Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Escalating Doses of SIM0348 as a Single Agent in Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Criteria

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