Recruiting
Phase 1

LY3962673

Sponsor:

Eli Lilly and Company

Code:

NCT06586515

Conditions

Pancreatic Ductal Adenocarcinoma

Non-small Cell Lung Cancer

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LY3962673

Cetuximab

Gemcitabine

nab-paclitaxel

Oxaliplatin

Study Details

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Non-small Cell Lung Cancer

Colorectal Cancer

Study ID

NCT06586515

Start date

Sep 12, 2024

Status verified date

Aug, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

630 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: LY3962673 Dose Escalation

Escalating doses of LY3962673 administered orally.

experimental: Phase 1b: LY3962673 Dose Expansion

LY3962673 administered orally either alone or in combination with other chemotherapy agents.

experimental: Experimental: Phase 1a: LY3962673 Monotherapy

LY3962673 administered orally

Interventions

LY3962673

Administered orally.

Cetuximab

Administered intravenously.

Gemcitabine

Administered intravenously.

nab-paclitaxel

Administered intravenously.

Oxaliplatin

Administered intravenously.

leucovorin

Administered intravenously.

Irinotecan

Administered intravenously.

5-fluorouracil

Administered intravenously.

Primary outcome 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 [ 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 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

University of California, Los Angeles (UCLA)

Recruiting

Santa Monica, California, United States, 90404

Sarah Cannon Research Institute at HealthOne

Recruiting

Denver, Colorado, United States, 80218

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute

Recruiting

Orlando, Florida, United States, 32827

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46250

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Barbara Ann Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

South Texas Accelerated Research Therapeutics (START) Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

New York University (NYU) Langone Medical Center

Recruiting

New York, New York, United States, 10016

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

Recruiting

New York, New York, United States, 10065

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

University of Cincinnati (UC) - Cancer Institute

Recruiting

Cincinnati, Ohio, United States, 45267

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

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

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

USO - US Oncology Research Network

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt University School of Medicine

Recruiting

Nashville, Tennessee, United States, 37215

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

South Texas Accelerated Research Therapeutics (START)

Recruiting

San Antonio, Texas, United States, 78229

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

University of Wisconsin - Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

The Ottawa Hospital

Recruiting

Ottawa, Canada, K1H 8L6

Princess Margaret Hospital

Recruiting

Toronto, Canada, M5G 2M9

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • KRAS G12D
  • KRAS
  • LY3962673
  • Cetuximab
  • nab-paclitaxel
  • Gemcitabine
  • Oxaliplatin
  • Leucovorin
  • Irinotecan
  • 5-fluorouracil

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.