MOONRAY-01, A Phase 1a/1b Trial of LY3962673 in Participants with KRAS G12D-Mutant Solid Tumors (J5J-OX-JZZA)
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
I
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
Sibley Memorial Hospital
5255 Loughboro Road, N.W., Washington, D.C., 20016
Contact Us
(410) 955-8964Brief Summary
The main purpose of this study is to assess safety & tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.
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).
- Have other active malignancy unless in remission with life expectancy greater than (>) 2 years.