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Pancreatic Ductal AdenocarcinomaPhase 1MOONRAY-01NCT06586515

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

A Phase 1 study testing LY3962673, Cetuximab and Gemcitabine in people with Pancreatic Ductal Adenocarcinoma and Non-small Cell Lung Cancer, run by Eli Lilly and Company at 52 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LY3962673, Cetuximab and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
52 sitesin 9 countries
Study dates
12 Sep 2024to Mar 2028
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

52 sites in 9 countries.

52 sites in 9 countries

United States25 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Cincinnati (UC) - Cancer Institute

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Sarah Cannon Research Institute at HealthOne

    Denver, Colorado, 80218

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • South Texas Accelerated Research Therapeutics (START) Midwest

    Grand Rapids, Michigan, 49546

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Community Health Network

    Indianapolis, Indiana, 46250

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • USO - US Oncology Research Network

    Nashville, Tennessee, 37203

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37215

  • New York University (NYU) Langone Medical Center

    New York, New York, 10016

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute

    Orlando, Florida, 32827

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229

  • University of California, Los Angeles (UCLA)

    Santa Monica, California, 90404

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

Other trials in United States

Japan5 sites

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Kanagawa cancer center

    Kanagawa, 241-8515

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681

  • Kansai Medical University Hospital

    Osaka, 573-1191

  • National Cancer Center Hospital

    Tokyo, 104-0045

Other trials in Japan

China4 sites

  • Cancer Institute & Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Beijing Cancer hospital

    Beijing, 100142

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

France4 sites

  • Centre Leon Berard

    Lyon, 69373

  • Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone

    Marseille, 13005

  • Oncopole Claudius Regaud

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany4 sites

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitaetsklinikum Essen

    Essen, 45147

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    München, 81377

Other trials in Germany

Spain4 sites

  • South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos

    Barcelona, 08023

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

Italy3 sites

  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli

    Naples, 80138

  • UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Roma, 00168

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134

Other trials in Italy

Canada2 sites

  • The Ottawa Hospital

    Ottawa, K1H 8L6

  • Princess Margaret Hospital

    Toronto, M5G 2M9

Other trials in Canada

Ireland1 site

  • START Dublin Early Phase Clinical Trials Unit

    Dublin, D07 R2WY

Other trials in Ireland

About this study

Official title: A Phase 1a/1b Trial 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.

Keywords
KRAS G12D, KRAS, LY3962673, Cetuximab, nab-paclitaxel, Gemcitabine, Oxaliplatin, Leucovorin, Irinotecan, 5-fluorouracil
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3962673Drug

    Administered orally.

  • CetuximabDrug

    Administered intravenously.

  • GemcitabineDrug

    Administered intravenously.

  • nab-paclitaxelDrug

    Administered intravenously.

  • OxaliplatinDrug

    Administered intravenously.

  • leucovorinDrug

    Administered intravenously.

  • IrinotecanDrug

    Administered intravenously.

  • 5-fluorouracilDrug

    Administered intravenously.

Study groups in NCT06586515
Study groupRoleWhat they receive
Phase 1a: LY3962673 Dose EscalationExperimentalEscalating doses of LY3962673 administered orally.
Receives: Drug: LY3962673
Phase 1b: LY3962673 Dose ExpansionExperimentalLY3962673 administered orally either alone or in combination with other chemotherapy agents.
Receives: Drug: LY3962673; Drug: Cetuximab; Drug: Gemcitabine; Drug: nab-paclitaxel; Drug: Oxaliplatin; Drug: leucovorin; Drug: Irinotecan; Drug: 5-fluorouracil
Experimental: Phase 1a: LY3962673 MonotherapyExperimentalLY3962673 administered orally
Receives: Drug: LY3962673

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline through 5 years

  2. Phase 1a: Number of Participants with DLT

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

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

    Measured: 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)

    Measured: Up to approximately 5 years

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

    BOR per investigator assessed RECIST 1.1

    Measured: Up to approximately 5 years

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

    DOR per investigator assessed RECIST 1.1

    Measured: Up to approximately 5 years

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

    TTR per investigator assessed RECIST 1.1

    Measured: Up to approximately 5 years

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

    DCR per investigator assessed RECIST 1.1

    Measured: Up to approximately 5 years

Secondary outcomes (8)

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

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

    Measured: Up to approximately 5 years

  2. Best Overall Response (BOR)

    BOR per investigator assessed RECIST 1.1

    Measured: Up to approximately 5 years

  3. Duration of Response (DOR)

    DOR per investigator assessed RECIST 1.1

    Measured: Up to approximately 5 years

  4. Time to Response (TTR)

    TTR per investigator assessed RECIST 1.1

    Measured: Up to approximately 5 years

  5. Disease Control Rate (DCR)

    DCR per investigator assessed RECIST 1.1

    Measured: Up to approximately 5 years

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

    PK: Cmax of LY3962673

    Measured: Predose through Day 168

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

    PK: Tmax of LY3962673

    Measured: Predose through Day 168

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

    PK: AUC of LY3962673

    Measured: Predose through Day 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start12 Sep 2024
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Phase 1a/1b
Masking
None (open label)
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06586515
Sponsor's protocol ID
27189
Other IDs
J5J-OX-JZZA
Acronym
MOONRAY-01
Status last verified
Oct 2026
First submitted
4 Sep 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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