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Small Molecule Inhibitor
LY3537982 for Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA)
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Must not have
Have a serious cardiac condition
Disease suitable for local therapy administered with curative intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called LY3537982 in cancer patients with the KRAS G12C mutation. It targets this mutation to stop cancer cells from growing. The study includes patients who haven't responded to other treatments or cannot tolerate them. LY3537982 is a new drug targeting the KRAS G12C mutation, similar to previously approved drugs like sotorasib and adagrasib.
Who is the study for?
This trial is for cancer patients with a KRAS G12C mutation who've tried or can't tolerate standard treatments. It's open to those with certain cancers, like pancreatic and lung, if they have measurable disease, good organ function, an ECOG status of 0 or 1, and agree to use contraception. Some untreated NSCLC patients may join under specific conditions.
What is being tested?
The study tests LY3537982's safety and effectiveness in treating various cancers with the KRAS G12C mutation. Patients will also receive other drugs like Pemetrexed and Pembrolizumab depending on their condition. The trial aims to include participants for up to four years.
What are the potential side effects?
Potential side effects could include reactions related to the immune system due to Pembrolizumab, issues from chemotherapy agents like Pemetrexed (nausea, fatigue), as well as risks associated with new drug LY3537982 which are being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a KRAS G12C mutation.
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I am fully active or can carry out light work.
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I have had treatment with oxaliplatin or irinotecan for advanced colorectal cancer.
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My cancer is advanced, cannot be surgically removed, and/or has spread.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious heart condition.
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My condition can be treated with the goal of curing it.
Select...
I currently have an infection that is not being treated.
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I have not been diagnosed or treated for another cancer within the last 3 years.
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I had severe side effects from previous immunotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ estimated up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy
Phase 1b: To assess the safety and tolerability of LY3537982 when administered alone or in combination with other investigational agents
Phase 1b: To determine the optimal dose of LY3537982 to be administered to treatment-naïve participants with advanced NSCLC in combination with pembrolizumab
Secondary study objectives
To assess preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Objective response rate (ORR)
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Best Overall Response (BOR)
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Disease control rate (DCR)
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: LY3537982 (Dose Optimization)Experimental Treatment3 Interventions
LY3537982 administered orally either alone or with another investigational agent
Group II: LY3537982 (Dose Expansion)Experimental Treatment6 Interventions
LY3537982 administered orally either alone or with another investigational agent.
Group III: LY3537982 (Dose Escalation)Experimental Treatment1 Intervention
LY3537982 administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3537982
2023
Completed Phase 1
~130
Pembrolizumab
2017
Completed Phase 3
~3130
Cetuximab
2011
Completed Phase 3
~2480
Pemetrexed
2014
Completed Phase 3
~5550
Cisplatin
2013
Completed Phase 3
~3120
Carboplatin
2014
Completed Phase 3
~6120
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy drugs like fluorouracil and oxaliplatin work by interfering with DNA replication, leading to cancer cell death.
Targeted therapies, such as cetuximab and bevacizumab, inhibit specific molecules involved in cancer growth and spread; cetuximab targets the epidermal growth factor receptor (EGFR), while bevacizumab inhibits vascular endothelial growth factor (VEGF). KRAS G12C inhibitors, like LY3537982, specifically target the KRAS G12C mutation, blocking the abnormal signaling pathways that drive cancer cell proliferation.
These treatments are crucial as they offer more personalized and effective options, potentially leading to better outcomes and fewer side effects for colorectal cancer patients.
Targeted therapies for gallbladder cancer: an overview of agents in preclinical and clinical development.Sensitivity of KRAS-Mutant Colorectal Cancers to Combination Therapy That Cotargets MEK and CDK4/6.
Targeted therapies for gallbladder cancer: an overview of agents in preclinical and clinical development.Sensitivity of KRAS-Mutant Colorectal Cancers to Combination Therapy That Cotargets MEK and CDK4/6.
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,465,193 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
10,510 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,028 Previous Clinical Trials
5,188,985 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I have an autoimmune disease treated with medication in the last 2 years.I have advanced NSCLC, haven't had treatment for it, and may start some treatments soon.My cancer has a KRAS G12C mutation.My organs are functioning well.I have stopped all cancer treatments and don't have major ongoing side effects.I have a serious heart condition.I am fully active or can carry out light work.My condition can be treated with the goal of curing it.I currently have an infection that is not being treated.I have not been diagnosed or treated for another cancer within the last 3 years.I can swallow pills.I have had treatment with oxaliplatin or irinotecan for advanced colorectal cancer.I had severe side effects from previous immunotherapy.My cancer is advanced, cannot be surgically removed, and/or has spread.I have brain metastases but am stable and haven't needed steroids in the last 2 weeks.I have previously been treated with a KRAS G12C inhibitor, except in specific allowed cases.
Research Study Groups:
This trial has the following groups:- Group 1: LY3537982 (Dose Optimization)
- Group 2: LY3537982 (Dose Escalation)
- Group 3: LY3537982 (Dose Expansion)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.