- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879057
Trial of Surufatinib Combined With JS001 in the Treatment of Advanced Solid Tumors
September 27, 2019 updated by: Shen Lin, Peking University
Phase I Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surufatinib Combined With JS001 in Patients With Advanced Solid Tumors
This is an open-label, phase I study evaluating safety, tolerability, pharmacokinetics and efficacy of Surufatinib combined with the humanized anti-PD-1 antibody JS001 in patients with solid tumors.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
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 Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- 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:
- Must have read, understood, and provided written informed consent voluntarily. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
- Male and Female aged between 18 and 75 years are eligible;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Histologic diagnosis of locally advanced or metastatic unresectable solid tumors (neuroendocrine tumors, liver carcinoma, gastric carcinomas considered with priority);
- Failed after standard treatment (disease progression or intolerable for toxic side effects) or no effective to treatment;
- For liver carcinoma with Child-Pugh of grade A and grade B (≤ 7 points);
- Radiographic evidence of disease rogression by RECIST criteria on or after last anti-cancer therapy within 6 months; If the single lesion previously received radiation, ablation, there must be an imaging identification for disease progression;
- Predicted survival >=3 months;
- At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
- Screening laboratory values must meet the following criteria (within past 14 days): hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN, creatinine clearance >50ml/min (CockcroftGault equation) PT/INR, aPTT≤1.5 x ULN;
- Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 12 months after the last dose of study drug.
Exclusion Criteria:
- The toxicity associated with previous anti-tumor treatment has not recovered to ≤CTCAE1, except for peripheral neurotoxicity and alopecia ≤CTCAE2 caused by oxaliplatin;
- Had other malignant tumors in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled);
- Evidence with active CNS disease;
- Prior treatment with chemotherapy, biological immunotherapy, targeted therapy, Chinese herbal medicine within 2 weeks.
- Prior treatment with radical radiation within 4 weeks
- Prior treatment with antiPD1/PDL1/PDL2/CTLA-4 antibody or Sulfatinib;
- Prior treatment with corticosteroids (dose > 10 mg/day prednisone or other hormones) or other immunosuppressive agents within 2 weeks, nasal or inhalation in allowed (dose > 10 mg/day prednisone or other hormones).
- Patients with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism;
- Prior live vaccine therapy within past 4 weeks;
- Prior major surgery within past 4 weeks (diagnostic surgery excluded);
- Uncontrolled malignant pleural effusion, ascites or pericardial effusion;
- Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg;
- The patient currently has disease or condition that affects the absorption of the drug, or the patient cannot be administered orally;
- Received a potent inducer or inhibitor of CYP3A4 within 2 weeks, or continue receiving these drugs during the study;
- Digestive tract disease such as gastric and duodenal active ulcer, ulcerative colitis or unresected tumor, or other conditions determined by the investigator that may cause gastrointestinal bleeding and perforation;
- Evidence of bleeding tendency or history within 2 months, or thromboembolic event (including a stroke event and/or a transient ischemic attack) occurred within 12 month;
- Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including active severe infection, uncontrolled diabetes, angiocardiopathy (heart failure > class II NYHA, LVEF <50%, myocardial infarction, unstable arrhythmia or unstable angina within past 6 months, cerebral infarction within past 3 months) or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
- Clinically significant severe electrolyte abnormality judged by investigator ;
- Active infection or unexplained fever during the screening period (temperature >38.5C)
- History with tuberculosis who are receiving or have received anti-TB treatment within 1 year.
- Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severe impaired lung function, etc; Radiation pneumonitis in the radiotherapy area is allowed;
- Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>2000IU/ml);
- Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
- Pregnant or nursing;
- Hypersensitivity to Sulfatinib or recombinant humanized antiPD1 monoclonal Ab;
- Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Surufatinib 200mg/JS001 240mg
Surufatinib at a dose of 200mg Qd, with humanized anti-PD-1 monoclonal antibody(JS001) injected intravenously 240mg per 3 weeks until disease progresses or unacceptable tolerability occurs.
|
humanized anti-PD-1 monoclonal antibody(JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with th combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activitation of lymphocytes and elimination of malignancy theoretically.
Other Names:
|
EXPERIMENTAL: Surufatinib 300mg/JS001 240mg
Surufatinib at a dose of 300mg Qd, with humanized anti-PD-1 monoclonal antibody(JS001) injected intravenously 240mg per 3 weeks until disease progresses or unacceptable tolerability occurs.
|
humanized anti-PD-1 monoclonal antibody(JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with th combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activitation of lymphocytes and elimination of malignancy theoretically.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse events
Time Frame: 1 year
|
Safety of participants followed for the duration of hospital stay, an expected average of 1 week
|
1 year
|
Maximum tolerated dose
Time Frame: 4 week
|
tolerability during the treatment of first cycle
|
4 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
|
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%).
In the event of PR or CR, the subjects should confirm it no less than 4 weeks after the first evaluation.
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1(each cycle is 21 days))
|
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
|
time to treatment failure(TTF)
Time Frame: 1 month
|
From date of enrollment until the date of tumor progression
|
1 month
|
Maximum Plasma Concentration (Cmax)
Time Frame: 8 days
|
Pharmacokinetic profile in terms of observed maximum plasma concentration
|
8 days
|
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
Time Frame: 8 days
|
Pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf)
|
8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 21, 2018
Primary Completion (ANTICIPATED)
December 20, 2020
Study Completion (ANTICIPATED)
December 20, 2021
Study Registration Dates
First Submitted
December 28, 2018
First Submitted That Met QC Criteria
March 15, 2019
First Posted (ACTUAL)
March 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 1, 2019
Last Update Submitted That Met QC Criteria
September 27, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGOG-3006/2018-012-00CH2
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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