Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors

A Multicenter, Open-label, Exploratory Phase II Clinical Study to Evaluate the Safety and Tolerability and Preliminary Efficacy of TJ107 Combine With Pembrolizumab Injection in Patients With Locally Advanced or Metastatic Solid Tumors

Study Purpose and Design:A Multicenter, Open-label, Exploratory Phase II Clinical Study to Evaluate the Safety and Tolerability and Preliminary Efficacy of TJ107 in Combination with Pembrolizumab Injection in Patients with Locally Advanced or Metastatic Solid Tumors

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma; Triple-negative Breast Cancer
• Intervention / Treatment: Biological: TJ107 +Pembrolizumab

Detailed Description

This open-label, multicenter phase 2 study will enroll 28 to 39 subjects in each of the following 4 cohorts Cohort 1 Triple-negative breast cancer Cohort 2 Head and neck squamous cell carcinoma Cohort 3 Other tumor species (to be determined) Cohort 4 Other tumor species (to be determined) The trial consists of two phases, the first is a safety run-in phase and the second is a case extension phase.

In the safety run-in phase, 3 subjects will be treated with TJ107 (1200 µg/kg q12w) combined with Pembrolizumab Injection (200 mg q3w) first. A safety assessment was conducted by a safety assessment committee composed of the sponsor and the investigator on the first dose in these 3 subjects to determine that the dose of TJ107 1200 µg/kg was safe and to determine whether to continue the safety assessment in these 3 patients, either at this dose level, or at a dose or dosing interval adjustment (e.g., the dose of TJ107 was adjusted to 960 ug/kg or the dosing interval was adjusted).

In the case expansion phase, 28-39 subjects will be enrolled in each cohort, and TJ107 (1200 µg/kg q12w) combined with Pembrolizumab Injection (200 mg q3w) or TJ107 adjusted dose combined with Pembrolizumab Injection (200 mg q3w) will be administered until intolerance or disease progression and other endpoint events occur.

• Study Type: Interventional
• Enrollment (Estimated): 133
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Guangzhou
    • Shenzhen, Guangzhou, China
      • Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center
  • Hainan
    • Haikou, Hainan, China
      • Hainan General Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Harbin Medical University Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China
      • Tongji Hospital, Tongji Medical College of Huzhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South University
  • Jilin
    • Chang chun, Jilin, China
      • Jilin Guowen Hospital
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
    • Changchun, Jilin, China
      • Jilin Cancer Hospital
    • Yanji, Jilin, China
      • Yanbian University Hospital
  • Liaoning
    • Shenyang, Liaoning, China
      • The First Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China
      • Shanghai East Hospital
    • Shanghai, Shanghai, China
      • Shanghai ninth People's Hospital,Shanghai Jiaotong University School of Medicine
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Institute & Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female patients aged over 18 years (inclusive);
• ECOG score: 0 - 2 points
• Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors, including TNBC and HNSCC
• No previous treatment with CPI
• Agreement to provide a previously archived tumor tissue specimen or biopsy to collect tumor lesion tissue
• Subject has at least 1 measurable lesion as defined by RECIST V1.1
• Expected survival ≥ 6 months
• Adequate organ function
• Males of childbearing potential or females of childbearing potential must use highly effective contraceptive methods during the trial and continuing for 6 months after the last dose
• The subject voluntarily joined the study and signed an informed consent form

Exclusion Criteria:

• Pregnant or lactating women;
• Prior cell therapy;
• Received systemic anti-tumor therapy within 2 weeks or 5 half-lives of the treatment agent (whichever is shorter) before the start of treatment;
• Previous or current presence of two or more primary tumors
• Patients with active autoimmune diseases
• Have received systemic treatment with corticosteroids (10 mg prednisone equivalent daily) or other immunosuppressive agents for more than 7 days within 2 weeks before the start of treatment
• Received investigational drugs within 2 weeks before the start of treatment;
• Major surgery or serious trauma within 4 weeks before the start of treatment;
• Patients with symptomatic central nervous system (CNS) metastasis
• Active viral infectious disease requiring systemic treatment at screening:
• Known serious hypersensitivity history
• Uncontrolled pleural effusion, ascites, or pericardial effusion at screening;
• Presence or history of active interstitial lung disease;
• Patients with hypertension that cannot be well controlled with medical therapy.
• Presence of clinically significant cardiovascular disease
• Deep venous thrombosis within 6 months before the start of treatment
• Thrombolytic therapy within 10 days prior to the start of treatment
• Any active infection requiring intravenous anti-infective therapy before the start of treatment
• Had toxicity not resolved to ≤ Grade 1 (CTCAE 5.0) from previous anticancer therapy
• Known or suspected inability to comply with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TJ107+Pembrolizumab; TJ107 1200ug/Kg,Q12W + Pembrolizumab 200mg Q3W	Biological: TJ107 +Pembrolizumab; TJ107 injection:1200ug/Kg, Q12W, IM; Pembrolizumab: 200mg, Q3W, IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of Adverse events	The rate of Adverse events	Through the study assessed up to 2 years
The rate of Senior Adverse Events	The rate of Senior Adverse Events	Through the study assessed up to 2 years

Collaborators and Investigators

• Sponsor: TJ Biopharma Co., Ltd.
• Investigators: Study Director: Liyang Song, Master, I-Mab Biopharma Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Solid Tumors; Head and neck squamous cell carcinoma; Triple-negative breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Breast Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab
• Other Study ID Numbers: TJ107001STM202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No