Clinical trial NCT06586515: MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Official title: A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer
Colorectal Cancer
Keywords: KRAS G12D
KRAS
LY3962673
Cetuximab
nab-paclitaxel
Gemcitabine
Oxaliplatin
Leucovorin
Irinotecan
5-fluorouracil
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1a/1b
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: 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
measure: Phase 1a: Number of Participants with DLT
timeFrame: During the first 28-day cycle of LY3962673 treatment
measure: Phase 1a: Number of Participants with DLT Equivalent Toxicities
timeFrame: During the first 28-day cycle of LY3962673 treatment
measure: Phase 1b: Overall Response Rate (ORR)
timeFrame: Up to approximately 5 years
measure: Phase 1b: Best Overall Response (BOR)
timeFrame: Up to approximately 5 years
measure: Phase 1b: Duration of Response (DOR)
timeFrame: Up to approximately 5 years
measure: Phase 1b: Time to Response (TTR)
timeFrame: Up to approximately 5 years
measure: Phase 1b: Disease Control Rate (DCR)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Phase 1a: Overall Response Rate (ORR)
timeFrame: Up to approximately 5 years
measure: Best Overall Response (BOR)
timeFrame: Up to approximately 5 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 5 years
measure: Time to Response (TTR)
timeFrame: Up to approximately 5 years
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 5 years
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3962673
timeFrame: Predose through Day 168
measure: PK: Time to Maximum Concentration (Tmax) of LY3962673
timeFrame: Predose through Day 168
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3962673
timeFrame: Predose through Day 168
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthOne
state: Colorado
city: Washington DC
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Orlando
country: United States
facility: Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: South Texas Accelerated Research Therapeutics (START) Midwest
state: Michigan
city: New York
country: United States
facility: New York University (NYU) Langone Medical Center
state: New York
city: New York
country: United States
facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati (UC) - Cancer Institute
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: USO - US Oncology Research Network
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics (START)
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin - Carbone Cancer Center
state: Wisconsin
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Beijing
country: China
facility: Cancer Institute & Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Beijing Cancer hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospita
city: Shanghai
country: China
facility: Fudan University Cancer Center
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone
city: Toulouse
country: France
facility: Oncopole Claudius Regaud
city: Villejuif cedex
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Munchen
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen
city: Dublin
country: Ireland
facility: START Dublin Early Phase Clinical Trials Unit
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
city: Roma
country: Italy
facility: UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
city: Verona
country: Italy
facility: Centro Ricerche Cliniche di Verona s.r.l.
city: Kanagawa
country: Japan
facility: Kanagawa cancer center
city: Kashiwa, Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
city: Osaka
country: Japan
facility: Kansai Medical University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Barcelona
country: Spain
facility: South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: