Melanoma Clinical Trial
XTX101 Monotherapy and XTX101 and Pembrolizumab Combination Therapy in Patients With Advanced Solid Tumors
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and pembrolizumab combination therapy in patients with advanced solid tumors.
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of XTX101, a tumor-selective anti-CTLA-4 antibody, as monotherapy and XTX101 and pembrolizumab combination therapy in patients with advanced solid tumors.
Part 1A will examine XTX101 monotherapy in an accelerated and standard 3+3 dose escalation design. Based on the results of Part 1A, patients with select advanced solid tumors will be enrolled in Part 1B, which will evaluate XTX101 monotherapy in relation to specific PD biomarkers.
Part 1C will examine XTX101 in combination with pembrolizumab in a standard 3+3 dose escalation design, examining up to 2 dose levels of XTX101 in combination with the labeled dose of pembrolizumab. After completion of Part 1C, the study will initiate Part 2, examining the RP2D of XTX101 and pembrolizumab combination therapy in patients with unresectable or metastatic melanoma.
Disease Criteria - Part 1A and 1C- Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available; Part 1B - Any histologically or cytologically confirmed solid tumor malignancy for which anti-PD-1 or anti-PD-L1 treatment is approved and has progressed on or after prior anti-PD-1 or anti-PD-L1 therapy. Part 2- histologically or cytologically confirmed unresectable or metastatic melanoma that has not been treated with prior anti-PD-1 or anti-PD-L1 therapy
ECOG performance status of 0 or 1
Adequate organ function
Part 2 only: measurable disease per iRECIST
Received prior treatment with anti-CTL-4 therapy
Received prior immune-checkpoint therapy and experienced Grade 3 or greater toxicity lasting greater than 6 weeks
Received prior systemic anticancer therapy within 4 weeks prior to study treatment
Received prior radiotherapy within 2 weeks prior to study treatment
Has a diagnosis of immunodeficiency
Has known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years
Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs
Has an active infection requiring systemic therapy within 4 weeks prior to study treatment
Has a history of severe hypersensitivity reaction (≥ Grade 3) to any study intervention and/or any of its excipients
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Part 2 only: has ocular melanoma
Part 2 only: has received prior anti-PD-1/L-1 therapy
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