentifierNCT04972110
SponsorRepare Therapeutics
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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