This is a Phase 1, open-label, first-in-human study of CTX-10726 monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 Cohorts: Cohort 1 Dose Escalation and Cohort 2 Dose Expansion.
This Phase 1, open-label, first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetics profile of CTX-10726 monotherapy. Preliminary anti-tumor activity of CTX-10726 will also be assessed. The study will be conducted in 2 cohorts: Dose escalation and Dose expansion. The Dose Escalation Cohort will utilize a 3+3 design to evaluate four dose levels (0.3-10.0mg/kg) of CTX-10726 given as an IV infusion once every 2 weeks. Patients in the Dose Expansion Cohort will receive CTX-10726 as an IV infusion at dose(s) based on data from the Dose Escalation Cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Intravenous (IV) infusion (0.3-10.0mg/kg) every two weeks.
Nebraska Cancer Specialists
Omaha, Nebraska, United States
RECRUITINGSTART New York
Lake Success, New York, United States
RECRUITINGUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Cohort 1: Evaluate the safety and tolerability of CTX-10726 by incidence of treatment-emergent adverse events (TEAEs) in escalating doses
Incidence of dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-10726, average of 6 months)
Cohort 1: Determine the dose(s) of CTX-10726 to be further examined in Cohort 2 and Phase 2 studies
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks ) until 30 days after the last dose of CTX-10726 (average of 6 months)
Cohort 2: Evaluate the safety and tolerability of CTX-10726 by incidence of treatment-emergent adverse events (TEAEs) at dose(s) selected from Cohort 1
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-10726 (up to 2 years)
Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Baseline until confirmed disease progression (up to 2 years)
Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: From the date of first confirmed complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease (up to 2 years)
Disease Control Rate (DCR) percentage of patients with best overall response of CR, PR, or SD as per RECIST version 1.1
Time frame: From first dose of CTX-10726(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occur first (up to 2 years)
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Prisma Health Cancer Institute
Greenville, South Carolina, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGClinical Benefit Rate (CBR) percentage of patients with best overall response of CR, PR, or SD for ≥ 6 months as per RECIST version 1.1
Time frame: From first dose of CTX-10726(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occur first (up to 2 years)
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: From first dose of CTX-10726(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occur first (up to 2 years)
Overall Survival (OS)
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1,Cycle = 2 weeks) until death (up to 2 years)
Maximum serum concentration (Cmax) of CTX-10726
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1 = 2 weeks) until treatment discontinuation
Time of maximum serum concentration (Tmax) of CTX-10726
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Trough concentration (Ctrough) of CTX-10726
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Area under the curve (AUC) of CTX-10726
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation
Clearance (CL) of serum concentrations of CTX-10726
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Volume of distribution (Vd) of serum concentrations of CTX-10726
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Terminal elimination half-life (t1/2) of serum concentrations of CTX-10726
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Dose response for CTX-10726
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Assess the immunogenicity of CTX-10726 screen for the presence and development of antibodies against CTX-10726
Time frame: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until end of treatment visit