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Triple-negative Breast CancerPhase 2NCT05145907

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

A Phase 2 study testing TJ107 +Pembrolizumab in people with Triple-negative Breast Cancer and Head and Neck Squamous Cell Carcinoma, run by TJ Biopharma Co., Ltd. at 20 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TJ107 +Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
20 sitesChina
Study dates
22 Dec 2021to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

  • Jilin Cancer Hospital

    Changchun, Jilin

  • Jilin Guowen Hospital

    Changchun, Jilin

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Hainan General Hospital

    Haikou, Hainan

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, Guangzhou

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Tongji Hospital, Tongji Medical College of Huzhong University of Science and Technology

    Wuhan, Hubei

  • Yanbian University Hospital

    Yanji, Jilin

Other trials in China

About this study

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

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

Read the 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.

Being tested
TJ107 +Pembrolizumab
Keywords
Triple-negative breast cancer, Head and neck squamous cell carcinoma, Solid Tumors
Medical subject headings
Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TJ107 +PembrolizumabBiological

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

Study groups in NCT05145907
Study groupRoleWhat they receive
TJ107+PembrolizumabExperimentalTJ107 1200ug/Kg,Q12W + Pembrolizumab 200mg Q3W
Receives: Biological: TJ107 +Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of Adverse events

    The rate of Adverse events

    Measured: Through the study assessed up to 2 years

  2. The rate of Senior Adverse Events

    The rate of Senior Adverse Events

    Measured: Through the study assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2021
  2. Study start22 Dec 2021
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, single arm
Masking
None (open label)
Enrolment
133 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05145907
Sponsor's protocol ID
TJ107001STM202
Status last verified
Apr 2024
First submitted
1 Nov 2021
Last updated
15 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TJ107 +Pembrolizumab in people with Triple-negative Breast Cancer and Head and Neck Squamous Cell Carcinoma, run by TJ Biopharma Co., Ltd. at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of Adverse events (time frame: Through the study assessed up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05145907.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.

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