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Phase I

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

  • Study HIC#:2000030903
  • Last Updated:01/01/0001

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.

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    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

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    Trial Purpose and 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).

    Eligibility Criteria

    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.
    • Measurable 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.

    Principal Investigator

    For more information about this study, including how to volunteer, contact: