Status:
UNKNOWN
SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 o...
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 indi...
Eligibility Criteria
Inclusion
- 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
- 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 exclusion criteria could apply
Key Trial Info
Start Date :
January 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT03774979
Start Date
January 24 2019
End Date
December 1 2023
Last Update
November 8 2022
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Anhui Chest Hospital-Departmen of Tumor Radiotherapy
Hefei, Anhui, China
2
The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center
Guangzhou, Guangzhou, China
3
Xinxiang Central Hospital-Department of Respiratory Physicians
Xinxiang, Henan, China
4
The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology
Zhengzhou, Henan, China