A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Intravenously (IV)
City of Hope Medical Center
Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)
Toxicities occurring during the first study drug infusion and continues through 28 days as defined in the protocol. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.
Time frame: Up to Day 28
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Cmax of INCA036873
Defined as maximum observed plasma concentration of INCA036873.
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Tmax of INCA036873
Defined as the time to reach the maximum plasma concentration of INCA036873.
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Cmin of INCA036873
Defined as the minimum observed plasma concentration of INCA036873.
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: AUC(0-t) of INCA036873
Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036873.
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: AUC 0-∞ of INCA036873
Defined as the area under the concentration-time curve from 0 to infinity of INCA036873.
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Duarte, California, United States
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States
NOT_YET_RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGThe University of Nebraska Medical Center
Omaha, Nebraska, United States
NOT_YET_RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
NOT_YET_RECRUITINGScri Oncology Partners
Nashville, Tennessee, United States
RECRUITINGVanderbilt Medical Center
Nashville, Tennessee, United States
NOT_YET_RECRUITINGMd Anderson Cancer Center
Houston, Texas, United States
NOT_YET_RECRUITINGMacquarie University Hospital
Sydney, New South Wales, Australia
RECRUITINGPrincess Alexandra Hospital Australia
Woolloongabba, Queensland, Australia
NOT_YET_RECRUITING...and 12 more locations
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: CL of INCA036873
Defined as the apparent oral dose clearance of INCA036873.
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Vz of INCA036873
Defined as the apparent oral dose volume of distribution of INCA036873.
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: t1/2 of INCA036873
Defined as the apparent terminal phase disposition half-life of INCA036873.
Time frame: Up to approximately 2 years and 90 days
Objective response
Defined as a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator.
Time frame: Up to approximately 2 years
Disease control
Defined as a BOR of CR, PR, or Stable Disease (SD), as assessed by the investigator.
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Defined as the time from the earliest date of a documented objective response (CR or PR) to the earliest date of disease progression (per investigator assessment using the appropriate criteria) or death from any cause, whichever occurs first.
Time frame: Up to approximately 2 years