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NCT Number: NCT06586515

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

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.

Recruiting

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Ottawa Hospital, Ottawa, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3962673

Drug

Administered orally.

Cetuximab

Drug

Administered intravenously.

Gemcitabine

Drug

Administered intravenously.

Nab-paclitaxel

Drug

Administered intravenously.

Oxaliplatin

Drug

Administered intravenously.

Leucovorin

Drug

Administered intravenously.

Irinotecan

Drug

Administered intravenously.

5-fluorouracil

Drug

Administered intravenously.

Primary outcomes

  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

    Time frame: 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

    Time frame: During the first 28-day cycle of LY3962673 treatment

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

    Time frame: During the first 28-day cycle of LY3962673 treatment

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

    Time frame: 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)

    Time frame: Up to approximately 5 years

    BOR per investigator assessed RECIST 1.1

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

    Time frame: Up to approximately 5 years

    DOR per investigator assessed RECIST 1.1

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

    Time frame: Up to approximately 5 years

    TTR per investigator assessed RECIST 1.1

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

    Time frame: Up to approximately 5 years

    DCR per investigator assessed RECIST 1.1

Secondary outcomes

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

    Time frame: 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)

    Time frame: Up to approximately 5 years

    BOR per investigator assessed RECIST 1.1

  3. Duration of Response (DOR)

    Time frame: Up to approximately 5 years

    DOR per investigator assessed RECIST 1.1

  4. Time to Response (TTR)

    Time frame: Up to approximately 5 years

    TTR per investigator assessed RECIST 1.1

  5. Disease Control Rate (DCR)

    Time frame: Up to approximately 5 years

    DCR per investigator assessed RECIST 1.1

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

    Time frame: Predose through Day 168

    PK: Cmax of LY3962673

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

    Time frame: Predose through Day 168

    PK: Tmax of LY3962673

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

    Time frame: Predose through Day 168

    PK: AUC of LY3962673

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Acronym: MOONRAY-01

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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