Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors
A Phase 1, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHS-006, as Monotherapy and in Combination with Toripalimab, in Participants with Advanced Solid Tumors
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Clinical Trial Information
Trial Contact: Donaldson, Karin M; Djuro, Victor; Frankos, Marie; Caldwell, Chloe M; Simoni, Christine; Casillas, Bridey L; Rodriguez Saavedra, Carlis M; Waris, Seema
Trial Phone: 321.841.9821 ; 321.841.7477 ; 321.841.7303 ; (321)841.1107 ; 321.841.7293 ; 321.841.8284 ; 321.841.6764 ; 321.841.1907
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IRB No: 21.187.11
Protocol Abbrev: CHS-006-01
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase I
Age Group: Adult
Secondary Protocol No: TAB006-01 previously
Treatment: CHS-006-01 Toripalimab
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05757492
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Objective
This phase 1 open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CHS-006 in combination with toripalimab in 2 phases. Phase 1 (Dose Optimization phase) will explore 2 different dose combinations in participants with advanced/metastatic solid tumors (except pancreatic) and Phase 2 (Indication-specific Expansion phase) will use one selected dose in specific tumor types (non-small cell lung cancer-non squamous [NSCLC-NS] and Hepatocellular carcinoma [HCC])
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Key Eligibility
All phases: male or female ≥18 years of age, ECOG Performance Status (PS) 0-1, adequate organ function, no history of autoimmune disease, no prior exposure to drugs targeting TIGIT or its ligands. For full details see Section 4.2 and 4.3.
In the Dose Escalation (Parts A and B) and Dose Expansion Phases, patients must have disease progression on standard therapy, or be ineligible for or intolerant of available approved standard therapies known to confer clinical benefit (including immunotherapy) or for whom no effective standard therapy exists.
Indication-specific expansion phase: patients must have one of the specified advanced malignancies (up to four primary cancers) that has progressed after at least one prior line of standard therapy.
