MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

NCT06586515
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
630
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Lead sponsor
Eli Lilly and Company
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Start date
2024-09-12
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Number of sites
52
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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.
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Acronym
MOONRAY-01
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Short title
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
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Official title
A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-03-01
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First posted
2024-09-19
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Registry last updated
2026-08-24
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Primary completion date
2029-03-01
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Start date
2024-09-12
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Participants
630
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Participant count basis
Estimated
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Planned participants
630
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Protocol amendments
6
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Number of sites
52
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06586515
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ClinicalTrials.gov ID
NCT06586515
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Timeframe: Baseline through 5 years

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

  2. Phase 1a: Number of Participants with DLT

    Timeframe: During the first 28-day cycle of LY3962673 treatment

  3. Phase 1a: Number of Participants with DLT Equivalent Toxicities

    Timeframe: During the first 28-day cycle of LY3962673 treatment

  4. Phase 1b: Overall Response Rate (ORR)

    Timeframe: Up to approximately 5 years

    ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  5. Phase 1b: Best Overall Response (BOR)

    Timeframe: Up to approximately 5 years

    BOR per investigator assessed RECIST 1.1

  6. Phase 1b: Duration of Response (DOR)

    Timeframe: Up to approximately 5 years

    DOR per investigator assessed RECIST 1.1

  7. Phase 1b: Time to Response (TTR)

    Timeframe: Up to approximately 5 years

    TTR per investigator assessed RECIST 1.1

  8. Phase 1b: Disease Control Rate (DCR)

    Timeframe: Up to approximately 5 years

    DCR per investigator assessed RECIST 1.1

  1. Phase 1a: Overall Response Rate (ORR)

    Timeframe: Up to approximately 5 years

    ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  2. Best Overall Response (BOR)

    Timeframe: Up to approximately 5 years

    BOR per investigator assessed RECIST 1.1

  3. Duration of Response (DOR)

    Timeframe: Up to approximately 5 years

    DOR per investigator assessed RECIST 1.1

  4. Time to Response (TTR)

    Timeframe: Up to approximately 5 years

    TTR per investigator assessed RECIST 1.1

  5. Disease Control Rate (DCR)

    Timeframe: Up to approximately 5 years

    DCR per investigator assessed RECIST 1.1

  6. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3962673

    Timeframe: Predose through Day 168

    PK: Cmax of LY3962673

  7. PK: Time to Maximum Concentration (Tmax) of LY3962673

    Timeframe: Predose through Day 168

    PK: Tmax of LY3962673

  8. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3962673

    Timeframe: Predose through Day 168

    PK: AUC of LY3962673

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • City of HopeDuarte, United StatesRecruiting
  • University of California, Los Angeles (UCLA)Santa Monica, United StatesRecruiting
  • Sarah Cannon Research Institute at HealthOneDenver, United StatesRecruiting
  • Sibley Memorial HospitalWashington D.C., United StatesRecruiting
  • Florida Cancer Specialists - Lake Nona - Sarah Cannon Research InstituteOrlando, United StatesRecruiting
  • Emory University School of MedicineAtlanta, United StatesRecruiting
  • Community Health NetworkIndianapolis, United StatesRecruiting
  • Massachusetts General HospitalBoston, United StatesNot yet recruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • Barbara Ann Karmanos Cancer InstituteDetroit, United StatesRecruiting
  • South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, United StatesRecruiting
  • New York University (NYU) Langone Medical CenterNew York, United StatesRecruiting
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Duke University Medical CenterDurham, United StatesRecruiting
  • University of Cincinnati (UC) - Cancer InstituteCincinnati, United StatesRecruiting
  • Cleveland ClinicCleveland, United StatesRecruiting
  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterPittsburgh, United StatesRecruiting
  • Sarah Cannon Research InstituteNashville, United StatesRecruiting
  • USO - US Oncology Research NetworkNashville, United StatesRecruiting
  • Vanderbilt University School of MedicineNashville, United StatesRecruiting
  • MD Anderson Cancer CenterHouston, United StatesRecruiting
  • South Texas Accelerated Research Therapeutics (START)San Antonio, United StatesRecruiting
  • Huntsman Cancer InstituteSalt Lake City, United StatesRecruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting
  • University of Wisconsin - Carbone Cancer CenterMadison, United StatesRecruiting

And 27 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J5J-OX-JZZA
Sources for references
clinicaltrials.gov

Related records

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Lead sponsors (1)

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Targets (32)