Metastatic Cancer Clinical Trial
Official title:
A Phase 1/2 Trial of Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Verified date | June 2024 |
Source | Mirati Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety, MTD and/or RP2D, PK, and clinical activity of the combination of adagrasib with nab-sirolimus in patients with advanced solid tumors/NSCLC with a KRAS G12C mutation.
Status | Active, not recruiting |
Enrollment | 79 |
Est. completion date | June 30, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed diagnosis of solid tumor malignancy (Phase 1) or NSCLC (Phase 2) with KRAS G12C mutation - Unresectable or metastatic disease - No available treatment with curative intent - Adequate organ function - Measurable disease per RECIST 1.1. Exclusion Criteria: - History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow - History of interstitial lung disease or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease or pneumonitis - Cardiac abnormalities |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | SCRI Oncology Partners | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Mirati Therapeutics Inc. | Aadi Bioscience, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1: Safety and tolerability in the study population. | Safety characterized by the following, as noted from first dose of study treatment to 28 days after last dose of study treatment:
Type, incidence, severity, timing, seriousness and relationship to study treatment of Adverse Events Laboratory abnormalities, as measured by changes in lab results such as hematologic or chemistry parameters while on study treatment Number of patients modifying or discontinuing study treatment due to an AE |
30 months | |
Primary | Phase 1: Maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) | Evaluate safety and assess number of patients with dose-limiting toxicity to determine the MTD/RP2D. | 30 months | |
Primary | Phase 2: Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) (Phase 2) | ORR evaluation of subjects treated with adagrasib in combination with nab-sirolimus in patients with NSCLC with KRAS G12C mutation (Study Population) will be completed. Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from first dose of study treatment until last dose of study treatment. | 30 months | |
Secondary | Area under the plasma concentration versus time curve (AUC) | AUC - nab-sirolimus and adagrasib | Up to 7 days | |
Secondary | Time to achieve maximal plasma concentration | Tmax - nab-sirolimus and adagrasib | Up to 1 days | |
Secondary | Maximum observed plasma concentration | Cmax - nab-sirolimus and adagrasib | Up to 1 days | |
Secondary | Terminal elimination half-life | t1/2 - nab-sirolimus | Up to 7 days | |
Secondary | Phase 1 and 2: Evaluate efficacy endpoints characterized by overall survival, progression-free survival, and duration of response in the study population. | Overall survival is defined as time from date of randomization to date of death due to any cause.
Progression-free survival is defined as the time from randomization to the date of Progressive Disease (PD) or death due to any cause,whichever occurs first. Duration of response defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either PD or death due to any cause, whichever occurs first. |
30 months | |
Secondary | Phase 1: Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) | ORR evaluation of subjects treated with adagrasib in combination with nab-sirolimus in patients with advanced solid tumors and NSCLC with KRAS G12C mutation (Study Population) will be completed. Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from first dose of study treatment until last dose of study treatment. | 30 months | |
Secondary | Phase 2: Safety and tolerability in the study population. | Safety characterized by the following, as noted from first dose of study treatment to 28 days after last dose of study treatment:
Type, incidence, severity, timing, seriousness and relationship to study treatment of Adverse Events Laboratory abnormalities, as measured by changes in lab results such as hematologic or chemistry parameters while on study treatment Number of patients modifying or discontinuing study treatment due to an AE, |
30 months |
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