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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05145907
• Other study ID #: TJ107001STM202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 22, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: TJ Biopharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer

Intervention

Biological:
• TJ107 +Pembrolizumab
TJ107 injection:1200ug/Kg, Q12W, IM; Pembrolizumab: 200mg, Q3W, IV

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
TJ Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of Adverse events	The rate of Adverse events	Through the study assessed up to 2 years
Primary	The rate of Senior Adverse Events	The rate of Senior Adverse Events	Through the study assessed up to 2 years