Advanced Solid Tumors
Conditions
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 or with sintilimab 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).
Interventions
DRUGSIM0348
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.
DRUGSIM0348 + Sintilimab
Selected doses from Part 1A will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks).
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Dose-limiting toxicity (DLT) | DLT evaluation window was from Baseline to the end of Cycle 1 (up to 28 days) | — |
| Part 2: Objective response rate (ORR) assessed by Investigator per RECIST v.1.1 | up to approximately 2 years | To evaluate the anti-tumor activity of SIM0348 alone and in combination with Sintilimab |
Countries
China
Outcome results
None listed