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Phase 1a/1b Study of LY3962673 in Patients with KRAS G12D-Mutant Solid Tumors
Cancer Categories
Gastrointestinal (GI),Lung
Karmanos Trial ID
2024-088
NCT ID
NCT06586515
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
Mohammed Najeeb
Al Hallak, M.D., MS
Oncology - Medical
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Objective:
Primary Objectives:
Phase 1a Primary
To assess the safety and tolerability of LY3962673 monotherapy
Phase 1a Secondary
To assess the antitumor activity of LY3962673 monotherapy
To characterize the PK properties of LY3962673 monotherapy
Phase 1b Primary
Dose Expansion: To assess the antitumor activity of LY3962673
Dose Optimization: To confirm the RP2D/optimal dose based on safety and efficacy of LY3962673
Phase 1b Secondary
Dose Expansion: To assess the safety and tolerability of LY3962673
Dose Expansion: To assess, for each Dose Expansion cohort, the antitumor activity per RECIST v1.1
All Cohorts: To characterize the PK properties of LY3962673
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Have Histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
Have an ECOG performance status of ≤ 1
Must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease
Participants with asymptomatic or treated CNS disease may be eligible.
Exclusion Criteria:
Have known active CNS metastases and/or carcinomatous meningitis.
Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.
Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction.
Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Colon; Lung; Pancreas
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Chemotherapy
Drugs
Cetuximab; FOLFIRINOX; Gemcitabine; LY3962673; Nab-paclitaxel
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