A Phase I, First-in-Human, Open-Label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Subjects With Advanced Solid Tumors

SIM0348-101

This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).

2023-04-01

2024-12-30

2025-12-30

Not yet recruiting

Early phase I

68

Inclusion Criteria: * Adults 18 years of age or older * Must have failed at least one established standard anti-cancer therapies * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy at least 12 weeks * Adequate hematologic and end organ function * Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care * Confirmed availability of representative tumor specimens * Measurable disease according to RECIST Version 1.1 Exclusion Criteria: * Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1 * Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases * History of interstitial lung disease, evidence of active pneumonitis (history of radiation pneumonitis in the radiation field \[fibrosis\] is permitted), and active pneumonia that are considered inappropriate by the investigator * History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * History of autoimmune disease * Positive human immunodeficiency virus (HIV) test * Severe infection within 2 weeks prior to the first dose of study treatment * Significant cardiovascular disease * History of allogeneic tissue/solid organ transplant or graft-versus-host disease * Known clinically significant liver disease

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 68, 'type': 'ESTIMATED'}}

2023-02-08