Study of Surufatinib Single Agent or Surufatinib Combined With Toripalimab in Patients With Advanced Solid Tumors

NCT04169672 | Completed Phase 2

• 1 other identifier: 2019-012-00CH1
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase II, single arm, open-label, multicenter study to evaluate the efficacy and safety of Surufatinib single agent or Surufatinib combined with Toripalimab in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs) of safety run-in part

  The AEs of the first 6 patients were evaluated by the possibly occurs Dose Limited Toxicity (DLT).

  From Cycle 1 Day 1 to the end of Cycle 2 Day 7 (each cycle is 21 days)

• Objective response rate (ORR)

  The incidence of confirmed complete response or partial response (RECIST1.1).

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy(up to approximately 2 years)

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy(up to approximately 2 years)

• Duration of Response (DoR) (RECIST1.1 and irRECIST)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy (up to approximately 2 years)

• Progression-free Survival (PFS) (RECIST1.1 and irRECIST)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy (up to approximately 2 years)

• Disease Control Rate (DCR) (RECIST1.1 and irRECIST)

  From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy (up to approximately 2 years)

• Overall Survival (OS)

  From date of first dose of study drug until withdrawal of consent or death (up to approximately 2 years)

Study Arms (2)

Surufatinib & Toripalimab

EXPERIMENTAL

Surufatinib 250mg will be taken orally once daily continuously through a 21-day cycle of study treatment. Toripalimab 240mg will be intravenously administered on Day 1 of each cycle.

Drug: Surufatinib; Drug: Toripalimab

Surufatinib

EXPERIMENTAL

Surufatinib 300mg will be taken orally once daily continuously through a 21-day cycle of study treatment.

Drug: Surufatinib

Interventions

Surufatinib DRUG

Surufatinib is a tablet in the form of 50mg, oral, once a day.

Also known as: HMPL-012

Surufatinib; Surufatinib & Toripalimab

Toripalimab DRUG

Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.

Also known as: JS001

Surufatinib & Toripalimab

Eligibility Criteria

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

You may qualify if:

• Adequately understand the study and voluntarily sign the Informed Consent Form;
• years old;
• Histologically or cytologically confirmed advanced solid tumors (focusing on neuroendocrine neoplasmas (NENs), biliary tract cancer, gastric cancer, thyroid cancer, small cell lung cancer, non-small cell lung cancer, soft tissue sarcoma, endometrial cancer and esophageal squamous cell carcinoma, etc);
• Fail or cannot tolerate the standard therapies, or for whom no effective standard therapy is available, or refuse standard therapy;
• NSCLC cohort: no prior chemotherapy or any other systemic therapy for stage IV NSCLC with positove PD-L1 expression;
• Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale;
• Have measurable lesions (according to RECIST 1.1);
• Agree to provide histology samples;
• Lab tests within 7 days before first dose:
• Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ≥100×10\^9/L, and hemoglobin ≥9 g/dL;
• Serum total bilirubin \<1.5 times the upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 1.5 times the ULN without liver metastases; and ALT and AST ≤ 3 times ULN with liver metastases;
• Serum creatinine \<1.5 times ULN and creatinine clearance ≥50 mL/min;
• Urine protein \< 2+; if ≥2+, 24-hour urine protein \<1 g;
• International Normalized Ratio (INR) ≤1.5 ULN and activated partial thromboplastin time (APTT) ≤1.5 ULN;

You may not qualify if:

• Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for hair loss or Grade ≤ 2 peripheral neurotoxicity caused by oxaliplatin);
• Other malignancies diagnosed within the previous 5 years, except skin basal cell carcinoma or skin squamous cell carcinoma or cervical carcinoma in situ;
• Symptomatic central nervous system (CNS) metastasis or cancerous meningitis (meningeal metastasis) during the screening period;
• Systematic anti-tumor therapy received within 4 weeks prior to first dose, including chemotherapy, biotherapy, targeted therapy, hormonotherapy, and anti-tumor Chinese medicine treatment;
• Radical radiotherapy within 4 weeks prior to first dose, radioactive seed implantation within 60 days prior to first dose, or Palliative radiotherapy for a bone metastasis lesion within 1 week prior to first dose;
• Functional NENs which need to be treated with long acting Somatostatin analogues (SSAs) to control disease related syndromes, such as insulinoma, gastrinoma, glucagonoma, somatostatinoma, ACTHoma, VIPoma, accompanied by carcinoid syndrome, Zollinger-Ellison syndrome or other active symptoms;
• Previously treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, any other antibody acting on the T cell stimulation or checkpoint pathway or Surufatinib;
• Previously received anti-VEGF/VEGFR targeted drugs and progressed during the treatment or within 4 months after these drugs;
• Thyroid dysfunction with symptoms or require treatment when screening except hypothyroidism controlled only by thyroid hormone replacement therapy, the level of TSH in patients with iodine refractory differentiated thyroid cancer is more than 0.1 mU/L (or other corresponding unit level) before the beginning of the study treatment;
• Previously received immunosuppressive drugs except locally or temporarily used glucocorticoids;
• Autoimmune disease with systematic treatment or autoimmune disease history within 2 years;
• Previously received systematic immunologic stimulants within 4 weeks prior to the first dose;
• Inoculated with any live vaccine or attenuated live vaccine within 4 weeks or planed to inoculate during the study;
• Major surgery within 4 weeks or unhealed wound/fracture;
• Uncontrolled malignant hydrothorax, ascites, or pericardial effusion;

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

• Zhang P, Chen Z, Shi S, Li Z, Ye F, Song L, Zhang Y, Yin F, Zhang X, Xu J, Cheng Y, Su W, Shi M, Fan S, Tan P, Zhong C, Lu M, Shen L. Efficacy and safety of surufatinib plus toripalimab, a chemotherapy-free regimen, in patients with advanced gastric/gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, or biliary tract cancer. Cancer Immunol Immunother. 2024 May 7;73(7):119. doi: 10.1007/s00262-024-03677-7.

  PMID: 38713205 DERIVED

• Zhang P, Shi S, Xu J, Chen Z, Song L, Zhang X, Cheng Y, Zhang Y, Ye F, Li Z, Yin F, Ji D, Gao H, Li Y, Chen W, Yang M, Weng D, Wu C, Ma Y, Sheng W, Zhao Y, Yin X, Shen W, Su W, Shi M, Fan S, Tan P, Xu Q, Lu M, Shen L. Surufatinib plus toripalimab in patients with advanced neuroendocrine tumours and neuroendocrine carcinomas: An open-label, single-arm, multi-cohort phase II trial. Eur J Cancer. 2024 Mar;199:113539. doi: 10.1016/j.ejca.2024.113539. Epub 2024 Jan 15.

  PMID: 38237373 DERIVED

MeSH Terms

Interventions

surufatinib; toripalimab

Study Officials

• Lin Shen

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: December 26, 2019
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)