About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • LY3962673
  • Cetuximab
  • Gemcitabine
  • nab-paclitaxel
  • Oxaliplatin
  • leucovorin
  • Irinotecan
  • 5-fluorouracil

Treatment groups

630 Participants
are divided into 3 treatment groups

Locations

52
Canada
The Ottawa HospitalK1H 8L6, Ottawa Canada
Princess Margaret HospitalM5G 2M9, Toronto Canada
China
Beijing Cancer hospital100142, Beijing China
Cancer Institute & Hospital, Chinese Academy of Medical Sciences100021, Beijing China

Sponsors and collaborators

Eli Lilly and Company

Lead sponsor