Ovarian Cancer Clinical Trial
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
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.
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.
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.
For some parts of the study, histologically or cytologically confirmed Stage IIIB-IIIC or Stage IV NSCLC that is previously untreated in the advanced/metastatic setting and not suitable for curative intent radical surgery or radiation therapy.
For some parts of the study, patients must be PD-L1 positive, (TPS greater than or equal to 1%)
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. This only applies to some parts of the study.
Have received prior treatment with any KRAS G12C small molecule inhibitor, except in certain scenarios where such prior therapy is allowed as per protocol.
Patients treated with drugs known to be strong inhibitors or inducers of cytochrome P450 (CYP)3A may be excluded.
The following patients will be excluded from some parts of the study:
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 40 Locations for this study
Birmingham Alabama, 35233, United States More Info
Los Angeles California, 90033, United States More Info
Newport Beach California, 92663, United States More Info
Orange California, 92868, United States More Info
New Haven Connecticut, 06510, United States More Info
Gainesville Florida, 32610, United States More Info
Indianapolis Indiana, 46202, United States More Info
Indianapolis Indiana, 46250, United States More Info
Boston Massachusetts, 02114, United States More Info
Lebanon New Hampshire, 03756, United States More Info
Mineola New York, 11501, United States More Info
New York New York, 10016, United States More Info
New York New York, 10065, United States More Info
Philadelphia Pennsylvania, 19111, United States More Info
Pittsburgh Pennsylvania, 15232, United States More Info
Nashville Tennessee, 37212, United States More Info
San Antonio Texas, 78229, United States More Info
West Valley City Utah, 84119, United States More Info
Fairfax Virginia, 22031, United States More Info
Madison Wisconsin, 53792, United States More Info
St Leonards New South Wales, 2065, Australia More Info
Sydney New South Wales, 2010, Australia More Info
Frankston Victoria, 3199, Australia More Info
Nedlands Western Australia, 6009, Australia More Info
Edmonton Alberta, T6G 1, Canada More Info
Toronto Ontario, M5G 2, Canada More Info
Lyon Rhône-Alpes, 69008, France More Info
Bordeaux , 33076, France More Info
Montpellier Cedex 5 , 34298, France More Info
Toulouse , 31059, France More Info
Villejuif Cedex , 94805, France More Info
Nagoya Aichi, 464-8, Japan More Info
Kashiwa Chiba, 277-8, Japan More Info
Chuo-ku Tokyo, 104-0, Japan More Info
Wakayama , 641-8, Japan More Info
Goyang-si Gyeonggi-do, 10408, Korea, Republic of More Info
Suwon-si Gyeonggi-do, 16247, Korea, Republic of More Info
Hwasun-gun Jeonranamdo, 58128, Korea, Republic of More Info
Seoul Korea, 03080, Korea, Republic of More Info
Seoul Korea, 05505, Korea, Republic of More Info
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.