Solid Tumors
Conditions
Keywords
INCB161734, KRASG12D Mutation, pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC)
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.
Interventions
DRUGINCB161734
INCB161734 will be administered at protocol defined dose.
DRUGCetuximab
Cetuximab will be administered at protocol defined dose.
DRUGRetifanlimab
Retifanlimab will be administered at protocol defined dose.
DRUGGEMNabP
GEMNabP will be administered at protocol defined dose.
DRUGmFOLFIRINOX
mFOLFIRINOX will be administered at protocol defined dose.
DRUGFOLFOX
FOLFOX will be administered at protocol defined dose.
DRUGFOLFIRI
FOLFIRI will be administered at protocol defined dose.
DRUGINCA33890
INCA33890 will be administered at protocol defined dose.
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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.
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| INCB161734 pharmacokinetic (PK) in Plasma | Up to approximately 90 days | INCB161734 concentration in plasma. |
| 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. |
| 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. |
Countries
Australia, Belgium, Canada, France, Italy, Japan, Spain, United States
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed