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.
In dose-escalation cohorts (Part 1), histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
In the dose-expansion cohorts (Part 2), histologically or cytologically confirmed selected advanced solid tumors.
Subjects must have at least one measurable lesion according to RECIST Version1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
Symptomatic brain metastases.
Serious non-healing wounds, ulcers or fractures.
Toxicity from previous treatment has to restore to ≤ grade 1.
Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment.
Single group
SIM0689 for Injection
DrugSIM0689 for Injection is a Programmed Cell Death Protein 1(PD1) / Vascular Endothelial Growth Factor (VEGF) bispecific antibody.
Dose-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.
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
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.
Adverse event rate
The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 6.0.
Pharmacokinetics: The area under the curve (AUC)
The area under the curve (AUC) of serum concentration of SIM0689
Pharmacokinetics: Peak concentration (Cmax)
Maximum observed concentration (Cmax) of SIM0689
Pharmacokinetics: T1/2
Terminal half-life (T1/2)
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Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Shanghai Xianwei Medical Technology Co., Ltd.
Collaborator
