Ovarian Cancer Clinical Trial

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 projected duration of the trial through 180 days after the last dose of study medication.
Known allergic reaction against any of the components of the study treatments.

The following patients will be excluded from Cohorts B7 & C3:

Clinically significant cardiac disease or risk factors at screening.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

360

Study ID:

NCT04956640

Recruitment Status:

Recruiting

Sponsor:

Eli Lilly and Company

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There are 31 Locations for this study

See Locations Near You

USC Norris Cancer Hospital
Los Angeles California, 90033, United States More Info
Contact
855-569-6305
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States More Info
Contact
855-569-6305
Chao Family Comprehensive Cancer Ctr.
Orange California, 92868, United States More Info
Contact
855-569-6305
Yale University School of Medicine
New Haven Connecticut, 06510, United States More Info
Contact
855-569-6305
Indiana Univ Melvin & Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States More Info
Contact
855-569-6305
Community Health Network
Indianapolis Indiana, 46250, United States More Info
Contact
855-569-6305
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Contact
855-569-6305
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States More Info
Contact
855-569-6305
NYU Langone Health- Long Island
Mineola New York, 11501, United States More Info
Contact
855-569-6305
NYU Langone
New York New York, 10016, United States More Info
Contact
855-569-6305
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Contact
855-569-6305
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Contact
855-569-6305
Vanderbilt Univeristy School of Medicine
Nashville Tennessee, 37212, United States More Info
Contact
855-569-6305
South Texas Accelerated Research Therapeutics (START)
San Antonio Texas, 78229, United States More Info
Contact
855-569-6305
START Mountain Region
West Valley City Utah, 84119, United States More Info
Contact
855-569-6305
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States More Info
Contact
855-569-6305
University of Wisconsin-Madison Hospital and Health Clinic
Madison Wisconsin, 53792, United States More Info
Contact
855-569-6305
St Vincent's Hospital Sydney
Sydney New South Wales, 2010, Australia More Info
Contact
855-569-6305
Peninsula and Southeast Oncology
Frankston Victoria, 3199, Australia More Info
Contact
855-569-6305
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada More Info
Contact
855-569-6305
Centre Leon Berard
Lyon Rhône-Alpes, 69008, France More Info
Contact
855-569-6305
Gustave Roussy
Villejuif Cedex , 94805, France More Info
Contact
855-569-6305
Aichi Cancer Center Hospital
Nagoya Aichi, 464-8, Japan More Info
Contact
855-569-6305
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan More Info
Contact
855-569-6305
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan More Info
Contact
855-569-6305
Wakayama Medical University Hospital
Wakayama , 641-8, Japan More Info
Contact
855-569-6305
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of More Info
Contact
855-569-6305
The Catholic University of Korea, St. Vincent's Hospital
Suwon-si Gyeonggi-do, 16247, Korea, Republic of More Info
Contact
855-569-6305
Chonnam National University Hwasun Hospital
Hwasun Jeonranamdo, 58128, Korea, Republic of More Info
Contact
855-569-6305
Seoul National University Hospital
Seoul Korea, 03080, Korea, Republic of More Info
Contact
855-569-6305
Asan Medical Center
Seoul Korea, 05505, Korea, Republic of More Info
Contact
855-569-6305

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

360

Study ID:

NCT04956640

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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