NCT03879057
Unknown
Phase 1
Phase I Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surufatinib Combined With JS001 in Patients With Advanced Solid Tumors
Peking University1 site in 1 country24 target enrollmentDecember 21, 2018
ConditionsSolid Tumor
InterventionsSurufatinib/humanized anti-PD-1 monoclonal antibody
Overview
- Phase
- Phase 1
- Intervention
- Surufatinib/humanized anti-PD-1 monoclonal antibody
- Conditions
- Solid Tumor
- Sponsor
- Peking University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose
- Last Updated
- 6 years ago
Overview
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.
Investigators
Shen Lin
MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
Peking University
Eligibility Criteria
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;
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);
Arms & Interventions
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.
Intervention: Surufatinib/humanized anti-PD-1 monoclonal antibody
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.
Intervention: Surufatinib/humanized anti-PD-1 monoclonal antibody
Outcomes
Primary Outcomes
Maximum tolerated dose
Time Frame: 4 week
tolerability during the treatment of first cycle
adverse events
Time Frame: 1 year
Safety of participants followed for the duration of hospital stay, an expected average of 1 week
Secondary Outcomes
- 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 Sites (1)
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