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Protocol No. UW17053
Principal Investigator Uboha, Nataliya
Age Group Adult
Sponsor Type Industry
Title A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors
Objective The purpose of the research study is being done to learn more about a new experimental drug called TSR-022 and its effect on cancer when used either alone or with another experimental drug called TSR-042. This study is divided into 2 parts; Part 2 of this study will enroll patients with advanced melanoma, advanced colorectal cancer (CRC) and advanced non-small cell lung cancer (NSCLC).
The main purposes of Part 2 are to:
Look at the ability of TSR-022 when taken alone or in combination with TSR-042 to make the cancer smaller
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken by itself
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken with TSR-042 as Combination Therapy.
The main purposes of Part 2 are to:
Treatment TSR-002 alone or in combination with TSR-042
Description Phase I dose escalation and dose expansion using TSR-022 and TSR-042
Must have advanced or metastatic solid tumors that have progressed after treatment with available therapies that are known to confer clinical benefit or patients who are intolerant to standard treatment and meet the following criteria:
Histologically proven advanced (unresectable) or metastatic solid tumor that meets 1 of the following disease types:
Melanoma advanced or metastatic melanoma who have progressed following treatment with an anti-PD-1 or anti-PD-L1 antibody
Advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed following treatment with an anti-PD-1 or anti-PD-L1 antibody
Patients with a known epidermal growth factor receptor (EGFR) mutation must have received an EGFR tyrosine kinase inhibitor (TKI) (eg, erlotinib, gefitinib, afatinib, osimertinib, or experimental)
Patients with a known anaplastic lymphoma kinase (ALK) translocation must have received an ALK inhibitor (eg, crizotinib, ceritinib, alectinib, or experimental) Patients with a known ROS1 mutation must have received a ROS1 inhibitor (eg, crizotinib)
Patients with advanced/metastatic colorectal cancer who have progressed following standard treatment which must include fluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated.
Patients with melanoma and or colorectal cancer must have lesions amenable for biopsy and agree to undergo biopsies prior to treatment, approximately 4 to 6 weeks after treatment and, if possible, at the time of disease progression
Patients with non-small cell lung cancer must have archival tumor tissue available and if tissue is not available must be willing to have a tumor tissue biopsy performed
In addition, tumor biopsies are mandatory for accessible lesions prior to treatment, approximately 4 to 6 weeks after treatment, and, if possible, at the time of disease progression
Female patients must have a negative serum or urine pregnancy test if of childbearing potential or be of nonchildbearing potential.
Female patients of childbearing potential must agree to use 2 adequate methods of contraception with their partner
ECOG performance status of ≤ 1
Adequate hematologic and organ function
Prior treatment with anti-PD-1, antiPD-L1, or anti-PD-L2 agent that resulted in permanent discontinuation due to an adverse event
Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis.
Applicable Disease Sites Colon and Rectum; Lung; Melanoma/Skin cancer
Participating Institutions UW Hospital and Clinics