Trial of Surufatinib Combined With JS001 in the Treatment of Advanced Solid Tumors

NCT03879057 | Unknown Phase 1 DMC

• 1 other identifier: CGOG-3006/2018-012-00CH2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• adverse events

  Safety of participants followed for the duration of hospital stay, an expected average of 1 week

  1 year

• Maximum tolerated dose

  tolerability during the treatment of first cycle

  4 week

Secondary Outcomes (4)

• Objective response rate

  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)

  1 month

• Maximum Plasma Concentration (Cmax)

  8 days

• Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))

  8 days

Study Arms (2)

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.

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.

Drug: Surufatinib/humanized anti-PD-1 monoclonal antibody

Interventions

Surufatinib/humanized anti-PD-1 monoclonal antibody DRUG

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.

Also known as: Surufatinib/JS001

Surufatinib 200mg/JS001 240mg; Surufatinib 300mg/JS001 240mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35166929 DERIVED

MeSH Terms

Interventions

surufatinib

Study Officials

• Lin Shen, MD, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen

CONTACT

86-10-88196561; linshenpku@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: March 18, 2019
• Study Start: December 21, 2018
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2021
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)