A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Participants With Advanced Solid Tumors

NCT03666143 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: BGB-900-103CTR20181404
• Study Type: interventional
• Target: 216
• Locations: 2 countries
• Sites: 19

Brief Summary

This was an open-label, multicenter, non-randomized Phase 1b clinical trial for participants with histologically or cytologically confirmed locally advanced or metastatic tumors including non-squamous or squamous non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), ovarian cancer (OC), or melanoma.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Number of participants with treatment-emergent AEs (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs; TEAE was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study drug(s) up to 30 days following last dose of study drug(s) or initiation of a new anticancer therapy, whichever occurs first.

  Up to approximately 4 years and 2 months

Secondary Outcomes (11)

• Objective Response Rate (ORR)

  Up to approximately 4 years and 2 months

• Duration of Response (DOR)

  Up to approximately 4 years and 2 months

• Disease Control Rate (DCR)

  Up to approximately 4 years and 2 months

• Progression-free Survival (PFS)

  Up to approximately 4 years and 2 months

• Maximum Plasma Concentration (Cmax) for Sitravatinib

  Predose and up to 24 hours post dose on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 21 (C1D21); 21 days per cycle

Study Arms (1)

Sitravatinib + Tislelizumab

EXPERIMENTAL

Sitravatinib 120 mg was administered orally once daily in combination with tislelizumab 200 mg intravenously (IV) once every 3 weeks

Drug: Sitravatinib; Drug: Tislelizumab

Interventions

Sitravatinib DRUG

Administered orally as a capsule

Also known as: MGCD516

Sitravatinib + Tislelizumab

Tislelizumab DRUG

Administered intravenously

Also known as: BGB-A317, Tevimbra

Sitravatinib + Tislelizumab

Eligibility Criteria

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

You may qualify if:

• Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the Schedule of Assessments
• Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
• At least 1 measurable lesion as defined by RECIST v1.1
• Provide archival tumor tissue (formalin-fixed paraffin-embedded block \[FFPE\] with tumor tissue or unstained slides), if available.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Adequate hematologic and end-organ function
• Participants with inactive/asymptomatic carrier, chronic, or active hepatitis B virus (HBV) must have HBV deoxyribonucleic acid (DNA) \< 500 IU/mL (or 2500 copies/mL) at Screening
• Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drugs and have a negative serum pregnancy test ≤ 7 days of first dose of study drugs
• Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drugs

You may not qualify if:

• Unacceptable toxicity on prior anti-PD-1/PD-L1 treatment
• Active leptomeningeal disease or uncontrolled brain metastasis
• Active autoimmune diseases or history of autoimmune diseases that may relapse
• Any active malignancy ≤ 2 years
• Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drugs
• History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung diseases, etc.
• Severe chronic or active infections (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy, within 14 days prior to first dose of study drugs
• Known history of human immunodeficiency virus (HIV) infection
• Participants with active hepatitis C infection
• Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drugs
• Prior allogeneic stem cell transplantation or organ transplantation
• Hypersensitivity to tislelizumab or sitravatinib, to any ingredient in the formulation, or to any component of the container
• Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring within 6 months before first dose of study drugs
• Concurrent participation in another therapeutic clinical trial

Sponsors & Collaborators

• BeiGene: lead

Study Sites (19)

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, 2148, Australia

Location

Icon Cancer Foundation

South Brisbane, Queensland, 4101, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, 510080, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (3)

• Guo J, Zhou Q, Huang D, Yu X, Zhao J, Chu Q, Ma Z, Millward M, Gao B, Goh J, Markman B, Voskoboynik M, Gan H, Coward J, Chen C, Xiang X, Qui J, Xu Y, Yang L, Wu YL. A phase 1b study to assess safety, tolerability, pharmacokinetics, and preliminary antitumor activity of sitravatinib in combination with tislelizumab in patients (pts) with advanced solid tumors. Chinese Society of Clinical Oncology. 2019.

  BACKGROUND

• Zhao J, Yu X, Huang D, Ma Z, Gao B, Cui J, Chu Q, Zhou Q, Sun M, Day D, Wu J, Pan H, Wang L, Voskoboynik M, Wang Z, Liu Y, Li H, Zhang J, Peng Y, Wu YL. SAFFRON-103: a phase 1b study of the safety and efficacy of sitravatinib combined with tislelizumab in patients with locally advanced or metastatic non-small cell lung cancer. J Immunother Cancer. 2023 Feb;11(2):e006055. doi: 10.1136/jitc-2022-006055.

  PMID: 36808075 BACKGROUND

• Wang X, Pan H, Cui J, Chen X, Yoon WH, Carlino MS, Li X, Li H, Zhang J, Sun J, Guo J, Cui C. SAFFRON-103: a phase Ib study of sitravatinib plus tislelizumab in anti-PD-(L)1 refractory/resistant advanced melanoma. Immunotherapy. 2024 Mar;16(4):243-256. doi: 10.2217/imt-2023-0130. Epub 2024 Jan 10.

  PMID: 38197138 DERIVED

MeSH Terms

Interventions

sitravatinib; tislelizumab

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

1-877-828-5568

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 11, 2018
• Study Start: November 1, 2018
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: November 4, 2024
• Results First Posted: June 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (6); CN (13)