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Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04579757
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
BeiGene
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Brief Summary:
This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2).

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumor Colorectal Cancer Neuroendocrine Tumors Small Cell Lung Cancer Gastric Cancer Soft Tissue Sarcoma Drug: Surufatinib and Tislelizumab _ Part 1 Drug: Surufatinib and Tislelizumab _ Part 2 Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2).

Part 1 will be conducted to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of surufatinib in combination with tislelizumab in patients with advanced or metastatic solid tumors who have progressed on, or are intolerant to standard therapies.

Part 2 will be an open-label, multi-cohort design to evaluate the anti-tumor activity of surufatinib in combination with tislelizumab in patients with specific types of advanced or metastatic solid tumors. Patients will receive the RP2D determined in part 1 of this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase Ib/II Study of Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
Actual Study Start Date : March 5, 2021
Estimated Primary Completion Date : February 27, 2023
Estimated Study Completion Date : April 30, 2023


Arm Intervention/treatment
Experimental: Surufatinib and tislelizumab (dose escalation_Part 1)
In Part 1 (dose escalation), surufatinib and will be administered orally (PO) once daily (QD) and tislelizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W).
Drug: Surufatinib and Tislelizumab _ Part 1
Part 1 (all cohorts): oral surufatinib at a dose based on cohort level and intravenous tislelizumab at a 200-mg dose
Other Name: HMPL-012, sulfatinib, BGB-A317

Experimental: Surufatinib and tislelizumab (indication specific_Part 2)
In Part 2, the indication-specific expansion portion of the study, patients will receive surufatinib at the Recommended Phase 2 Dose (RP2D) dose selected in Part 1 with 200 mg tislelizumab IV, Q3W
Drug: Surufatinib and Tislelizumab _ Part 2
Part 2 (all cohorts): oral surufatinib at the RP2D dose selected in Part 1 and intravenous tislelizumab at a 200-mg dose
Other Name: HMPL-012, sulfatinib, BGB-A317




Primary Outcome Measures :
  1. Incidence of dose limiting toxicity [ Time Frame: up to 60 days ]
    The primary outcome during dose escalation will be the incidence rate of dose limiting toxicities

  2. Objective response rate (ORR) [ Time Frame: up to 2 years ]
    The primary outcome of dose expansion will be objective response rate (ORR) in patients with advanced solid tumors when treated with surufatinib in combination with tislelizumab in each cohort


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: up to 6 months ]
    the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).

  2. Maximum plasma concentrations of surufatinib and tislelizumab with blood sampling [ Time Frame: up to 18 months ]
    Blood samples will be taken to measure levels of study drug

  3. To evaluate the safety, in subjects, treated with surufatinib and tislelizumab [ Time Frame: up to 2 years ]
    Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  4. Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]
    The incidence of complete response, partial response and stable disease

  5. Duration of Response (DoR) [ Time Frame: up to 24 months ]
    The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded

  6. Clinical Benefit Rate (CBR) [ Time Frame: Up to 24 months ]
    The incidence of partial response and stable disease

  7. Time to Response (TTR) [ Time Frame: up to 24 months ]
    The period from the date of enrollment to the date when the criteria for complete response or partial response was first measured (first record shall prevail).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide informed consent
  2. ≥18 years of age
  3. Part 1-have evaluable lesions (according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1])
  4. Part 2-have measurable lesions (according to RECIST v1.1)
  5. Have a performance status of 0 or 1 on the ECOG scale
  6. For female subjects of childbearing potential and male patients with partners of childbearing potential, agreement to use a highly effective form(s) of contraception

    Dose Escalation:

  7. Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type,.

    Dose Expansion:

  8. Histologically or cytologically documented, locally advanced or metastatic:

Cohort A: adenocarcinoma of the colon or rectum that is microsatellite stable. Subjects must have progressed on, or had intolerable toxicity to, at least 3 prior regimens of standard chemotherapy.

Cohort B: progressive, low or intermediate grade (grade 1 or grade 2) NETs of thoracic or GEP origins. Subjects must have radiological documentation of progression of disease in the last 6 months and must have progressed on at least one line of standard therapy for metastatic disease.

Cohort C: SCLC that has progressed on standard first line chemotherapy treatment.

Cohort D: adenocarcinoma of the stomach or gastroesophageal junction and have progressed on at least 2 prior lines of therapy. Tumor stain for PD-L1 by Combined Positive Score (CPS) ≥5%.

Cohort E: ASPS or UPS. Subjects must have radiological documentation of disease progression in the last 3 months and have progressed on at least one line of standard therapy or refused standard frontline cytotoxic chemotherapy.

Exclusion Criteria:

  1. Adverse events (AEs) due to previous anti-tumor therapy has not recovered to Common Terminology Criteria for Adverse Event (CTCAE) ≤Grade 1;
  2. Part 2 subjects with CRC , NETs and STS any previous treatment with anti-PD-1, anti PD-L1/L2 antibodies, anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody, or any other antibody acting on T cell costimulatory or checkpoint pathway;
  3. Previous treatment with surufatinib;
  4. Uncontrollable hypertension;
  5. History or presence of a serious hemorrhage (>30 ml within 3 months), hemoptysis (>5 ml blood within 4 weeks) or life threatening thromboembolic event within 6 months;
  6. Clinically significant cardiovascular disease;
  7. Any clinically significant active infection, including, but not limited to, known human immunodeficiency virus (HIV) infection;
  8. Brain metastases and/or leptomeningeal disease and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of SD for 14 days or longer; subjects requiring steroids within 4 weeks prior to start of study treatment will be excluded;
  9. Active autoimmune diseases or history of autoimmune diseases that may relapse with the following exceptions:

    1. Controlled Type 1 diabetes
    2. Hypothyroidism (provided it is managed with hormone-replacement therapy only)
    3. Controlled celiac disease
    4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
    5. Any other disease that is not expected to recur in the absence of external triggering factors.
  10. Arterial thrombosis or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months prior to first dosing;
  11. History of deep venous thrombosis within 6 months;
  12. Female patients who are pregnant or breastfeeding;
  13. Any condition by which investigators judge patients not suitable to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579757


Contacts
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Contact: Leslie Callahan 973-826-5578 lesliec@hmplglobal.com
Contact: Chris Tucci 973-786-2634 Christucci@hmplglobal.com

Locations
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United States, Colorado
Rocky Mountain Cancer Centers Midtown Recruiting
Denver, Colorado, United States, 80218
Contact: Jennifer Hege       Jennifer.hege@usoncology.com   
Contact: Allen Cohn, MD    (303)388-4876      
United States, South Carolina
Prisma Health - Upstate (ITOR) Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jean Moore    864-455-3600    Jean.moore@prismahealth.org   
Principal Investigator: Ki Chung, MD         
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: Fernando Bravo    214-545-3890    FBravo@marycrowley.org   
Contact: James Strauss, MD    972-566-3000    jstrauss@marycrowley.org   
Principal Investigator: James Strauss, MD         
Texas Oncology - Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Jennifer M Wright    469-324-8318    jennifer.wright2@usoncology.com   
Contact: Andrew S Paulson, MD       Scott.Paulson@USONCOLOGY.COM   
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Marcy Sullivan         
Sponsors and Collaborators
Hutchison Medipharma Limited
BeiGene
Investigators
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Study Director: John Kauh, MD Hutchison
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT04579757    
Other Study ID Numbers: 2020-012-GLOB1
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hutchison Medipharma Limited:
VEGF
PD-1
Additional relevant MeSH terms:
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Neoplasms
Sarcoma
Small Cell Lung Carcinoma
Neuroendocrine Tumors
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue