Solid Tumor
Conditions
Keywords
SHR-1701, Solid tumor, Metastatic or locally advanced solid tumors
Brief summary
The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.
Detailed description
This is a Phase I, open-label, multiple-ascending dose trial. Study consists of dose-escalation part in subjects with metastatic or locally advanced solid tumors, and expansion part with selected indications.
Interventions
DRUGSHR-1701
Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Able and willing to provide signed informed consent form, and able to comply with all procedures. * Histologically or cytologically proven metastatic or locally advanced solid tumors. * Male or female subjects aged 18-75 years. * Life expectancy \>= 12 weeks as judged by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry. * Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply.
Exclusion criteria
* Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor. * Anticancer treatment within 28 days before the first dose of study drug. * Major surgery within 28 days before start of trial treatment. * Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment. * With any active autoimmune disease or history of autoimmune disease. * With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention. * Clinically significant cardiovascular and cerebrovascular diseases * History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy. * Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded. * Receipt of any organ transplantation, including allogeneic stem-cell transplantation Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies. | Up to 3/4 weeks. | Number of Subjects who occurs dose-limiting toxicity (DLTs). |
| Clinical expansion Part: Objective Response Rate（ORR） | Up to 6 weeks | ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical expansion Part: Safety of SHR-1701 | Up to 4 weeks after last treatment | Number of subjects who occurs treatment-related Adverse Events(AEs） |
| Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1 | Up to 6 weeks | DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1. |
| Clinical expansion Part: Duration of Response （DOR）per RECIST1.1 | Up to 6 weeks | DOR is define as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1 |
| Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1 | 12months (anticipated) | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 |
Countries
China
Outcome results
None listed