- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03710265
SHR-1701 in Metastatic or Locally Advanced Solid Tumors
November 15, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
The main purpose of this Phase I study is to access the safety and tolerability of SHR-1701 at different dose levels.
It is hoped to find out the recommended dose for Phase II/III.
Study Overview
Detailed Description
This is a Phase I, open-label trial in patients with metastatic or locally advanced solid tumor.
There are three parts of the study: a dose-escalation part, a dose-expansion part, and a clinical expansion part.
Dose escalation part is a standard "3+3" cohort design, for which 3 or 6 subjects will be enrolled at each dose level depending on the occurrence of dose-limiting toxicities (DLTs).
Dose-expansion means that at least 10 subjects (included subjects of the dose-escalation part) will be selected in 2 - 3 dose levels to focus on the pharmacokinetics (PK) / pharmacodynamic (PD) features.
After determination of the recommended dose for Phase II (RP2D), clinical expansion will be opened.
Many more subjects will be invited to take part in the study and received the study drug at the RP2D.
Additional purpose of the study is to find out whether the study drug has anti-tumor effects.
Study Type
Interventional
Enrollment (Anticipated)
206
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Linna Wang, MD
- Phone Number: +86-10-67166319
- Email: Linna.wang@hengrui.com
Study Locations
-
-
Beijing
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Beijing, Beijing, China
- Recruiting
- Beijing Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects aged between 18 and 75 years
- Life expectancy >= 12 weeks as judged by the Investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Has measurable disease per RECIST 1.1
- Subjects with confirmed metastatic or locally advanced solid tumor (histologically or cytologically) and there is no known effective anti-tumor treatment (refractory or relapsed from standard treatment).
- Adequate hematological, hepatic and renal function as defined in the protocol
- Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.
- Able to understand and sign an informed consent, and able to comply with all procedures
Exclusion Criteria:
- Anticancer treatment within 28 days before the first dose of study drug
- Major surgery within 28 days before start of trial treatment (prior diagnostic biopsy is permitted)
- 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, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded
- Subjects with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded
- Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.
- History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy, e.g., hepatitis B or C
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SHR-1701
|
Subjects will receive an intravenous infusion of SHR-1701 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
|
Screening up to study completion, an average of 1 year
|
|
Safety and tolerability profile of SHR-1701
Time Frame: Up to week 3
|
Number of Subjects who occurs dose-limiting toxicity (DLTs)
|
Up to week 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the plasma concentration versus time curve (AUC) of SHR-1701
Time Frame: Up to 4 weeks after last treatment
|
Up to 4 weeks after last treatment
|
|
Peak Plasma Concentration (Cmax) of SHR-1701
Time Frame: Up to 4 weeks after last treatment
|
Up to 4 weeks after last treatment
|
|
Half-time (t1/2) of SHR-1701
Time Frame: Up to 4 weeks after last treatment
|
Up to 4 weeks after last treatment
|
|
Pharmacodynamic features of SHR-1701
Time Frame: 12 months (anticipated)
|
SHR-1701 receptor occupation
|
12 months (anticipated)
|
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors
Time Frame: 12 months (anticipated)
|
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ¡Ý30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
|
12 months (anticipated)
|
Disease Control Rate (DCR) per RECIST 1.1
Time Frame: 12 months (anticipated)
|
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
|
12 months (anticipated)
|
Best Overall Response (BOR) per RECIST 1.1
Time Frame: 12 months (anticipated)
|
12 months (anticipated)
|
|
Immunogenicity of SHR-1701
Time Frame: 12 months (anticipated)
|
anti SHR-1603 antibodies (ADA)
|
12 months (anticipated)
|
Trough plasma concentration (C trough) of SHR-1701
Time Frame: Up to 4 weeks after last treatment
|
Up to 4 weeks after last treatment
|
|
Immunogenicity of SHR-1701
Time Frame: 12 months (anticipated)
|
12 months (anticipated)
|
|
Disease Control Rate (DCR) per RECIST 1.1
Time Frame: 12 months (anticipated)
|
12 months (anticipated)
|
|
Clinical Benefit Rate(CBR) per RECIST 1.1
Time Frame: 12 months (anticipated)
|
12 months (anticipated)
|
|
Progression-Free Survival (PFS) per RECIST 1.1
Time Frame: 12 months (anticipated)
|
12 months (anticipated)
|
|
Duration of Response (DoR) per RECIST 1.1
Time Frame: 12 months (anticipated)
|
12 months (anticipated)
|
|
Overall Survival (OS)
Time Frame: 12 months (anticipated)
|
12 months (anticipated)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 20, 2018
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
October 14, 2018
First Submitted That Met QC Criteria
October 15, 2018
First Posted (ACTUAL)
October 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 22, 2021
Last Update Submitted That Met QC Criteria
November 15, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1701-I-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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