SIM0613 in Participants With Advanced Solid Tumors
ConditionAdvanced Solid Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.
About this trial
This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in participants with locally advanced/ metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2).
Eligibility criteria
Qualifiers
Written informed consent (ICF) is obtained prior to any of the specified procedures required for the study
≥18 years of age
Histologically or cytologically confirmed locally advanced/metastatic solid tumors
Have at least one measurable disease per RECIST Version 1.1 criteria
Disqualifiers
Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast)
Participants with symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery), or CNS metastases requiring corticosteroids therapy within 2 weeks of first dose of study treatment.
History of bowel obstruction within 3 months prior to the first dose of study treatment.
Known psychiatric disorder or drug abuse that would interfere the study requirements
Trial design
Treatments tested in this trial
- SIM0613
- SIM0613
Treatment groups
294 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Shanghai Xianwei Medical Technology Co., Ltd.
Collaborator
Source ClinicalTrials.gov