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

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

NCT ID: NCT05718219

Condition: Advanced Solid Tumors

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SIM0348
Description: 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.
Arm group label: Part 1 (dose escalation and dose expansion)

Intervention type: Drug
Intervention name: SIM0348
Description: 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.
Arm group label: Part 2 (cohort expansion)

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).

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: April 1, 2023

Completion date: December 30, 2025

Lead sponsor:
Agency: Jiangsu Simcere Pharmaceutical Co., Ltd.
Agency class: Industry

Source: Jiangsu Simcere Pharmaceutical Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05718219