Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Escalating Doses of SIM0348 as a Single Agent in Advanced Solid Tumors
- Registration Number
- NCT05718219
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2 (cohort expansion) SIM0348 Participants will be treated with SIM0348 at a recommended dose (RD) in the study. Part 1 (dose escalation and dose expansion) SIM0348 Cohorts of at least 3 participants each will be treated with escalating doses of SIM0348. Dose expansion part will be decided based on the findings of dose escalation part.
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity (DLT) DLT evaluation window was from Baseline to the end of Cycle 1 (up to 28 days) Part 1
Objective response rate (ORR) assessed by Investigator per RECIST v.1.1 up to approximately 2 years Part 2: To evaluate the anti-tumor activity of SIM0348
- Secondary Outcome Measures
Name Time Method