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Soft Tissue SarcomaPhase 2NCT05656144

Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma

A Phase 2 study testing Cadonilimab in people with Soft Tissue Sarcoma, run by Peking University Cancer Hospital & Institute.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study was to evaluate the efficacy and safety of Cadonilimab monotherapy in the treatment of patients with advanced soft tissue sarcoma who have received at least one chemotherapy (including anthracyclines) for advanced diseases (excluding alveolar soft part sarcoma). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Cadonilimab
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
No sites listed yet
Study dates
Feb 2023to Jun 2025
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. Written and signed informed consent.
  • 2. Male or female, age≥ 18 and ≤ 70 years old on day of signing informed consent.
  • 3. Pathologically confirmed unresectable or metastatic soft tissue sarcoma, mainly including Undifferentiated pleomorphic sarcoma/malignant fiber histiocytoma, Alveolar soft part sarcoma, dedifferentiated liposarcoma, fibrosarcoma, Leiomyosarcoma, Anigosarcoma, Synovial sarcoma.
  • 4. Patients who have failed at least one chemotherapy (including anthracyclines) in the last 6 months (excluding acinar soft tissue sarcoma).

Who cannot join

  • 1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
  • 2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
  • 3. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).
  • 4. Active autoimmune diseases;
  • 5. History of transplantation;
  • 6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).

About this study

Official title: A Single-arm, Single-center, Open-label, Phase II Study Assessing Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma

The purpose of this study was to evaluate the efficacy and safety of Cadonilimab monotherapy in the treatment of patients with advanced soft tissue sarcoma who have received at least one chemotherapy (including anthracyclines) for advanced diseases (excluding alveolar soft part sarcoma).

Read the detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period (≤28 days) to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be treated with Cadonilimab monotherapy.

Being tested
Cadonilimab
Medical subject headings
Sarcoma

What participants receive

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

  • CadonilimabDevice

    AK104, 6mg/kg, Q2W

Study groups in NCT05656144
Study groupRoleWhat they receive
CadonilimabExperimentalCadonilimab monotherapy
Receives: Device: Cadonilimab

What is being measured

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

  1. Anti-tumor activity of Cadonilimab using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

    Measured: up to 2 years

Secondary outcomes (6)

  1. Disease control rate (DCR)

    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

    Measured: up to 2 years

  2. Duration of response (DoR)

    Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: up to 2 years

  3. Time to recurrence (TTR)

    TTR is defined as the time to response base on RECIST v1.1

    Measured: up to 2 years

  4. Progression-free survival (PFS)

    PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first)

    Measured: up to 2 years

  5. Overall survival (OS)

    Overall survival is defined as the time from the start of treatment with Cadonilimab until death due to any cause.

    Measured: up to 2 years

  6. AE

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

    Measured: From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first

Timeline

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

  1. First posted19 Dec 2022
  2. Study startFeb 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionJun 2025 (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
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05656144
Sponsor's protocol ID
AK104-IIT-006
Status last verified
Dec 2022
First submitted
9 Dec 2022
Last updated
19 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab in people with Soft Tissue Sarcoma, run by Peking University Cancer Hospital & Institute.

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 6 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 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Anti-tumor activity of Cadonilimab using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator (time frame: up to 2 years). 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 NCT05656144.

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 19 Dec 2022.

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