A Study of SI-B036 in Patients With Locally Advanced or Metastatic Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.
About this trial
This study is an open-label, multicenter, non-randomized Phase I clinical study of dose-escalation and expansion to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restriction;
Age: ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Disqualifiers
Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose;
Receipt of immunosuppressive therapy within 2 weeks prior to the first dose;
History of severe cardiac or cerebrovascular disease;
QT interval prolongation, complete left bundle branch block, etc.;
Trial design
Treatments tested in this trial
- SI-B036
Treatment groups
31 Participants
are divided into 1 treatment groupLocations
1Sun Yat-sen University Cancer Center GuangzhouGuangdong, China
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov