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Advanced CancerPhase 1/2NCT05154630

Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors

A Phase 1/2 study testing TQB2858 injection in people with Advanced Cancer and Advanced Soft-tissue Sarcoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is divided into two phases: dose escalation and cohort expansion. The dose escalation stage aims to evaluate the tolerability, pharmacokinetic characteristics and safety of TQB2858 injection in subjects with advanced malignant tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Cancer, Advanced Soft-tissue Sarcoma
What is being tested?
TQB2858 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
5 sitesChina
Study dates
14 Jan 2022to 30 Jun 2023
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Phase I (dose-escalation phase).
  • Patients with advanced malignant solid/hematologic tumors who have a histologically and/or cytologically confirmed diagnosis and who have failed standard therapy or lack effective therapies.
  • Phase II (cohort expansion phase).
  • Unresectable, recurrent or metastatic adenoid soft tissue sarcoma diagnosed by histology.
  • Previously received anti-vascular targeted drug therapy
  • Have at least one measurable lesion Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
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  • Age: 18 to 70 years old;
  • The Eastern Cooperative Oncology Group (ECOG) score: 0 to 1;
  • The expected survival period is ≥3 months;
  • Normal function of major organs
  • Women of childbearing age should agree to use effective contraceptive measures during the study period and 6 months after the end of the study, and have a negative serum or urine pregnancy test within 7 days before enrollment in the study; men should agree to use effective contraception during the study period and after the end of the study period 6 Effective contraceptive measures must be used within one month.
  • Patients voluntarily enroll in this study, sign an informed consent form and comply well.

Who cannot join

  • Combined diseases and medical history:
  • Have presented with or currently have concurrent other malignancies within 2 years.
  • Unresolved toxic reactions due to any prior treatment above Common Terminology Criteria for Adverse Events(CTCAE) grade 1, excluding alopecia, peripheral sensory nerve disorders.
  • Major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment.
  • Long-term untreated wounds or fractures.
  • An arterial/venous thrombotic event within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism.
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  • Persons with a history of psychotropic substance abuse who are unable to abstain or have a mental disorder.
  • Subjects with any severe and/or uncontrollable disease, including:
  • Tumor-related symptoms and treatment:
  • Have received surgery, chemotherapy, radiotherapy or other anti-cancer therapy within 4 weeks prior to the start of study treatment.
  • Treatment with proprietary Chinese medicines with clear antitumor indications in the National Medical Products Administration (NMPA)-approved drug formulary within 2 weeks prior to the start of study treatment.
  • Prior receipt of immune dual anti-treatment drugs against the same target of TQB2858 injection.
  • Uncontrolled pleural effusions, pericardial effusions, or ascites that still require repeated drainage (in the judgment of the investigator);
  • Brain metastases with less than 4 weeks of stable symptom control after discontinuation of dehydrating agents and steroids.
  • Research and treatment related:
  • History of live attenuated vaccination within 28 days prior to the start of study treatment.
  • Prior history of severe allergy to macromolecular drugs or allergy to known components of TQB2858 injection.
  • Active autoimmune disease requiring systemic therapy that occurred within 2 years prior to the start of study treatment.
  • Diagnosis of immunodeficiency or being treated with systemic glucocorticoids or any other form of immunosuppressive therapy.
  • Participation in other clinical trials of antineoplastic drugs within 4 weeks prior to enrollment.
  • Subjects who, in the judgment of the investigator, have a concomitant illness that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or for whom other reasons are deemed to exist for ineligibility for enrollment.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100144

  • West China Hospital，Sichuan University

    Chengdu, Sichuan, 610000

Other trials in China

About this study

Official title: Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancies

This study is divided into two phases: dose escalation and cohort expansion. The dose escalation stage aims to evaluate the tolerability, pharmacokinetic characteristics and safety of TQB2858 injection in subjects with advanced malignant tumors. The cohort expansion phase aims to evaluate the initial efficacy and safety of TQB2858 injection in patients with soft tissue sarcoma, and to explore treatment-related biomarkers.

Being tested
TQB2858 injection

What participants receive

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

  • TQB2858 injectionDrug

    TQB2858 is a Programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β(TGF-β) double antibody.

Study groups in NCT05154630
Study groupRoleWhat they receive
TQB2858 injectionExperimentalParticipants will receive 3 mg/60 mg/600 mg/1200 mg/1800 mg single dose of TQB2858 injection on Day 1, iv (injection of vein), once every three weeks.
Receives: Drug: TQB2858 injection

What is being measured

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

  1. Maximum tolerated dose (MTD)

    If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.

    Measured: Baseline up to 48 weeks

  2. Overall response rate (ORR)

    ORR refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or iRECIST (CR and PR under iRECIST criteria can occur after imaging disease progression).

    Measured: up to 48 weeks

Secondary outcomes (4)

  1. Disease control rate（DCR）

    DCR refers to the percentage of subjects with CR, PR, or stable disease (SD) of 6 weeks or more as determined by RECIST 1.1 or iRECIST (CR, PR, SD under iRECIST criteria can occur after imaging disease progression).

    Measured: up to 48 weeks

  2. Overall survival (OS)

    OS is defined as the time from enrollment to death from any cause.

    Measured: Baseline up to die

  3. Progression-Free Survival (PFS)

    PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.

    Measured: up to 48 weeks

  4. Duration of Response (DOR)

    DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes.

    Measured: up to 48 weeks

Timeline

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

  1. First posted13 Dec 2021
  2. Study start14 Jan 2022
  3. Primary completion31 Mar 2023
  4. Study completion30 Jun 2023

Why it stopped: The sponsor has decided to terminate this study based on the current clinical research status of dual antibody drugs and full communication with the investigators.

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05154630
Sponsor's protocol ID
TQB2858-I-05
Status last verified
Dec 2023
First submitted
9 Dec 2021
Last updated
18 Jan 2024
Results posted
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 TQB2858 injection in people with Advanced Cancer and Advanced Soft-tissue Sarcoma, 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 12 inclusion and 21 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: stopped early, as of the sponsor's last update on 18 Jan 2024. 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?

The study was stopped early (reason given: The sponsor has decided to terminate this study based on the current clinical research status of dual antibody drugs and full communication with the investigators.). 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?

Maximum tolerated dose (MTD) (time frame: Baseline up to 48 weeks). 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 NCT05154630.

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 18 Jan 2024.

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