The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of REC-7735 in participants with unresectable, locally advanced, or metastatic PIK3CA-H1047R mutated solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Oral
START Midwest
Grand Rapids, Michigan, United States
RECRUITINGNEXT Oncology - Dallas
Irving, Texas, United States
NOT_YET_RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
NOT_YET_RECRUITINGPhase 1A: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2 years
Phase 1B: Objective Response Rate (ORR) According to Standard Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to 2 years
Maximum (Peak) Drug Concentration (Cmax) of REC-7735
Time frame: Up to 2 years
Time to Reach Cmax following drug administration (Tmax) of REC-7735
Time frame: Up to 2 years
Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of REC-7735
Time frame: Up to 2 years
Phase 1A: ORR According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Clinical Benefit Rate (CBR) According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Duration of Response (DOR) According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Duration of Stable Disease (SD) According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Time to Response (TTR) According to Standard RECIST 1.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 2 years
Phase 1B: Progression-free Survival (PFS) According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Overall Survival
Time frame: Up to 2 years