A Phase 1a/1b Study of LY3537982 in Patients with KRAS G12C-Mutant Advanced Solid Tumors

G
Greg Durm, MD

Primary Investigator

Administratively Closed
18 years or above
All
Phase 1/2
10 participants needed
2 Locations

Brief description of study

What is the purpose of this study?
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
  • This is an open-label, multicenter Phase 1/2 study to evaluate safety, tolerability, and preliminary efficacy of oral LY3537982 in patients with KRAS G12C-mutant solid tumors.
  • This study will be conducted in 4 parts: Phase 1a dose escalation, Phase 1b dose expansion, Phase 1b dose optimization, and Phase 2. KRAS G12C mutations will be identified through standard of care testing.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Biliary Tract Neoplasms, Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Endometrial Neoplasms. Ovarian Neoplasms, Pancreatic Neoplasms
  • Age: 18 years or above
  • Gender: All

8/15/24 - Closed to accrual
Sent from OnCore on behalf of Morsal Rasouli
OnCore Protocol No.: CTO-LOXO-RAS-20001
IRB No.: 12289
Title: A Phase 1a/1b Study of LY3537982 in Patients with KRAS G12C-Mutant Advanced Solid Tumors Protocol Type: Treatment
PI: Durm, Greg
Protocol Status: CLOSED TO ACCRUAL
Initiator: Cancer Center
Reason: Slow accrual
NCT ID: NCT04956640
Investigator Initiated Protocol?: N
Scope:
Exclude Protocol On Web: No

7/15/24 - SUSPENDED
Sent from OnCore on behalf of Morsal Rasouli
 
OnCore Protocol No.: CTO-LOXO-RAS-20001
IRB No.: 12289
Title: A Phase 1a/1b Study of LY3537982 in Patients with KRAS G12C-Mutant Advanced Solid Tumors Protocol Type: Treatment
PI: Durm, Greg
Protocol Status: SUSPENDED
Initiator: Cancer Center
Reason: Slow accrual
NCT ID: NCT04956640
Investigator Initiated Protocol?: N
Scope:
Exclude Protocol On Web: No

Updated on 13 Dec 2024. Study ID: CTO-LOXO-RAS-20001, 12289

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the Study Team