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Recruiting NCT06586515

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

Phase I Interventional Pancreatic Ductal Adenocarcinoma Non-small Cell Lung Cancer Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY3962673, Cetuximab, Gemcitabine, nab-paclitaxel.
Who it may be relevant to
Registry conditions: Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, China, France, Germany +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug LY3962673
    Administered orally.
  • Drug Cetuximab
    Administered intravenously.
  • Drug Gemcitabine
    Administered intravenously.
  • Drug nab-paclitaxel
    Administered intravenously.
  • Drug Oxaliplatin
    Administered intravenously.
  • Drug leucovorin
    Administered intravenously.
  • Drug Irinotecan
    Administered intravenously.
  • Drug 5-fluorouracil
    Administered intravenously.

Primary outcome measures

  • 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]
  • Phase 1a: Number of Participants with DLT [Time frame: During the first 28-day cycle of LY3962673 treatment]
  • Phase 1a: Number of Participants with DLT Equivalent Toxicities [Time frame: During the first 28-day cycle of LY3962673 treatment]
  • Phase 1b: Overall Response Rate (ORR) [Time frame: Up to approximately 5 years]
  • Phase 1b: Best Overall Response (BOR) [Time frame: Up to approximately 5 years]
  • Phase 1b: Duration of Response (DOR) [Time frame: Up to approximately 5 years]
  • Phase 1b: Time to Response (TTR) [Time frame: Up to approximately 5 years]
  • Phase 1b: Disease Control Rate (DCR) [Time frame: Up to approximately 5 years]
Secondary outcome measures (8)
  • Phase 1a: Overall Response Rate (ORR) [Time frame: Up to approximately 5 years]
  • Best Overall Response (BOR) [Time frame: Up to approximately 5 years]
  • Duration of Response (DOR) [Time frame: Up to approximately 5 years]
  • Time to Response (TTR) [Time frame: Up to approximately 5 years]
  • Disease Control Rate (DCR) [Time frame: Up to approximately 5 years]
  • Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3962673 [Time frame: Predose through Day 168]
  • PK: Time to Maximum Concentration (Tmax) of LY3962673 [Time frame: Predose through Day 168]
  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY3962673 [Time frame: Predose through Day 168]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 25 centers
  • City of Hope — Duarte
  • University of California, Los Angeles (UCLA) — Santa Monica
  • Sarah Cannon Research Institute at HealthOne — Denver
  • Sibley Memorial Hospital — Washington D.C.
  • Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute — Orlando
  • Emory University School of Medicine — Atlanta
  • Community Health Network — Indianapolis
  • Massachusetts General Hospital — Boston
  • … and 17 more centers
Japan · 5 centers
  • National Cancer Center Hospital East — Chiba
  • Kanagawa cancer center — Kanagawa
  • Aichi Cancer Center Hospital — Nagoya
  • Kansai Medical University Hospital — Osaka
  • National Cancer Center Hospital — Tokyo
China · 4 centers
  • Cancer Institute & Hospital, Chinese Academy of Medical Sciences — Beijing
  • Beijing Cancer hospital — Beijing
  • Harbin Medical University Cancer Hospita — Harbin
  • Fudan University Shanghai Cancer Center — Shanghai
France · 4 centers
  • Centre Leon Berard — Lyon
  • Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone — Marseille
  • Oncopole Claudius Regaud — Toulouse
  • Institut Gustave Roussy — Villejuif
Germany · 4 centers
  • Charite Universitaetsmedizin Berlin — Berlin
  • Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
  • Universitaetsklinikum Essen — Essen
  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen — München
Spain · 4 centers
  • South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos — Barcelona
  • Hospital Universitario Vall d'Hebron — Barcelona
  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez — Madrid
  • Hospital Universitario 12 de Octubre — Madrid
Italy · 3 centers
  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli — Naples
  • UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica — Roma
  • Centro Ricerche Cliniche di Verona s.r.l. — Verona
Canada · 2 centers
  • The Ottawa Hospital — Ottawa
  • Princess Margaret Hospital — Toronto
Ireland · 1 center
  • START Dublin Early Phase Clinical Trials Unit — Dublin

Identifiers

NCT: NCT06586515 · 27189 · J5J-OX-JZZA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