Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

PHASE1PHASE2RECRUITING

This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.

Study details:

This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. This study includes 2 parts: Part 1 and Part 2. Part 1 includes a monotherapy dose escalation of EIK1003 followed by combination dose escalations in metastatic prostate cancer (mPC), ovarian and breast cancer.

Part 1, dose escalation, the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor. Part 2 will explore dose optimization with selection of an optimal dose for future clinical development of EIK1003.

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE1PHASE2

Study 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

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Are you running this trial?

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Research sites nearby

Closest Location:

Scientia Clinical Research Ltd

Select from list below to view details:

Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Mater Cancer Care Centre, Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Gold Coast Private Hospital
Southport, Queensland, Australia
Macquarie University
Sydney, Queensland, Australia

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Who is running the clinical trial?

Eikon Therapeutics

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

What is the study measuring?

Primary Outcome

Measure	Description	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

Measure	Description	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

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

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