Study of LY3537982 for Patients with Advanced Solid Tumors with KRAS G12C Mutation

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What is this study about?

This clinical trial is focused on studying a type of cancer known as KRAS G12C-mutant advanced solid tumors. These are cancers that have a specific genetic change called the KRAS G12C mutation. The trial is testing a new treatment called LY3537982, which is a small molecule inhibitor designed to target this mutation. The treatment is taken orally in the form of a capsule.

The purpose of the study is to find the best dose of LY3537982 and to understand its safety and effectiveness in treating these cancers. The study will also explore how well the treatment works when used alone and in combination with other cancer therapies. Participants will receive the treatment and be monitored for any side effects and how their cancer responds to the medication.

Throughout the study, researchers will collect information on the treatment’s impact on the cancer, including any changes in tumor size and overall health. The study aims to provide valuable insights into the potential benefits of LY3537982 for patients with KRAS G12C-mutant advanced solid tumors.

1 joining the study

Upon joining the study, the patient must provide consent and meet specific criteria, such as being 18 years or older and having a measurable disease with a KRAS G12C mutation.

The patient must have stopped all previous cancer treatments and recovered from major side effects.

2 initial assessment

The patient undergoes an initial assessment to confirm eligibility, including tests to ensure adequate organ function and an ECOG performance status of 0 or 1.

3 phase 1a: dose escalation

The patient receives the medication LY3537982 in capsule form, taken orally.

The purpose is to identify the optimal dose and assess safety and tolerability.

4 phase 1b: dose expansion

The patient may be part of different cohorts based on their specific condition, such as untreated advanced/metastatic NSCLC or having brain metastasis.

The medication continues to be administered to evaluate its antitumor activity.

5 phase 2: further evaluation

The patient continues to receive LY3537982 to further assess its effectiveness and safety over a longer period.

The study aims to gather more data on the medication’s impact on the tumor.

6 monitoring and follow-up

Throughout the trial, the patient is regularly monitored for any side effects or changes in their condition.

Regular follow-up appointments are scheduled to track progress and adjust treatment as necessary.

Who Can Join the Study?

Individuals must be able to provide consent and be at least 18 years old.
Individuals must have a disease that can be measured using specific medical guidelines called RECIST v1.1.
Individuals must have a solid tumor with a specific genetic change called a KRAS G12C mutation. If they have a type of lung cancer called NSCLC and have tried a treatment for this mutation before, they can still join if the mutation is confirmed within 3 months of stopping the previous treatment.
For Phase 1a Dose escalation, individuals must have an advanced solid tumor and not be candidates for approved treatments.
For Phase 1b Dose expansion Part B, individuals must have advanced or metastatic NSCLC that has not been treated before. They can have had one prior 21-day cycle of a treatment called the KEYNOTE-189 regimen.
For Phase 1b Dose expansion Part B, individuals must have at least one untreated, active brain metastasis.
For Phase 1b Dose expansion Part C and Dose Optimization Part H, individuals must have received at least one prior treatment containing oxaliplatin or irinotecan for advanced or metastatic colorectal cancer (CRC).
For Phase 1b Dose expansion Part D, individuals must have an unremovable solid tumor with a KRAS G12C mutation that is not NSCLC, CRC, or pancreatic cancer.
For Phase 1b Dose expansion Part E, individuals must have progressed on a KRAS G12C inhibitor.
For Phase 2 Part F, individuals must have unresectable pancreatic cancer with a KRAS G12C mutation.
For Phase 1b Dose Optimization Part G, individuals must have previously untreated advanced or metastatic NSCLC. They can have had one prior 21-day cycle of a treatment called pembrolizumab.
Individuals must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Individuals must have adequate organ function, which will be checked through blood tests.
Individuals must have stopped all previous cancer treatments and recovered from the major side effects.

Who Cannot Join the Study?

Patients who do not have KRAS G12C-mutant advanced solid tumors cannot participate. This means the specific type of cancer mutation must be present.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those who might not be able to give informed consent, cannot participate.
Patients who are not able to safely receive the study treatment due to other health conditions or medications they are taking cannot participate.
Patients who have previously received certain treatments that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study may pose risks to the baby.
Patients who have a history of certain medical conditions that could affect the study results cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Itiscavk Rincewdj Da Cizzqs Dk Mlvzfguijjv	Montpellier	France
Cssqjk Lqwz Bhfqra	Lyon	France
Ihsysrlm Bywjpncm	Bordeaux	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	21.07.2022

Trial locations

Investigated drugs:

LY3537982 is an investigational medication being studied for its potential to treat advanced solid tumors that have a specific mutation known as KRAS G12C. This medication is being tested to determine the best dose, its safety, how well patients can tolerate it, and its effectiveness in shrinking tumors. It is being evaluated both on its own and in combination with other cancer treatments.

KRAS G12C-Mutant Advanced Solid Tumors – This condition involves a mutation in the KRAS gene, specifically at the G12C position, which leads to the development of advanced solid tumors. These tumors can occur in various organs and are characterized by uncontrolled cell growth due to the mutation. The progression of the disease is marked by the spread of cancerous cells beyond their original location, often leading to the formation of secondary tumors. The mutation affects the signaling pathways that regulate cell division and survival, contributing to tumor growth. As the disease advances, it may lead to increased tumor burden and potential complications related to the affected organs. The focus of research is on understanding the mutation’s role in tumor development and exploring targeted therapies.

Trial ID:

2022-502756-31-00

Protocol code:

LOXO-RAS-20001

NCT ID:

NCT04956640

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of LY3537982 for Patients with Advanced Solid Tumors with KRAS G12C Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?