This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic Solid Tumors. The study has a dose escalation part to find the highest dose that can be given safely, or recommended dose (RD) for SIM0689 when given alone, and a dose expansion part in subjects with specific tumor types treated with SIM0689 as a single agent at RD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
472
SIM0689 for Injection is a Programmed Cell Death Protein 1(PD1) / Vascular Endothelial Growth Factor (VEGF) bispecific antibody.
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
NOT_YET_RECRUITINGCancer Hospital of Shandong First Medical University
Jinan, Shandong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital, Zhejiang University school of Medicine
Hangzhou, Zhejiang, China
RECRUITINGDose-limiting toxicity (DLT) (Dose escalation)
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria.
Time frame: at the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose (MTD)and / or Recommended dose (RD) (Dose escalation)
The MTD is defined as the dose of SIM0689 with an estimated toxicity rate closest to the target toxicity rate of 27%; RD stands for Recommended Dose, which will be selected based on the evaluation of all available pharmacokinetics, pharmacodynamic, efficacy, safety, and tolerability data
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) (Dose expansion)
ORR is the proportion of participants with complete response(CR)or partial response (PR) assessed according to RECIST v1.1.
Time frame: Up to approximately 2 years
Adverse event rate
The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 6.0.
Time frame: up to approximately 2 years
Pharmacokinetics: The area under the curve (AUC)
The area under the curve (AUC) of serum concentration of SIM0689
Time frame: up to approximately 2 years
Pharmacokinetics: Peak concentration (Cmax)
Maximum observed concentration (Cmax) of SIM0689
Time frame: Up to approximately 2 years
Pharmacokinetics: T1/2
Terminal half-life (T1/2)
Time frame: Up to approximately 2 years
Pharmacokinetics: Tmax
Time to maximum concentration
Time frame: Up to approximately 2 years
Immunogenicity
Titer of serum anti-SIM0689 antibodies
Time frame: Up to approximately 2 years
Immunogenicity
Incidence rate of serum anti-SIM0689 antibodies
Time frame: Up to approximately 2 years
Immunogenicity
Duration of serum anti-SIM0689 antibodies
Time frame: Up to approximately 2 years
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