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.
Age 18 years or older.
Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to cure by surgery or other means.
Patients who have progressed after a minimum of 2 doses of a programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PDL1) treatment.
Patients must have received at least one regimen including a tyrosine kinase inhibitor (TKI).
Developed clinically significant adverse reaction to prior PD-1 or PD-L1 therapy, including immune related adverse reactions (irAE), that led to discontinuation of treatment. A prior irAE may be considered not exclusionary only after consultation with the Medical Monitor if it resolved or stabilized to Grade 1 or baseline before informed consent, has been clinically stable for at least 3 months, and does not require ongoing systemic corticosteroids or other systemic immunosuppressive therapy other than protocol-permitted physiologic replacement. Participants are not eligible if the prior irAE was severe or life-threatening, involved a high-risk organ system with potentially dangerous recurrence, was recurrent or occurred after rechallenge, required second-line immunosuppressive therapy beyond corticosteroids, suggested broad immune susceptibility, or could confound safety evaluation in this first-in-human study.
Prior organ transplantation.
History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.
History of other neoplasms within 3 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has undergone successful surgery.
Single group
CTX-10726
DrugIntravenous (IV) infusion (0.3-10.0mg/kg) every two weeks.
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.
Cohort 1: Determine the dose(s) of CTX-10726 to be further examined in Cohort 2 and Phase 2 studies
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)
Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Disease Control Rate (DCR) percentage of patients with best overall response of CR, PR, or SD as per RECIST version 1.1
Clinical Benefit Rate (CBR) percentage of patients with best overall response of CR, PR, or SD for ≥ 6 months as per RECIST version 1.1
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