Health Trials

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

ConditionsPancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

630 Participants
are divided into 3 treatment groups
Group A: Phase 1a: LY3962673 Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1b: LY3962673 Dose ExpansionExperimental treatment 8 interventions
Group C: Experimental: Phase 1a: LY3962673 MonotherapyExperimental treatment 1 intervention

Trial outcomes

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

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

Time frame
Baseline through 5 years
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)

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

Time frame
Up to approximately 5 years

Secondary outcomes

1

Phase 1a: Overall Response Rate (ORR)

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

Time frame
Up to approximately 5 years
2

Best Overall Response (BOR)

BOR per investigator assessed RECIST 1.1

Time frame
Up to approximately 5 years
3

Duration of Response (DOR)

DOR per investigator assessed RECIST 1.1

Time frame
Up to approximately 5 years
4

Time to Response (TTR)

TTR per investigator assessed RECIST 1.1

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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