Solid Tumor
Conditions
Brief summary
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).
Interventions
DRUGSHR-7367 Injection
SHR-7367 injection.
SHR-1316 injection.
Paclitaxel for injection (Albumin Bound).
DRUGGemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Be able and willing to provide a written informed consent. 2. Age 18-75 years old (inclusive) at the time of signing the informed consent form. 3. ECOG performance status 0-1. 4. Life expectancy is not less than 12 weeks. 5. At least one measurable lesion per RECIST v1.1. 6. Adequate organ and marrow function as defined by the protocol.
Exclusion criteria
1. 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. 2. 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. 3. 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). 4. Surgery or chemotherapy within 4 weeks of the first dose of study treatment. 5. Active HBV/HCV/HIV infection. 6. Untreated and/or uncontrolled brain metastases. 7. Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1 (IB Period): Dose-limiting toxicity (DLT). | Up to 28 days. |
| Stage 1 (IB Period): Adverse events (AEs). | About 1 year. |
| Stage 1 (IB Period): Serious adverse events (SAEs). | About 1 year. |
| Phase II: Investigator-assessed objective response rate (ORR). | Assessed every 6 weeks, about 1 year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed objective response rate (ORR). | Assessed every 6 weeks, about 1 year. | Complete response + Partial response (CR+PR) based on RECIST v1.1. |
| Incidence and severity of Adverse events (AEs). | Assessed approximately once every 1 month, about 1 year. | Time from C1D1 to the first assessment of disease progression or death, whichever is earlier. |
| Disease control rate (DCR). | Assessed every 6 weeks, about 1 year. | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST v1.1. |
| Duration of response (DoR). | Assessed every 6 weeks, about 1 year. | Time from documentation of tumor response to disease progression assessed among patients who had an objective response. |
| Progression Free Survival (PFS). | Assessed every 6 weeks, about 1 year. | Time from C1D1 to the first assessment of disease progression or death, whichever is earlier. |
Countries
China
Contacts
Primary ContactBotao Zhu
Outcome results
None listed