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Advanced Solid TumorPhase 1/2NCT05645315

Clinical Trial of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors

A Phase 1/2 study testing TQB2618 injection and TQB2450 injection in people with Advanced Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This project is a phase Ib clinical trial study evaluating the efficacy and safety of TQB2618 injection combined with TQB2450 injection in patients with advanced solid tumors, the trial plan to enroll 127 subjects, the trial design is a phase I.b dose exploration and cohort expansion clinical study, aiming to evaluate… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
TQB2618 injection and TQB2450 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
5 sitesChina
Study dates
28 Apr 2022to Jun 2024
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects voluntarily participated the study and signed the informed consent form;
  • Age: 18~75 years old (when signing the informed consent form); ECOG PS score: 0~1 points; Expected survival is more than 3 months;
  • The enrolled patients meet the following criteria:
  • Satge I (dose exploration): patients with advanced malignant solid tumors confirmed by tissue and/or cytology, where standard therapy has failed or there is a lack of effective treatment;
  • Stage 2 (cohort Expansion):
  • Cohort 1: PD-L1-positive patients with advanced first-line NSCLC;
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  • Cohort 2: PD-L1 positive patients with advanced immunoresistant NSCLC;
  • Patients with locally advanced (stage III.B/III.C), recurrent or metastatic (stage IV) NSCLC who are not histologically or cytologically confirmed and are not suitable for radical concurrent chemoradiotherapy.
  • For non-squamous non-small cell lung cancer, the test proves the absence of EGFR mutation, ALK fusion, ROS1 mutation (for squamous non-small cell lung cancer, patients with known mutations in the above genes are excluded, and testing is not mandatory for those whose status is unknown);
  • Positive PD-L1 expression ratio≥1% [TC (tumor cells) or IC (immune cells) ≥1%];
  • Cohort 1 advanced first-line patients: no systemic antitumor therapy for advanced disease.
  • Patients with advanced immunoresistance in cohort 2: at least prior failure of platinum-containing chemotherapy and immune checkpoint inhibitor (PD-1 or PD-L1) therapy (combined or sequential therapy allowed)
  • at least one measurable lesion confirmed according to RECIST 1.1;
  • The main organs function normally
  • Female subjects of childbearing age should agree that contraception must be used during the study and for 6 months after the end of the study

Who cannot join

  • Comorbidities and medical history:
  • Have received chemotherapy within 3 weeks before the first dose, radiotherapy (except palliative radiotherapy for non-target lesions) or other antineoplastic drugs within 2 weeks before the first dose (the washout period is calculated from the end of the last treatment);
  • Have developed or are currently suffering from other malignant tumors within 3 years before the first dose. The following two conditions can be enrolled: other malignancies treated with a single surgery, achieving 5 consecutive years of disease-free survival (DFS); cured carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor-invasive basement membrane)];
  • unresolved toxicities above CTC AE grade 1 due to any prior treatment, excluding hair loss;
  • Major surgical treatment and obvious traumatic injury within 28 days before the first dose;
  • Wounds or fractures that have not healed for a long time;
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  • Arterioven/venous thrombotic events within 6 months prior to the first dose;
  • Those with a history of psychotropic substance abuse and cannot quit or have mental disorders;
  • Subjects with any severe and/or uncontrolled disease.
  • Tumor-related symptoms and treatment:
  • Received proprietary Chinese medicine treatment with anti-tumor indications specified in the NMPA-approved drug instructions within 2 weeks before the first dose;
  • Have received previous anti-TIM-3 antibody treatment;
  • Have received previous immunotherapy drugs such as anti-PD-1/PD-L1 antibody and anti-CTLA-4 antibody (only applicable to cohort 1 of the Stage II cohort expansion study: advanced first-line NSCLC patients with positive PD-L1 expression);
  • uncontrolled pleural effusion, pericardial effusion, or ascites that still requires repeated drainage (judged by the investigator);
  • Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases or symptom control for less than 2 weeks;
  • Study treatment-related:
  • History of live attenuated vaccination within 28 days before the first dose or planned live attenuated vaccination during the study period;
  • Those who have severe hypersensitivity reactions after using macromolecular drugs;
  • Active autoimmune disease requiring systemic therapy within 2 years before the first dose (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants); asthma patients requiring bronchodilators for medical intervention.
  • Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first dose;

Trial locations and contacts

5 sites in 1 country.

