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

  • STATUS
    Recruiting
  • End date
    Nov 25, 2023
  • participants needed
    360
  • sponsor
    Eli Lilly and Company
Updated on 25 October 2022
cancer
measurable disease
KRAS
erlotinib
pembrolizumab
cetuximab

Summary

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. The study will last up to approximately 2 years.

Description

This is an open-label, multicenter Phase 1 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 2 parts, Part 1a is a dose escalation and Part 1b is a dose expansion. Part 1a will establish a recommended Phase 2 dose. Part 1b will have multiple arms of either monotherapy or in combination with other drugs.

KRAS G12C mutations will be identified through standard of care testing.

Details
Condition Carcinoma, Non-Small-Cell Lung, Colorectal Neoplams, Endometrial Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
Treatment Cetuximab, Pembrolizumab, Erlotinib, Abemaciclib, TNO155, Sintilimab, LY3537982, Temuterkib, LY3295668
Clinical Study IdentifierNCT04956640
SponsorEli Lilly and Company
Last Modified on25 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA)
Participants must have a histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Have adequate organ function
Have discontinued all previous treatments for cancer with resolution of any significant ongoing adverse events (AEs)
Must be able to swallow capsule/tablet
Agree and adhere to contraceptive use, if applicable

Exclusion Criteria

Disease suitable for local therapy administered with curative intent
Have an active, ongoing, or untreated infection
Have a serious pre-existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
Have a serious cardiac condition
Have a second active primary malignancy or have been diagnosed and/or treated for an additional malignancy within 3 years prior to enrollment
Have symptomatic central nervous system (CNS) malignancy or metastasis and/or carcinomatous meningitis. Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids in excess of 10 milligrams (mg) per day prednisone/prednisolone (or equivalent) and their disease is asymptomatic and radiographically stable for at least 30 days
Have received prior treatment with any KRAS G12C small molecule inhibitor, except in certain scenarios where such prior therapy is allowed as per protocol
For Cohorts B2, B3, and B5/C1, patients treated with drugs known to be strong inhibitors or inducers of cytochrome P450 (CYP)3A
The following patients will be excluded from Cohort B4
Experienced certain serious side effects with prior immunotherapy
Have an active autoimmune disease that has required systemic anti-autoimmune treatment in the past 2 years
Have received a live vaccine within 30 days prior to the first dose of study drug
Pregnant, breastfeeding, or expecting to conceive or father children within the
Known allergic reaction against any of the components of the study treatments
projected duration of the trial through 180 days after the last dose of study
medication
The following patients will be excluded from Cohorts B7 & C3
Clinically significant cardiac disease or risk factors at screening
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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