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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, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.
Study details:
This is an open-label, multicenter Phase 1/2 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 4 parts: Phase 1a dose escalation, Phase 1b dose expansion, Phase 1b dose optimization, and Phase 2. KRAS G12C mutations will be identified through standard of care testing.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-07-19
Primary completion: 2026-06-01
Study completion finish: 2026-06-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT04956640
Intervention or treatment
DRUG: LY3537982
DRUG: Pembrolizumab
DRUG: Cetuximab
DRUG: Pemetrexed
DRUG: Cisplatin
DRUG: Carboplatin
Conditions
- • Carcinoma, Non-Small-Cell Lung
- • Colorectal Neoplasms
- • Endometrial Neoplasms
- • Ovarian Neoplasms
- • Pancreatic Neoplasms
- • Biliary Tract Neoplasms
Find a site
Closest Location:
Royal North Shore Hospital
Research sites nearby
Select from list below to view details:
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
St Vincent's Hospital Sydney
Sydney, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: LY3537982 (Dose Escalation)
| DRUG: LY3537982
|
EXPERIMENTAL: LY3537982 (Dose Expansion)
| DRUG: LY3537982
|
EXPERIMENTAL: LY3537982 (Dose Optimization)
| DRUG: LY3537982
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy | Measured by the number of patients with dose-limiting toxicities (DLTs) | Cycle 1 (21 Days) |
Phase 1b: To assess the safety and tolerability of LY3537982 when administered alone or in combination with other investigational agents | Measured by the number of patients with dose-limiting toxicities (DLTs) | Cycle 1 (21 Days) |
Phase 1b: To determine the optimal dose of LY3537982 to be administered to treatment-naïve participants with advanced NSCLC in combination with pembrolizumab | Measured by TEAEs | Estimated up to 2 years |
To determine the optimal dose of LY3537982 to be administered to participants who have received at least one prior oxaliplatin- or irinotecan-containing regimen for advanced or metastatic CRC in combination with cetuximab | Not Specified | Estimated up to 2 years |
To assess the antitumor activity of LY3537982 monotherapy in participants with advanced pancreatic cancer with KRAS G12C mutation | Not Specified | Estimated up to 2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
To assess preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Objective response rate (ORR) | ORR | Estimated up to 2 years |
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Duration of Response (DOR) | DOR | Estimated up to 2 years |
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Best Overall Response (BOR) | BOR | Estimated up to 2 years |
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Time to response (TTR) | TTR | Estimated up to 2 years |
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Disease control rate (DCR) | DCR | Estimated up to 2 years |
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Progression-free survival (PFS) | PFS | Estimated up to 2 years |
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Overall survival (OS) | OS | Estimated up to 2 years |
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Intracranial DOR based on modified RECIST v1.1 (Certain arms of the study only) | Intracranial DOR | Estimated up to 2 years |
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Whole-body ORR based on RECIST v1.1 and modified RECIST v1.1 (Certain arms of the study only) | Whole-body ORR | Estimated up to 2 years |
To characterize the pharmacokinetics (PK) properties of LY3537982: Area under the plasma concentration versus time curve (AUC) | PK: AUC of LY3537982 | Predose estimated up to 2 years |
To characterize the PK properties of LY3537982: Maximum drug concentration (Cmax) | PK: Cmax of LY3537982 | Predose estimated up to 2 years |
Frequently Asked Questions
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