A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- Conditions
- Solid Tumors
- Interventions
- Drug: GEMNabPDrug: mFOLFIRINOXDrug: FOLFOXDrug: FOLFIRI
- Registration Number
- NCT06179160
- Lead Sponsor
- Incyte Corporation
- Brief Summary
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 710
- ≥18 years old.
- Locally advanced or metastatic solid tumor with KRAS G12D mutation.
- For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome.
- Cohort specific requirements aas defined in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Prior treatment with any KRAS G12D inhibitor
- Known additional invasive malignancy within 1 year of the first dose of study drug
- History of organ transplant, including allogeneic stem cell transplantation
- Significant, uncontrolled medical condition
- History or presence of an ECG abnormality
- Inadequate organ function
Other protocol-defined Inclusion/Exclusion Criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1a: Dose Escalation monotherapy INCB161734 INCB161734 at the protocol-defined dose strength based on cohort assignment. Part 1b: Dose Expansion monotherapy INCB161734 INCB161734 at the protocol-defined dose strength based on cohort assignment. Part 1c: Pharmacodynamic cohort INCB161734 INCB161734 at the protocol-defined dose strength based on cohort assignment. Part 2a: Dose Escalation combination INCB161734 INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2a: Dose Escalation combination Cetuximab INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2a: Dose Escalation combination Retifanlimab INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2a: Dose Escalation combination GEMNabP INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2a: Dose Escalation combination mFOLFIRINOX INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2a: Dose Escalation combination FOLFOX INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2a: Dose Escalation combination FOLFIRI INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2a: Dose Escalation combination INCA33890 INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2b: Dose Expansion combination INCB161734 INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2b: Dose Expansion combination Cetuximab INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2b: Dose Expansion combination Retifanlimab INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2b: Dose Expansion combination GEMNabP INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2b: Dose Expansion combination mFOLFIRINOX INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2b: Dose Expansion combination FOLFOX INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2b: Dose Expansion combination FOLFIRI INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 2b: Dose Expansion combination INCA33890 INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Part 1d: Food-Effect INCB161734 Evaluate food effect on drug exposure as defined in the protocol.
- Primary Outcome Measures
Name Time Method Number of participants with Dose Limiting Toxicities (DLTs) Up to 28 days Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Number of participants with TEAEs leading to dose modification or discontinuation Up to 2 years and 90 days Number of participants with TEAEs leading to dose modification or discontinuation.
Number of participants with Treatment-emergent Adverse Events (TEAEs) Up to 2 years and 90 days Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab.
- Secondary Outcome Measures
Name Time Method INCB161734 pharmacokinetic (PK) in Plasma Up to approximately 90 days INCB161734 concentration in plasma.
Duration of Response (DOR) Up to 2 years Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression.
Objective Response Rate (ORR) Up to 2 years Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
Disease Control Response (DCR) Up to 2 years Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
Related Research Topics
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Trial Locations
- Locations (34)
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Stanford University
🇺🇸Palo Alto, California, United States
UCLA Healthcare Hematology-Oncology
🇺🇸Santa Monica, California, United States
Sarah Cannon Research Institue At Healthone
🇺🇸Denver, Colorado, United States
Florida Cancer Specialists
🇺🇸Sarasota, Florida, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Scroll for more (24 remaining)Mayo Clinic Hospital🇺🇸Phoenix, Arizona, United States