Solid TumorPhase 1NCT03879057
Trial of Surufatinib Combined With JS001 in the Treatment of Advanced Solid Tumors
A Phase 1 study testing Surufatinib/humanized anti-PD-1 monoclonal antibody in people with Solid Tumor, run by Peking University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Surufatinib/humanized anti-PD-1 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2018to 20 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, 86-10-88196561, linshenpku@163.com
About this study
Official title: 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.
- Conditions
- Solid Tumor
- Being tested
- Surufatinib/humanized anti-PD-1 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib/humanized anti-PD-1 monoclonal antibodyDrug
Also called Surufatinib/JS001
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.
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib 200mg/JS001 240mg | Experimental | 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. Receives: Drug: Surufatinib/humanized anti-PD-1 monoclonal antibody |
| Surufatinib 300mg/JS001 240mg | Experimental | 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. Receives: Drug: Surufatinib/humanized anti-PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Safety of participants followed for the duration of hospital stay, an expected average of 1 week
Measured: 1 year
Maximum tolerated dose
tolerability during the treatment of first cycle
Measured: 4 week
Secondary outcomes (4)
Objective response rate
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))
Measured: 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)
From date of enrollment until the date of tumor progression
Measured: 1 month
Maximum Plasma Concentration (Cmax)
Pharmacokinetic profile in terms of observed maximum plasma concentration
Measured: 8 days
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
Pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf)
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start21 Dec 2018
- Primary completion20 Dec 2020 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, MD, PhD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879057
- Sponsor's protocol ID
- CGOG-3006/2018-012-00CH2
- Status last verified
- Sep 2019
- First submitted
- 28 Dec 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao Y, Lu M, Sun Y, Gong J, Li J, Lu Z, Li J, Zhang X, Li Y, Peng Z, Zhou J, Wang X, Shen L. Surufatinib plus toripalimab in patients with advanced solid tumors: a single-arm, open-label, phase 1 trial. J Cancer Res Clin Oncol. 2023 Feb;149(2):779-789. doi: 10.1007/s00432-021-03898-8. Epub 2022 Feb 15.
PubMed 35166929
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surufatinib Combined With JS001 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03879057
- Acronym / sponsor ID
- CGOG-3006/2018-012-00CH2
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surufatinib 200mg/JS001 240mg | Experimental | Drug: Surufatinib/humanized anti-PD-1 monoclonal antibodySurufatinib 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. |
| Surufatinib 300mg/JS001 240mg | Experimental | Drug: Surufatinib/humanized anti-PD-1 monoclonal antibodySurufatinib 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surufatinib/humanized anti-PD-1 monoclonal antibodyAlso: Surufatinib/JS001humanized 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. | Drug | Surufatinib 200mg/JS001 240mg, Surufatinib 300mg/JS001 240mg |
Primary outcome
adverse events
Time frame: 1 year
Safety of participants followed for the duration of hospital stay, an expected average of 1 week
Maximum tolerated dose
Time frame: 4 week
tolerability during the treatment of first cycle
4 secondary outcomes
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
time to treatment failure(TTF)
Time frame: 1 month
Maximum Plasma Concentration (Cmax)
Time frame: 8 days
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Derived from this study: PubMed 35166929Cao Y, Lu M, Sun Y, Gong J, Li J, Lu Z, Li J, Zhang X, Li Y, Peng Z, Zhou J, Wang X, Shen L. Surufatinib plus toripalimab in patients with advanced solid tumors: a single-arm, open-label, phase 1 trial. J Cancer Res Clin Oncol. 2023 Feb;149(2):779-789. doi: 10.1007/s00432-021-03898-8. Epub 2022 Feb 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Shen, MD, PhD principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Surufatinib/humanized anti-PD-1 monoclonal antibody in people with Solid Tumor, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.