A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
Summary
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
Arms & interventions
- DrugINCA036873
Intravenously (IV)
Outcome measures
Primary
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
Secondary
Pharmacokinetics Parameter: Cmax of INCA036873
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Tmax of INCA036873
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Cmin of INCA036873
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: AUC(0-t) of INCA036873
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: AUC 0-∞ of INCA036873
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: CL of INCA036873
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Vz of INCA036873
Time frame: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: t1/2 of INCA036873
Time frame: Up to approximately 2 years and 90 days
Objective response
Time frame: Up to approximately 2 years
Disease control
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Eligibility criteria
Study locations (8)
City of Hope Medical Center
Duarte, California, 91010
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, 92037
University of Michigan
Ann Arbor, Michigan, 48109
The University of Nebraska Medical Center
Omaha, Nebraska, 68198
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Scri Oncology Partners
Nashville, Tennessee, 37203
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Md Anderson Cancer Center
Houston, Texas, 77030