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Triple Negative Breast CancerPhase 2NCT06202313

Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer

A Phase 2 study testing Cadonilimab and Eribulin in people with Triple Negative Breast Cancer, run by Shengjing Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) plus Eribulin compared to the efficacy and safety of Eribulin monotherapy in the treatment of adult patients with recurrent, or metastatic triple negative breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Cadonilimab and Eribulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteChina
Study dates
10 Feb 2024to 30 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to understand and voluntarily sign a written informed consent form, which must be signed before the designated research procedures required for the study are carried out.
  • Age at the time of signing the Informed Consent Form (ICF) is ≥ 18 years old and ≤ 75 years old, both male and female.
  • The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
  • The expected survival period is ≥ 3 months.
  • Recurrent or metastatic incurable triple negative breast cancer confirmed by histology and/or cytology.
  • Having received ≤ 2-line systematic treatment for recurrent or metastatic diseases, including: ① untreated after recurrence or metastasis, but receiving paclitaxel and anthracycline drugs within 12 months before recurrence or metastasis (including neoadjuvant treatment stage and adjuvant treatment stage), Or ② After recurrence or metastasis, the subject has received 1-2 lines of treatment (including at least one anthracycline and one paclitaxel in the previous adjuvant treatment stage, neoadjuvant treatment stage, or treatment after recurrence/metastasis).
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  • According to the RECIST v1.1 standard, there is at least one measurable tumor lesion. Agree to provide archived or freshly obtained tumor tissue samples (formalin fixed paraffin embedded [FFPE] tissue wax blocks or at least 5 unstained tumor tissue slice samples) to confirm PD-L1 expression.
  • The time interval between the last treatment: (a) If the last treatment is targeted therapy such as Olaparib, the interval should be ≥ 2 weeks; (b) If the last treatment is chemotherapy, an interval of ≥ 4 weeks is required.
  • Having good organ function:
  • Blood routine examination (no blood components or cell growth factors were used to support treatment within the first 2 weeks of randomization):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
  • Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9.0g/dL.
  • Kidney:
  • Creatinine < 1.5 × ULN, or creatinine clearance rate (CrCl) calculated value ≥ 50mL/min;
  • The Cockcroft Fault formula will be used to calculate CrCl: CrCL (mL/min)={(140 age) × Body weight (kg) × F} /(SCr (mg/dL) × 72) Among them: F=1 for males and F=0.85 for females; SCr=serum creatinine. Urinary protein<2+or 24-hour urine protein quantification<1.0g.
  • Liver:
  • Serum total bilirubin (TBiL) ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN (AST and ALT ≤ 5 for subjects with liver metastasis) × ULN, but not accompanied by elevated bilirubin); Serum albumin (ALB) ≥ 28g/L.
  • Coagulation function:
  • International standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
  • Female subjects with fertility must undergo a serum pregnancy test within 72 hours before the first medication, and the result should be negative. If a female subject with fertility engages in sexual activity with an unsterilized male partner, the subject must adopt an acceptable contraceptive method starting from screening and must agree to continue using the contraceptive method for 120 days after the last dose of the study drug; Periodic abstinence and safe period contraception are unacceptable contraceptive methods. Whether to stop contraception after this time point should be discussed with researchers.
  • Women with fertility refer to those who have not undergone surgical sterilization (i.e. bilateral fallopian tube ligation, bilateral oophorectomy, or total hysterectomy) or those who have not undergone menopause (defined as those who have ceased menstruation for at least 12 consecutive months without alternative medical reasons, and whose serum follicle stimulating hormone levels are within the laboratory reference range of postmenopausal women);
  • An efficient contraceptive method refers to a contraceptive method with a low failure rate (such as less than 1% per year) under continuous and correct use. Not all contraceptive methods are efficient. In addition to barrier contraception, female subjects with fertility can also use hormonal contraception (such as birth control pills), intrauterine device contraception, etc. to ensure that pregnancy does not occur.

