A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- Summary
- This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
- Short title
- A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- Official title
- A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-01-01
- First posted
- 2023-12-21
- Registry last updated
- 2026-07-22
- Primary completion date
- 2027-01-01
- Start date
- 2024-01-04
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Incyte Corporation
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06179160
- ClinicalTrials.gov ID
- NCT06179160
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Number of participants with Dose Limiting Toxicities (DLTs)
Timeframe: 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 Treatment-emergent Adverse Events (TEAEs)
Timeframe: 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.
Number of participants with TEAEs leading to dose modification or discontinuation
Timeframe: Up to 2 years and 90 days
Number of participants with TEAEs leading to dose modification or discontinuation.
INCB161734 pharmacokinetic (PK) in Plasma
Timeframe: Up to approximately 90 days
INCB161734 concentration in plasma.
Objective Response Rate (ORR)
Timeframe: 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)
Timeframe: 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.
Duration of Response (DOR)
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- ≥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
- Mayo Clinic HospitalPhoenix, United StatesRecruiting
- Stanford UniversityPalo Alto, United StatesRecruiting
- UCLA Healthcare Hematology-OncologySanta Monica, United StatesRecruiting
- Sarah Cannon Research Institue At HealthoneDenver, United StatesRecruiting
- Florida Cancer SpecialistsSarasota, United StatesRecruiting
- Sidney Kimmel Comprehensive Cancer Center At Johns HopkinsBaltimore, United StatesRecruiting
- Dana Farber Cancer InstituteBoston, United StatesRecruiting
- Hackensack University Medical CenterHackensack, United StatesRecruiting
- Weill Cornell MedicineNew York, United StatesRecruiting
- Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
- Jefferson University HospitalsPhiladelphia, United StatesRecruiting
- Scri Oncology PartnersNashville, United StatesRecruiting
- Md Anderson Cancer CenterHouston, United StatesRecruiting
- Chris Obrien LifehouseCamperdown, AustraliaRecruiting
- St Vincent'S Hospital SydneyDarlinghurst, AustraliaRecruiting
- Peter Maccallum Cancer CentreMelbourne, AustraliaRecruiting
- The Alfred HospitalMelbourne, AustraliaRecruiting
- Linear Clinical ResearchNedlands, AustraliaRecruiting
- Cliniques Universitaires Ucl Saint-LucBrussels, BelgiumRecruiting
- Universitair Ziekenhuis Antwerpen (Uza)Edegem, BelgiumRecruiting
- Universitair Ziekenhuis (Uz) LeuvenLeuven, BelgiumRecruiting
- The Ottawa Hospital Cancer CenterOttawa, CanadaRecruiting
- Princess Margaret Cancer CenterToronto, CanadaRecruiting
- Centre Leon BerardLyon, FranceRecruiting
- Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-OncopoleToulouse, FranceRecruiting
And 9 more, listed on the interactive page.
- Related resource (incyteclinicaltrials.com)
- 2023
- 2023-507091-47-00