The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including triple negative breast cancer (TNBC), and to determine a recommended Phase 2 dose level for future studies in TNBC.
This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PQ203 in patients with selected advanced solid tumors. PQ203 will be administered as a once-weekly intravenous infusion. The study consists of two parts: Phase 1A (dose escalation/expansion) and Phase 1B (dose optimization). * Phase 1A will employ a dose-escalation design in patients with advanced solid tumors to assess the safety and tolerability of PQ203 as monotherapy and to establish a provisional Recommended Phase 2 Dose (RP2D). A dose-expansion component will further evaluate the provisional RP2D in one or more selected tumor types. * Phase 1B will assess the provisional RP2D and further characterize safety, pharmacokinetics, and preliminary efficacy. Endpoints: * Primary Endpoints: Incidence of treatment-emergent adverse events (TEAEs) and determination of the RP2D. * Secondary Endpoints: Pharmacokinetic profile of PQ203 and its payload (MMAE), and preliminary evidence of antitumor activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
PQ203 is a peptide drug-conjugate given once weekly by intravenous infusion intended for the treatment of advanced solid tumor cancers including triple negative breast cancer.
MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGIncidence of treatment-emergent Adverse Events
The incidence and severity of Adverse Events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) to assess safety and tolerability.
Time frame: From the time of informed consent until ~28 days after the last dose of PQ203
Objective Response Rate (ORR)
Tumor growth will be assessed using standard imaging techniques and scored by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). An Objective response rate (ORR), defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) will be calculated to assess preliminary signals of anti-tumor activity.
Time frame: From informed consent until ~28 days after the last dose of PQ203
Progression free survival
Progression free survival (PFS; time from first dose to date of documentation of disease progression) in months will be determined.
Time frame: From informed consent to ~28 days after the last dose of PQ203
Pharmacokinetics: Determine the Cmax of PQ203
Plasma concentration-time profiles will be used to identify the maximum drug concentration in plasma (ng PQ203/mL)
Time frame: From first day of dosing to ~28 days after the last day of dosing
Pharmacokinetics: half-life of PQ203 in plasma
Plasma concentration-time profiles will be used to determine the half life (in hours) of PQ203 in plasma
Time frame: From first day of dosing until ~28 days after the last dose
Pharmacokinetics: PQ203 exposure
Plasma concentration-time profiles will be used to determine the area under the curve (AUC) in ng/mL x hours
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Time frame: from first dose through ~28 days after the last dose
Duration of Objective Response
Duration of objective response (complete or partial response) by RECIST 1.1 in months
Time frame: From Informed consent to ~28 days after the final dose