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A Study of PARG Inhibitor IDE161 in Participants with Advanced Solid Tumors
Cancer Categories
Breast,Gynecologic
Karmanos Trial ID
2023-080
NCT ID
NCT05787587
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Jailan
Elayoubi, M.D.
Oncology - Medical
View Profile
Objective:
Primary Objectives:
Part 1 (Dose Escalation): To characterize the
safety and tolerability of IDE161 monotherapy to
determine the MTD/MAD, and/or RDE
Part 2 (Dose Expansion): To further assess the
safety and tolerability of IDE161 monotherapy at
the RDE
Part 2: To evaluate preliminary anti-tumor
activity of IDE161 monotherapy
Secondary Objectives:
Part 1: To evaluate preliminary anti-tumor
activity of IDE161 monotherapy
Part 2: Assess risk/benefit at an IDE161
monotherapy dose and exposure alternative to
the initial expansion dose
Both parts: To characterize the single and
multiple dose PK of IDE161 monotherapy
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Adult participants must be 18 years of age or older
Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
Have documented evidence of genetic alterations conferring homologous recombination deficiency
Participant must have progressed on at least one prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care, or for which the participant has documented intolerance
Exclusion Criteria:
Known primary CNS malignancy
Impairment of GI function or GI disease that may significantly alter the absorption of IDE161
Have active, uncontrolled infection
Clinically significant cardiac abnormalities
Major surgery within 4 weeks prior to enrollment
Radiation therapy within 2 weeks prior to enrollment
Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
Radioimmunotherapy within 6 weeks of enrollment
Treatment with a therapeutic antibody within 4 weeks prior to enrollment
Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Breast; Ovary
Therapies, Drugs, Devices
Therapies | Drugs | Devices
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