Who cannot join

  • human epidermal growth factor receptor 2 (HER2) is positive and/or hormone receptor is positive.
  • Previously received treatment with PD-1 monoclonal antibody, PD-L1 monoclonal antibody, or CTLA-4 monoclonal antibody.
  • Received systematic anti-tumor therapy within the first 4 weeks of randomization, including chemotherapy, radiation therapy, immunotherapy, targeted therapy (small molecule targeted therapy within the first 2 weeks of randomization), biological agent therapy, etc; Palliative local treatment within the first 2 weeks of randomization; Received systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within the first 2 weeks of randomization; In the first 2 weeks of randomization, they received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications.
  • Currently participating in another clinical study, unless it is an observational, non-interventional clinical study, or a follow-up period of an intervention study.
  • Have active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal diseases. However, participants who meet the following requirements and have measurable lesions outside the central nervous system are allowed to be enrolled: asymptomatic after treatment, imageologically stable for at least 4 weeks before the start of study treatment (if there are no new or expanded brain metastases), and have stopped systemic glucocorticoid and anticonvulsant drug treatment for at least 2 weeks.
  • Have clinical symptoms of pleural effusion, pericardial effusion, or pleural/ascites that require frequent drainage (≥ once per month).
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  • Active autoimmune diseases that require systematic treatment within the first 2 years of randomization, or autoimmune diseases that the researcher determines may recur or plan treatment. Except for the following:
  • Skin diseases that do not require systematic treatment (such as vitiligo, alopecia, psoriasis, or eczema);
  • Hypothyroidism caused by autoimmune thyroiditis requires only stable doses of hormone replacement therapy;
  • Type I diabetes requiring only a stable dose of insulin replacement therapy;
  • Childhood asthma has completely relieved, and no intervention is required in adulthood;
  • Researchers have determined that the disease will not recur without external triggering factors.
  • Any of the following cardiovascular or cerebrovascular diseases or risk factors:
  • Myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (grade 2 or above according to the New York Heart Association functional classification), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolism event occurred within the first 6 months of randomization.
  • A history of deep vein thrombosis, pulmonary embolism, or other severe thromboembolism within the first 3 months of randomization.
  • Have major vascular diseases such as aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis that may endanger life or require surgery within 6 months.
  • Previous history of myocarditis and cardiomyopathy.
  • Left ventricular ejection fraction (LVEF)<50%.
  • Toxicity that has not been alleviated by previous anti-tumor therapy is defined as failure to regress to the National Cancer Institute Adverse Event General Terminology Standard (NCICTCAE v5.0) level 0 or 1, or the level specified in the inclusion/exclusion criteria, except for hair loss/pigmentation. Subjects who have experienced ≥ 3 levels of immune related toxicity during previous treatment with immune checkpoint inhibitors are not allowed to be enrolled.
  • For subjects who experience irreversible toxicity and are expected to not worsen after administration of the study drug (such as hearing loss), they may be included in the study after consultation with the medical supervisor. It is known that there are active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal diseases. However, participants who meet the following requirements and have measurable lesions outside the central nervous system are allowed to be enrolled: asymptomatic after treatment, imageologically stable for at least 4 weeks before the start of study treatment (if there are no new or expanded brain metastases), and have stopped systemic glucocorticoid and anticonvulsant drug treatment for at least 2 weeks. Subjects with long-term toxicity that cannot be restored according to the judgment of the researchers may be included in the study after consultation with medical inspectors.
  • According to the NCICTCAE v5.0 standard, it is defined as ≥ Level 2 peripheral nerve disease.
  • The presence of interstitial lung disease or non infectious pneumonia is known, and the disease is currently symptomatic or requires systemic glucocorticoid treatment in the past. Researchers have determined that it may affect the toxicity assessment or management related to the study treatment.
  • Active pulmonary tuberculosis is known to exist. Subjects suspected of active pulmonary tuberculosis need to undergo chest X-ray examination, sputum examination, and elimination through clinical symptoms and signs.
  • Received systemic anti infective therapy (excluding antiviral therapy for hepatitis B or C) within the first 2 weeks of randomization.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Have clinical active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction.
  • Clinically significant bleeding symptoms or clear bleeding tendencies within the first month of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis.
  • For untreated active hepatitis B subjects (HBsAg positive and HBV-DNA more than 1000 copies/ml [200IU/ml] or higher than the lower detection limit), patients with hepatitis B are required to receive anti hepatitis B virus treatment during the study treatment period; Active hepatitis C subjects (with positive HCV antibodies and HCV-RNA levels above the detection limit).
  • Individuals with a known history of immune deficiency or HIV testing positive.
  • Known active syphilis infection.
  • Subjects who require systemic treatment with glucocorticoids (>10mg/day prednisone or equivalent dose) or other immunosuppressive drugs within the first 14 days of randomization. Except for the following:
  • If there is no active autoimmune disease, it is allowed to use inhaled, ophthalmic, or topical corticosteroids or other corticosteroids with a dose ≤ 10mg/day of prednisone or equivalent.
  • The dosage of systemic glucocorticoids in physiological doses is ≤ 10mg/day of prednisone or equivalent doses of other glucocorticoids.
  • Glucocorticoids are used as pretreatment for infusion related reactions or allergic reactions (such as medication before CT examination).
  • Received live vaccine within 30 days prior to randomization, or planned to receive live vaccine during the study period.
  • A history of severe hypersensitivity to other monoclonal antibodies is known.
  • Subjects who have a known history of allergic or hypersensitive reactions to cardunizumab, iribrin, or any of their components.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nan Niu contact

