The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
195
Dana-Farber/Massachusetts General Hospital, Inc
Boston, Massachusetts, United States
NOT_YET_RECRUITINGNew Experimental Therapeutics of San Antonio LLC
San Antonio, Texas, United States
RECRUITINGSTART - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Number of Participants with Dose-limiting Toxicities (DLT)
Time frame: Cycle 1 (Cycle length=21 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 24 months
Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent Discontinuations
Time frame: Up to 24 months
Cmax/C0: Maximum Blood Concentration (Cmax) and/or Concentration at Time 0 (C0) of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Tmax: Time to Reach Cmax of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-t: Area Under the Curve From time 0 to the time of the Last Quantifiable Concentration of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
t1/2: Terminal Elimination Half-life of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-∞: Area Under the Curve From Time 0 Extrapolated to Infinity of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
CL: Clearance of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
START Mountain Region
West Valley City, Utah, United States
NOT_YET_RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGVd: Volume of Distribution of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Overall Response Rate (ORR)
ORR will be determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: Up to 12 months
Duration of Response (DOR)
DOR will be determined by radiographic disease assessments per RECIST 1.1.
Time frame: Up to 12 months
Number of Participants with Antitumor Activity Markers in Peripheral Blood of PT0511
Time frame: Cycle 1 Day 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Overall Survival (OS)
OS is defined as the time from enrollment up to death due to any cause.
Time frame: At 1 year
Progression-free Survival (PFS)
PFS will be determined by radiographic disease assessments per RECIST 1.1.
Time frame: At 1 year