A Study of SHR-7367 With Anti-tumor Agents in Patients With Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.
About this trial
This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be able and willing to provide a written informed consent.
Age 18-75 years old (inclusive) at the time of signing the informed consent form.
ECOG performance status 0-1.
Life expectancy is not less than 12 weeks.
Disqualifiers
Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures.
Known hypersensitivity to any component of SHR-7367; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination.
Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose).
Surgery or chemotherapy within 4 weeks of the first dose of study treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
SHR-7367 Injection
DrugSHR-7367 injection.
SHR-1316 Injection
DrugSHR-1316 injection.
Paclitaxel for Injection
DrugPaclitaxel for injection (Albumin Bound).
Gemcitabine Hydrochloride for Injection
DrugGemcitabine Hydrochloride for injection.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: SHR-7367 + SHR-1316 GroupExperimental treatment 2 interventions
Group B: SHR-7367 + SHR-1316 + AG GroupExperimental treatment 4 interventions
Group C: SHR-7367 + AG GroupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Stage 1 (IB Period): Dose-limiting toxicity (DLT).
Time frame
Up to 28 days.2
Stage 1 (IB Period): Adverse events (AEs).
Time frame
About 1 year.3
Stage 1 (IB Period): Serious adverse events (SAEs).
Time frame
About 1 year.4
Phase II: Investigator-assessed objective response rate (ORR).
Time frame
Assessed every 6 weeks, about 1 year.Secondary outcomes
1
Investigator-assessed objective response rate (ORR).
Complete response + Partial response (CR+PR) based on RECIST v1.1.
Time frame
Assessed every 6 weeks, about 1 year.2
Disease control rate (DCR).
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST v1.1.
Time frame
Assessed every 6 weeks, about 1 year.3
Duration of response (DoR).
Time from documentation of tumor response to disease progression assessed among patients who had an objective response.
Time frame
Assessed every 6 weeks, about 1 year.4
Progression Free Survival (PFS).
Time from C1D1 to the first assessment of disease progression or death, whichever is earlier.
Time frame
Assessed every 6 weeks, about 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov