The main objective for part 1a of the study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) and to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of oral TACH101 in participants with advanced and metastatic solid tumors. For part 1b, the main objective is the objective response rate (ORR) as assessed by radiographic progression measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Orally via capsules
UCI Health
Orange, California, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
Sarah Cannon Research Institute
Orlando, Florida, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
NEXT Oncology
Austin, Texas, United States
MD Anderson
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Phase 1a Dose Escalation: MTD of TACH101
Time frame: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1a Dose Escalation: RP2D of TACH101
Time frame: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1b Dose Expansion: ORR
Time frame: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1a Dose Escalation: Number of Participants Who Experience Dose-limiting Toxicities (DLTs)
Time frame: Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length = 28 days)
Phase 1a Dose Escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as any untoward medical occurrence in participants that happened after study drug administration. Any clinically significant abnormalities in vital signs, clinical laboratory tests, or electrocardiograms (ECGs) will be recorded as adverse events (AEs).
Time frame: Lead-in Day 1 to End of Treatment (up to approximately 204 days)
Phase 1a Dose Escalation: Area Under the Plasma Concentration-Time Curve (AUC) for TACH101
Time frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: Maximum Concentration (Cmax) of TACH101
Time frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: Observed Predose Plasma Concentration During Multiple Dosing (Ctrough) of TACH101
Time frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: Time to Reach Maximum Concentration (tmax) for TACH101
Time frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: Apparent Terminal Elimination Half-life (t1/2) of TACH101
Time frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of TACH101
Time frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: Apparent Clearance After Extravascular Administration (CL/F) of TACH101
Time frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: ORR
Time frame: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1a Dose Escalation: Duration of Response (DOR)
Time frame: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1a Dose Escalation: Clinical Benefit Rate (CBR)
Time frame: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1b Dose Expansion: Number of Participants With TEAEs
A TEAE is defined as any untoward medical occurrence in participants that happened after study drug administration. Any clinically significant abnormalities in vital signs, clinical laboratory tests, or ECGs will be recorded as AEs.
Time frame: Lead-in Day 1 to End of Treatment (up to approximately 203 days)
Phase 1b Dose Expansion: Concentration at 2 Hours Postdose (C2h) of TACH101
Time frame: Cycle 1 Day 1 to Cycle 10 Day 1 (cycle = 28 days)
Phase 1b Dose Expansion: Cmax of TACH101
Time frame: Cycle 1 Day 1 to Cycle 10 Day 1 (cycle = 28 days)
Phase 1b Dose Expansion: Ctrough of TACH101
Time frame: Cycle 1 Day 1 to Cycle 10 Day 1 (cycle = 28 days)
Phase 1b Dose Expansion: DOR
Time frame: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1b Dose Expansion: CBR
Time frame: Day 1 to End of Treatment (up to approximately 201 days)
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