A first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, IMP1734, in patients with advanced solid tumors

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Part 1 and Part 2

Primary Objectives:

To evaluate the safety and tolerability of IMP1734 as monotherapy and in combination with anti-cancer agents
To determine the MTD (or MAD) and RDE as monotherapy and in combination with anti-cancer
agents

Secondary Objectives:

To characterize the plasma PK profile of single and multiple doses of IMP1734
To assess preliminary anti-tumor activity of IMP1734 as monotherapy and in combination with anti-cancer agents

Part 3

Primary Objectives:

Secondary Objectives:

Eligibility

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices