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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

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT06253130

Intervention or treatment

DRUG: IMP1734

Conditions

• Advanced Solid Tumor

Condition: Advanced Solid Tumor
DRUG: IMP1734
Randwick, New South Wales, Australia and more
Sponsor: Eikon Therapeutics

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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

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/Arm	Intervention/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 Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of subjects with adverse events, treatment emergent adverse events or serious adverse events	Number 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 parameters	Consent to 30 + 7 days post last dose of IMP1734
Maxim Tolerated Dose or Recommended Dose for Expansion	Number 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 Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Pharmacokinetic parameters of IMP1734	Peak plasma concentration (Cmax)	Through study completion, up to 3 years
Pharmacokinetic parameters of IMP1734	Time to peak drug concentration (Tmax)	Through study completion, up to 3 years
Pharmacokinetic parameters of IMP1734	Area under the curve (AUC) will be defined	Through study completion, up to 3 years
Overall Response Rate	Percentage 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 criteria	Through study completion, up to 3 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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