Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Escalating Doses of SIM0348 as a Single Agent in Advanced Solid Tumors
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Part 1 (dose escalation and dose expansion) 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. |
Drug: SIM0348
Several dose levels will be evaluated for SIM0348 administered as a single agent . SIM0348 will be given via IV infusion on Day 1,Day 8,Day 15,Day 22 of each cycle (28-day or depending on study cohort and phase) until disease progression or loss of clinical benefit.
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Experimental: Part 2 (cohort expansion) Participants will be treated with SIM0348 at a recommended dose (RD) in the study. |
Drug: SIM0348
Several dose levels will be evaluated for SIM0348 administered as a single agent . SIM0348 will be given via IV infusion on Day 1,Day 8,Day 15,Day 22 of each cycle (28-day or depending on study cohort and phase) until disease progression or loss of clinical benefit.
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Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults 18 years of age or older
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Must have failed at least one established standard anti-cancer therapies
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Life expectancy at least 12 weeks
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Adequate hematologic and end organ function
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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
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Confirmed availability of representative tumor specimens
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Measurable disease according to RECIST Version 1.1
Exclusion Criteria:
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Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1
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Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
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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
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History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
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History of autoimmune disease
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Positive human immunodeficiency virus (HIV) test
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Severe infection within 2 weeks prior to the first dose of study treatment
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Significant cardiovascular disease
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History of allogeneic tissue/solid organ transplant or graft-versus-host disease
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Known clinically significant liver disease
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SIM0348-101