Ovarian Cancer Clinical Trial

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

Summary

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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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Key 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 HHR genes
up to 1 prior line of PARP inhibitor containing treatment

Key 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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT06253130

Recruitment Status:

Recruiting

Sponsor:

Eikon Therapeutics

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There are 11 Locations for this study

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Sarah Cannon Research Institute Health One
Denver Colorado, 80218, United States More Info
Alissa Snow
Contact
[email protected]
Gerald Falchook, MD
Principal Investigator
Advent Health Research Institute
Celebration Florida, 34747, United States More Info
Charmaine Garcia
Contact
[email protected]
Sonpavde Guru, MD
Principal Investigator
Sarah Cannon Research Institue Oncology
Nashville Tennessee, 37203, United States More Info
Tallia Popwycz
Contact
[email protected]
Benjamin Garmezy, MD
Principal Investigator
START - South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States More Info
Jacquelin Cervantes
Contact
[email protected]
Drew Rasco, MD
Principal Investigator
START Mountain Region
West Valley City Utah, 84119, United States More Info
Marianne Herndon
Contact
[email protected]
Justin Call, MD
Principal Investigator
Scientia Clinical Research Ltd
Randwick New South Wales, 2031, Australia More Info
Grace Hwang
Contact
[email protected]
Christina Teng
Principal Investigator
Mater Cancer Care Centre, Mater Misericordiae Limited
South Brisbane Queensland, 4101, Australia More Info
Hanumasri Matturi
Contact
[email protected]
Catherine Shannon
Principal Investigator
Gold Coast Private Hospital
Southport Queensland, 4125, Australia More Info
Michelle Cestari
Contact
Andrea Tazbirkova
Principal Investigator
Macquarie University
Sydney Queensland, 2109, Australia More Info
Jacqui Delahunt Smoleniec
Contact
[email protected]
Dhanusha Sabanathan
Principal Investigator
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia More Info
Jillian Hung
Contact
Wen Xu
Principal Investigator
Peninsula and south eastern haematology and oncology group
Frankston Victoria, 3199, Australia More Info
Henry Gordon
Contact
[email protected]
Vinod Ganju
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT06253130

Recruitment Status:

Recruiting

Sponsor:


Eikon Therapeutics

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