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OsteosarcomaPhase 1NCT06438783

TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid Tumors

A Phase 1 study testing 1200mg of TQB2928 injection+Anlotinib and 1800mg of TQB2928 injection+Anlotinib in people with Osteosarcoma and Other Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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 is a multicenter, open-label, multi-cohort Phase Ib trial to evaluate the efficacy and safety of TQB2928 injection combined with anlotinib hydrochloride capsule in patients with relapsed/metastatic osteosarcoma and other relapsed/metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Osteosarcoma, Other Solid Tumors
What is being tested?
1200mg of TQB2928 injection+Anlotinib and 1800mg of TQB2928 injection+Anlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesChina
Study dates
15 Feb 2024to 18 Jun 2025
Phase
Phase 1
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

  • Pathological diagnosis of high-grade osteosarcoma(cohort I),dedifferentiated liposarcoma or polytypic liposarcoma(cohort II),unsuitable for local treatment;
  • The requirements for front-line treatment received by subjects are as follows:
  • Subjects with osteosarcoma have failed at least first-line chemotherapy and are not suitable for re-receiving first-line chemotherapy ,or progression within 6 months of the end of first-line therapy;
  • Subjects with dedifferentiated liposarcoma or polytype liposarcoma who have received at least first-line chemotherapy failure for recurrent/metastatic sites or relapse during postoperative adjuvant chemotherapy or within 6 months after treatment(considered first-line treatment failure).

Who cannot join

  • History of hemolytic anemia from any cause (including Evans syndrome) within 3 months prior to first dosing;
  • Subjects with osteosarcoma or dedifferentiated liposarcoma/polytype liposarcoma who have previously used antiangiogenic tyrosine kinase inhibitors (TKI) or bevacizumab or its biosimilar, such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib;
  • Previous antibody or fusion protein or small molecule drug targeting CD47 or Signal-regulatory protein α (SIRRP-α).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Beijing jishuitan hospital

    Beijing, Beijing Municipality, 100035

  • Pekjing university people's hospital

    Beijing, Beijing Municipality, 100044

  • Beijing cancer hospital

    Beijing, Beijing Municipality, 100142

  • Hunan cancer hospital

    Changsha, Hunan, 410031

  • Tianjin medical university cancer institute&hospital

    Tianjin, Tianjin Municipality, 300181

Other trials in China

About this study

Official title: A Multicenter, Open-label, Multi-cohort Phase Ib Trial Evaluating the Efficacy and Safety of TQB2928 Injection Combined With Anlotinib Hydrochloride Capsule in Relapsed/Metastatic Osteosarcoma and Other Relapsed/Metastatic Solid Tumors

This is a multicenter, open-label, multi-cohort Phase Ib trial to evaluate the efficacy and safety of TQB2928 injection combined with anlotinib hydrochloride capsule in patients with relapsed/metastatic osteosarcoma and other relapsed/metastatic solid tumors.

Being tested
1200mg of TQB2928 injection+Anlotinib, 1800mg of TQB2928 injection+Anlotinib
Medical subject headings
Osteosarcoma

What participants receive

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

  • 1200mg of TQB2928 injection+AnlotinibDrug

    TQB2928 is a novel humanized immunoglobulin G4 (IgG4) subtype monoclonal antibody targeting Cluster of Differentiation 47 (CD47).

  • 1800mg of TQB2928 injection+AnlotinibDrug

    TQB2928 is a novel humanized igG4 subtype monoclonal antibody targeting CD47.

Study groups in NCT06438783
Study groupRoleWhat they receive
1200mg of TQB2928 injection +AnlotinibExperimental21 days as a treatment cycle.
Receives: Drug: 1200mg of TQB2928 injection+Anlotinib
1800mg of TQB2928 injection+AnlotinibExperimental21 days as a treatment cycle.
Receives: Drug: 1800mg of TQB2928 injection+Anlotinib

What is being measured

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

  1. Cohort 1: Progression-Free Survival (PFS) of 6 months

    Cohort 1: Kaplan-Meier method was used to plot the survival curve, in which the cumulative survival rate and 95% confidence interval corresponding to the progression-free survival time of 6 months were obtained.

    Measured: Up to 6 months

  2. Cohort 2: Overall response rate (ORR)

    Cohort 2: The percentage of subjects with complete (CR) or partial response (PR) as determined by the investigator according to the RECIST 1.1 criteria.

    Measured: Up to 6 months

Secondary outcomes (9)

  1. Cohort 1: Progression-Free Survival (PFS) of 4 months

    Cohort 1: Survival curve was plotted using Kaplan-Meier method. In the curve, the corresponding cumulative survival rate and 95% confidence interval for progression-free survival of 4 months were obtained.

    Measured: Up to 4 months

  2. Cohort 1: Overall response rate (ORR)

    Cohort 1: The percentage of subjects with complete (CR) or partial response (PR) as determined by the investigator according to the RECIST 1.1 criteria.

    Measured: Baseline up to 96 weeks

  3. Cohort 2: Progression-Free Survival (PFS) of 6 months

    Cohort 2: Kaplan-Meier method was used to plot the survival curve with the corresponding cumulative survival rate and 95% confidence interval (95% CI) when the progression-free survival time was 6 months. The overall population and 2 dose groups were counted separately (including participants in the safe introduction period and the extended period).

    Measured: Up to 6 months

  4. Progression-Free Survival (PFS) of Cohort 1 and Cohort 2

    The time between medication or random initiation and objective progression of disease or death from any cause, whichever comes first.

    Measured: Up to 96 weeks

  5. Disease control rate (DCR) of Cohort 1 and Cohort 2

    The percentage of subjects with complete response (CR), partial response (PR), or stable disease (SD) for 6 weeks or more as determined by the investigator based on RECIST 1.1.

    Measured: Up to 6 weeks

  6. Duration of response(DOR) of Cohort 1 and Cohort 2

    For subjects whose optimal response was complete response (CR) or partial response (PR), defined as from the date when tumor response was first documented to the date when disease progression was first documented or the date of death from any cause, whichever came first.

    Measured: Baseline up to 96 weeks

  7. Overall survival (OS) of Cohort 1 and Cohort 2

    From randomization to the time of death from any cause.

    Measured: Baseline up to 96 weeks

  8. Adverse event rate of Cohort 1 and Cohort 2

    Incidence and severity of adverse events (AES) and serious adverse events (SAEs), abnormal laboratory test indicators and treatment-related adverse events (TEAEs).

    Measured: Baseline up to 96 weeks

  9. Incidence of Anti-drug antibody (ADA )and Neutralizing Antibody( NAb )

    The positive rates of immunogenicity (ADA and NAb) in subjects were summarized and descriptive statistical analysis was performed.

    Measured: 30 minutes before administration on day 1 of cycles 1, 2, 4 and 8 (each cycle is 21 days), day 90 after the last administration (±7 days)

Timeline

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

  1. First posted3 Jun 2024
  2. Study start15 Feb 2024
  3. Primary completion18 Jun 2025
  4. Study completion18 Jun 2025

Why it stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06438783
Sponsor's protocol ID
TQB2928-ALTN-Ib-01
Status last verified
Dec 2025
First submitted
27 May 2024
Last updated
12 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 1200mg of TQB2928 injection+Anlotinib and 1800mg of TQB2928 injection+Anlotinib in people with Osteosarcoma and Other Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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 4 inclusion and 3 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 12 Dec 2025. 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 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.

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: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.). 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?

Cohort 1: Progression-Free Survival (PFS) of 6 months (time frame: Up to 6 months). 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 NCT06438783.

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 12 Dec 2025.

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