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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SHR-1501, Adebrelimab
Drugthe combination of SHR-1501 and Adebrelimab
Treatment groups
203 Participants
are divided into 1 treatment groupGroup A: the combination of SHR-1501 and AdebrelimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity
evaluate the safety in the doses escalation
Time frame
21 Days or 28 days2
Maximum tolerated dose or Maximum-administered dose
evaluate the safety in the doses escalation
Time frame
Approximately 1 years3
Recommended Phase 2 dose (RP2D)
evaluate the safety and curative effect in the doses escalation
Time frame
Approximately 2years.4
Objective response rate(ORR)
Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab
Time frame
Approximately 2 yearsSecondary outcomes
1
Maximum concentration (Cmax) of SHR-1501
To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab
Time frame
Approximately 2 years2
Time to maximum concentration (Tmax) of SHR-1501
To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab
Time frame
Approximately 2 years3
Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1501
To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab
Time frame
Approximately 2 years4
Steady-state valley concentration (Cmin)of SHR-1501
To evaluate the pharmacokinetic characteristics of Steady-state valley concentration
Time frame
Approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov