Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.
About this trial
This study is an open, multicenter phase I/II clinical study. The entire study is divided into three stages: dose escalation, dose expansion, and efficacy expansion. Objective: To evaluate the objective response rate (ORR), safety and tolerability of the combination of SHR-1501 and adibelizumab in the treatment of advanced malignant tumors, and to provide the recommended dose (RP2D) for subsequent clinical studies.
Eligibility criteria
Qualifiers
Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in person.
Age: 18 to 75 years old (including both ends), gender not limited.
Subjects with locally advanced or metastatic solid tumors that have been histologically or cytologically confirmed to be inoperable for radical surgery or radical chemoradiotherapy, whose disease progresses after standard treatment, or who have no standard treatment plan, or are not suitable for standard treatment.
According to the efficacy evaluation criteria for Solid tumors (RECIST 1.1), there is at least one measurable lesion;
Disqualifiers
Symptomatic or active central nervous system (CNS) tumor metastasis;
Other malignant tumors within five years before the first use of study drugs;
Uncontrolled tumor-related pain judged by the investigator;
Severe cardiovascular and cerebrovascular diseases;
Trial design
Treatments tested in this trial
- SHR-1501, Adebrelimab
Treatment groups
203 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov