Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Zev Wainberg (ucla)

Description

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.

Official Title

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

Keywords

Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, KRAS G12D, KRAS, LY3962673, Cetuximab, nab-paclitaxel, Gemcitabine, Oxaliplatin, Leucovorin, Irinotecan, 5-fluorouracil, Adenocarcinoma, Paclitaxel, Fluorouracil

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCLA not yet accepting patients
    Santa Monica California 90404 United States
  • City of Hope Medical Group not yet accepting patients
    South Pasadena California 91030 United States
  • Sarah Cannon Research Institute at HealthOne accepting new patients
    Denver Colorado 80218 United States
  • START San Antonio accepting new patients
    San Antonio Texas 78229 United States

Lead Scientist at University of California Health

  • Zev Wainberg (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 161 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
ID
NCT06586515
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 530 study participants
Last Updated