A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors

PHASE1PHASE2RECRUITING

This study will evaluate the preliminary efficacy of IMP1734 in patients with recurrent advanced/metastatic breast cancer, ovarian cancer and metastatic castrate resistant prostate cancer (mCRPC) with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.

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Study details:

This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. The study consists of 3 parts: Dose escalation, Dose Optimization and Dose expansion. In dose escalation (Part1), the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor.

In dose optimization (Part 2), the study will further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of IMP1734. In dose expansion (Part 3) the recommended dose escalation (RDE) of IMP1734 monotherapy will be evaluated in patients with recurrent, advanced/metastatic breast cancer, ovarian cancer and mCRPC with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) gene mutations.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Breast cancer; must have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if HR+
  • HGSOC or high grade endometrioid EOC, fallopian tube or primary peritoneal cancer; must have received at least one prior platinum-based chemotherapy for advanced disease
  • mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy
  • Age ≥ 18 years at the time of informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Adequate organ function
  • Life expectancy ≥ 12 weeks
  • Should have evaluable disease as defined by RECIST1.1 and/or CA125 or PSA
  • Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception from study entry up to 6 months after the last dose of IMP1734
  • deleterious or suspected deleterious germline or somatic mutations of select HRR genes
  • up to 1 prior line of PARP inhibitor containing treatment
  • Exclusion criteria

  • Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of IMP1734
  • Have received prior PARP1 selective inhibitors
  • Mean resting QTcF > 470 ms or QTcF < 340 ms
  • Active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Infections
  • An active hepatitis B/C infection
  • Any known predisposition to bleeding
  • Unable to swallow oral medications OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-12-11

    Primary completion: 2026-02-01

    Study completion finish: 2026-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT06253130

    Intervention or treatment

    DRUG: IMP1734

    Conditions

    • Advanced Solid Tumor

    Find a site

    Closest Location:

    Scientia Clinical Research Ltd

    Research sites nearby

    Select from list below to view details:

    • Scientia Clinical Research Ltd

      Randwick, New South Wales, Australia

    • Princess Alexandra Hospital

      Woolloongabba, Queensland, Australia

    • Mater Cancer Care Centre, Mater Misericordiae Limited

      South Brisbane, Queensland, Australia

    • Gold Coast Private Hospital

      Southport, Queensland, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Cohort 1
    • IMP1734 monotherapy; oral tablet(s) daily (except for the single-dose period). The maximum trial duration is 3 years after the last participant's first treatment in the trial.
    DRUG: IMP1734
    • PARP1 selective inhibitor

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Number of subjects with adverse events, treatment emergent adverse events or serious adverse eventsNumber of subjects reporting adverse events or serious adverse events which include any abnormal clinical events, laboratory assessments outside of normal clinical range, abnormal vital signs observed, and any abnormal ECG parametersConsent to 30 + 7 days post last dose of IMP1734
    Maxim Tolerated Dose or Recommended Dose for ExpansionNumber of patients that experience a DLT or any toxicity which occurs from the time of the first dose of study drug until the end of cycle 1, which is deemed unrelated to the disease.DLT period is from the first dose of the study drug until the last day of the first cycle

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Pharmacokinetic parameters of IMP1734Peak plasma concentration (Cmax)Through study completion, up to 3 years
    Pharmacokinetic parameters of IMP1734Time to peak drug concentration (Tmax)Through study completion, up to 3 years
    Pharmacokinetic parameters of IMP1734Area under the curve (AUC) will be definedThrough study completion, up to 3 years
    Overall Response RatePercentage of participants who have CR/PR per RECIST v1.1,and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteriaThrough study completion, up to 3 years

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    References

    Clinical Trials Gov: A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors

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