Advanced High-grade SarcomaPhase 2NCT05262101
Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma
A Phase 2 study testing TQB2858 injection in people with Advanced High-grade Sarcoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a single-arm, open-label, multicenter Phase Ib clinical trial evaluating TQB2858 injection in the treatment of advanced high-grade sarcoma. To evaluate the preliminary efficacy and safety of TQB2858 injection in patients with advanced high-grade sarcoma, and to explore the relevant biomarkers of TQB2858… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced High-grade 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
- 7 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2022to 30 Nov 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Histologically confirmed unresectable, recurrent or metastatic high-grade sarcoma;
- 2 Received at least first-line therapy before, disease progression or intolerance during treatment, or disease progression after treatment; (excluding alveolar soft tissue sarcoma and clear cell sarcoma)
- Cohort 1: newly treated acinar soft tissue sarcoma;
- Cohort 2: Acinar soft tissue sarcoma with failed PD-1 therapy;
- Cohort 3: Other subtypes (pleomorphic sarcoma, classic osteosarcoma, Ewing sarcoma, chondrosarcoma, dedifferentiated liposarcoma, etc.).
- 3 Age: 18 to 70 years old;
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- 4 The Eastern Cooperative Oncology Group (ECOG) score: 0 to 1;
- 5 The expected survival period is ≥3 months;
- 6 Normal function of major organs
- 7 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.
- 8 Patients voluntarily enroll in this study, sign an informed consent form and comply well.
Who cannot join
- 1 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:
- 2 Tumor-related symptoms and treatment:
- Received surgery, chemotherapy, radiotherapy, or other anticancer 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.
- Uncontrolled pleural effusions, pericardial effusions, or ascites that still require repeated drainage;
- Brain metastases with less than 4 weeks of stable symptom control after discontinuation of dehydrating agents and steroids.
- 3 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.
- 4 Participation in other clinical trials of antineoplastic drugs within 4 weeks prior to enrollment.
- 5 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
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Single-arm, Open-label, Multicenter Phase Ib Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma
This study is a single-arm, open-label, multicenter Phase Ib clinical trial evaluating TQB2858 injection in the treatment of advanced high-grade sarcoma. To evaluate the preliminary efficacy and safety of TQB2858 injection in patients with advanced high-grade sarcoma, and to explore the relevant biomarkers of TQB2858 injection.
- Conditions
- Advanced High-grade Sarcoma
- 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 dual-function fusion protein that is aProgrammed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β(TGF-β) double antibody.
| Study group | Role | What they receive |
|---|---|---|
| TQB2858 injection | Experimental | TQB2858 injection (1800mg intravenous(iv), on day 1 of every 3 weeks) Receives: Drug: TQB2858 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Objective response rate 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 modified RECIST1.1 for immune based therapeutics (iRECIST) (CR and PR under iRECIST criteria can occur after imaging disease progression).
Measured: up to 48 weeks
Secondary outcomes (4)
Disease control rate (DCR)
Disease control rate 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
Overall survival (OS)
Overall survival defined as the time from enrollment to death from any cause.
Measured: Baseline up to die
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
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.
- First posted2 Mar 2022
- Study start9 May 2022
- Primary completion28 Jun 2023
- Study completion30 Nov 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced High-grade SarcomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262101
- Sponsor's protocol ID
- TQB2858-Ib-02
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Open-label, Multicenter Phase Ib Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma
- ClinicalTrials.gov ID
- NCT05262101
- Acronym / sponsor ID
- TQB2858-Ib-02
- Conditions
- Advanced High-grade Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, open-label, multicenter Phase Ib clinical trial evaluating TQB2858 injection in the treatment of advanced high-grade sarcoma. To evaluate the preliminary efficacy and safety of TQB2858 injection in patients with advanced high-grade sarcoma, and to explore the relevant biomarkers of TQB2858 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2858 injection | Experimental | Drug: TQB2858 injectionTQB2858 injection (1800mg intravenous(iv), on day 1 of every 3 weeks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1 Histologically confirmed unresectable, recurrent or metastatic high-grade sarcoma;
- 2 Received at least first-line therapy before, disease progression or intolerance during treatment, or disease progression after treatment; (excluding alveolar soft tissue sarcoma and clear cell sarcoma)
- 3 Age: 18 to 70 years old;
- 4 The Eastern Cooperative Oncology Group (ECOG) score: 0 to 1;
- 5 The expected survival period is ≥3 months;
Key exclusion criteria (20 listed)
- 1 Combined diseases and medical history:
- 2 Tumor-related symptoms and treatment:
- 3 Research and treatment related:
- 4 Participation in other clinical trials of antineoplastic drugs within 4 weeks prior to enrollment.
- 5 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2858 injectionTQB2858 is a dual-function fusion protein that is aProgrammed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β(TGF-β) double antibody. | Drug | TQB2858 injection |
Primary outcome
Overall response rate (ORR)
Time frame: up to 48 weeks
Objective response rate 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 modified RECIST1.1 for immune based therapeutics (iRECIST) (CR and PR under iRECIST criteria can occur after imaging disease progression).
4 secondary outcomes
Disease control rate (DCR)
Time frame: up to 48 weeks
Overall survival (OS)
Time frame: Baseline up to die
Progression-Free Survival (PFS)
Time frame: up to 48 weeks
Duration of Response (DOR)
Time frame: up to 48 weeks
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB2858 injection in people with Advanced High-grade Sarcoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site 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 11 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: stopped early, as of the sponsor's last update on 22 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 1 site 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?
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?
Overall response rate (ORR) (time frame: up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2024.