Lin Wu, Doctor contact

+86 13170419973

wulin-calf@vip.163.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410005

    Lin Wu, Doctor, +8613170419973, wulin-calf@vip.163.com

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Yong-sheng Wang, Doctor, 18980602258, wangys@wchscu.cn

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Gen Lin, Doctor, 13313786157, fjzlllg133@fjzlhospital.com

    Not yet recruiting

  • Tongji Hospital,Tongji Medical College of HUST

    Wuhan, Hubei, 430030

    Qian Chu, Doctor, 13212760715

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Xing Ya Li, Doctor, +86 13838253946, lixingyavip@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors

This project is a phase Ib clinical trial study evaluating the efficacy and safety of TQB2618 injection combined with TQB2450 injection in patients with advanced solid tumors, the trial plan to enroll 127 subjects, the trial design is a phase I.b dose exploration and cohort expansion clinical study, aiming to evaluate the safety and efficacy of TQB2618 injection combined with TQB2450 injection in patients with advanced malignant solid tumors, and to evaluate TQB2618 injection, Pharmacokinetic characteristics, receptor occupancy and immunogenicity characteristics of TQB2450 injection; Biomarker studies related to the mechanism of action, safety and/or pathological mechanism of efficacy have dose-limiting toxicity (DLT) in Phase I, recommended dose in Phase II (RP2D), and objective response rate (ORR) in Phase II as the primary endpoints.

Being tested
TQB2618 injection and TQB2450 injection

What participants receive

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

  • TQB2618 injection and TQB2450 injectionDrug

    TQB2618 is a TIM-3 receptor monoclonal antibody; TQB2450 is a new sequence of innovative anti-PD-L1 fully humanized monoclonal antibody;

Study groups in NCT05645315
Study groupRoleWhat they receive
TQB2618 injection+TQB2450 injectionExperimentalTQB2618 injection combined with TQB2450 injection, 21 days as a treatment cycle.
Receives: Drug: TQB2618 injection and TQB2450 injection

What is being measured

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

  1. Dose-limiting toxicity

    The occurrence of severe toxicities during the first cycle of anti-cancer therapy

    Measured: within the first treatment cycle for 21 days

  2. Phase II recommended dose

    Dose selection in the expansion phase

    Measured: Through phase 1 completion, an average of half a year

  3. Objective response rate

    ORR is defined as the percentage of participants with progressive disease (PD) from first dose to first recorded or death from any cause of complete remission (CR) and partial remission (PR) based on investigator records

    Measured: Up to 12 months

Secondary outcomes (8)

  1. Progression-free survival

    PFS is defined as the time from randomization to the first recorded progressive disease (PD) or death from any cause.

    Measured: Up to 12 months

  2. Disease control rate

    The time when participants first achieved full or partial remission of disease progression.

    Measured: Up to 12 months

  3. Duration of remission

    The time from the start of the first evaluation of the tumor as Complete Response or Partial Response to the first assessment as Progressive Disease or death from any cause.

    Measured: Up to 12 months

  4. Overall survival

    OS is defined as the time from randomization to death from any cause. Participants who did not die at the end of the extended follow-up period, or who lost follow-up during the study, were reviewed on the last date known to be alive.

    Measured: Up to 18 months

  5. Maximum plasma drug concentration

    Maximum plasma drug concentration ia a pharmacokinetic parameter

    Measured: 1 hour before and 30 minutes after TQB2450 injection administration; 30 minutes, 4, 8, 24, 48, 144, 312 hours after TQB2618 injection administration of cycle 1; 30 minutes after TQB2618 injection administration of cycle 2-8. Each cycle is 21 days.

  6. Immunogenicity

    Immunogenicity is evaluated by the detection of anti-drug antibodies (ADA) after administration

    Measured: Each cycle is 21 days. 1 hour before administration of cycles 1, 2, 4, and 8, 1 hour before administration at the start of every 6 cycles thereafter; 30 and 90 days after the last dose.

  7. Free Tim3 receptors on the surface of CD3+ T cells

    TIM-3 receptor mass (RO) of TQB2618 on human immune cell membranes

    Measured: before and 30 minutes after the end of administration of per cycle during cycles 1-8; when patients withdrawn from the group due to Progression Disease

  8. Adverse events (AEs)

    Occurrence rate of all adverse events

    Measured: Up to 28 days after last dose or the initiation of a new antineoplastic therapy, whichever comes first

Timeline

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

  1. First posted9 Dec 2022
  2. Study start28 Apr 2022
  3. Primary completionDec 2023 (estimated)
  4. Study completionJun 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
127 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05645315
Sponsor's protocol ID
TQB2618-TQB2450-Ib-01
Status last verified
Nov 2022
First submitted
21 Nov 2022
Last updated
9 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQB2618 injection and TQB2450 injection in people with Advanced Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 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 15 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 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Lin Wu, Doctor (+86 13170419973, wulin-calf@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (time frame: within the first treatment cycle for 21 days). The study lists 3 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 NCT05645315.

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 9 Dec 2022.

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