+8618940256668

niunannancy@163.com

China1 site

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Nan Niu, Phd, +8618940256668, niunannancy@163.com

Other trials in China

About this study

Official title: A Multicenter, Randomized, Controlled, Open Label Clinical Study on the Treatment of Recurrent or Metastatic Triple Negative Breast Cancer With Cadonilimab Combined With Eribulin Versus Eribulin Alone

The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) plus Eribulin compared to the efficacy and safety of Eribulin monotherapy in the treatment of adult patients with recurrent, or metastatic triple negative breast cancer.

The primary study hypothes is that the combination of Cadonilimab (AK104) plus Eribulin is superior to Eribulin monotherapy with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator.

Being tested
Cadonilimab, Eribulin
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • CadonilimabBiological

    Also called AK104

    Participants receive Cadonilimab 10mg/kg IV on Day 1 of each 21-day cycle PLUS Eribulin 1.4mg/m^2 IV on Days 1 and 8 of each 21-day cycle.

  • EribulinDrug

    Participants receive Eribulin 1.4mg/m^2 IV on Days 1 and 8 of each 21-day cycle.

Study groups in NCT06202313
Study groupRoleWhat they receive
Cadonilimab + EribulinExperimentalParticipants receive Cadonilimab 10mg/kg IV on Day 1 of each 21-day cycle PLUS Eribulin 1.4mg/m^2 IV on Days 1 and 8 of each 21-day cycle.
Receives: Biological: Cadonilimab; Drug: Eribulin
EribulinActive comparatorParticipants receive Eribulin 1.4mg/m^2 IV on Days 1 and 8 of each 21-day cycle.
Receives: Drug: Eribulin

What is being measured

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

  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator will be presented.

    Measured: Up to approximately 1 year

Secondary outcomes (6)

  1. Overall Survival (OS)

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

    Measured: Up to approximately 2 years

  2. Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator

    ORR is defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters).

    Measured: Up to approximately 1 year

  3. Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator

    For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator will be presented.

    Measured: Up to approximately 1 year

  4. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.

    Measured: From randomization through 30 days after last dose of study treatment

  5. Number of Participants Who Experience a Serious AE (SAE)

    An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; h.) Is a new cancer (that is not a condition of the study) or i.) Is associated with an overdose. The number of participants who experience an SAE will be presented.

    Measured: From randomization through 90 days after last dose of study treatment

  6. Number of Participants Who Experience an Immune-related AE (irAE)

    AEs associated with Cadonilimab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of Cadonilimab treatment and may affect more than one body system simultaneously. For this study irAEs include, but are not limited to:

    Pneumonitis; Diarrhea/Colitis; Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin; Type 1 diabetes mellitus or Hyperglycemia; Hypophysitis; Hyperthyroidism; Hypothyroidism; Nephritis and Renal dysfunction; and Myocarditis. The number of participants who experience an irAE will be presented.

    Measured: From randomization through 90 days after last dose of study treatment for serious irAEs

Timeline

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

  1. First posted11 Jan 2024
  2. Study start10 Feb 2024 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2028 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06202313
Sponsor's protocol ID
AK104-IIT-007
Status last verified
Jan 2024
First submitted
1 Jan 2024
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab and Eribulin in people with Triple Negative Breast Cancer, run by Shengjing Hospital 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 22 inclusion and 37 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: opening soon, as of the sponsor's last update on 11 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nan Niu (+8618940256668, niunannancy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator (time frame: Up to approximately 1 year). 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 NCT06202313.

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 11 Jan 2024.

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