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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05718219
• Other study ID #: SIM0348-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2023
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Li Zhang
• Phone: 86-20-8734-3894
• Email: zhangli[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)	Part 1	DLT evaluation window was from Baseline to the end of Cycle 1 (up to 28 days)
Primary	Objective response rate (ORR) assessed by Investigator per RECIST v.1.1	Part 2: To evaluate the anti-tumor activity of SIM0348	up to approximately 2 years