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Endometrial CancerPhase 2NCT05824481

Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer

A Phase 2 study testing Cadonilimab and Lenvatinib in people with Endometrial Cancer and Endometrial Adenocarcinoma, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, multi-center Phase II study of cadonilimab (AK104) combined with lenvatinib in patients with advanced endometrial cancer. The primary objective is to evaluate objective response rate of cadonilimab plus lenvatinib. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Cadonilimab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
8 May 2023to 30 Jun 2026
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

  • Signed Informed Consent Form (ICF).
  • Has a histologically confirmed diagnosis of endometrial carcinoma (EC). Has documented evidence of metastatic or recurrent EC which is not amenable to curative treatment with surgery and/or radiation therapy.
  • Failure or intolerance of standard first-line platinum-based chemotherapy regimen for EC.
  • Note: Prior adjuvant therapy is NOT counted as a systemic chemotherapeutic regimen for management of advanced EC. However, adjuvant chemotherapy could be counted as one prior regimen in patients who had recurrence during or within 12 months of completion of therapy. There is no restriction regarding hormonal therapy.
  • Age ≥ 18 years and ≤ 75 years.
  • Has measurable disease per RECIST v1.1.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy exceeds 3 months.
  • Has adequate organ function as defined by the following criteria:
  • Absolute neutrophil count (ANC) (≥1.5×109/L), hemoglobin of ≥90 g/L, platelets ≥100 ×109/L
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (however, patients with known liver metastasis who have AST or ALT level ≤ 5 × ULN may be enrolled)
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula)
  • 10. Women of childbearing potential should have a negative serum or urine pregnancy test prior to receiving the first dose of study treatment; and should be willing to use one acceptable contraception (i.e., oral contraceptives, condoms, intrauterine devices [IUDs]) throughout the period of taking study treatment and for at least 6 months after the last dose of study drug(s).

Who cannot join

  • Histologic types of carcinoma other than endometrial carcinoma.
  • Known or suspected allergy to any of study drugs.
  • Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or small molecule anti-angiogenic agent.
  • Has an active autoimmune disease requiring systemic therapy (i.e., with use of disease modifying drugs, corticosteroids or immunosuppressive drugs) in past 2 years. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.
  • Concurrent medical condition requiring the use of systemic steroid therapy (dose >10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of study intervention.
  • Has received anti-tumor treatment within 28 days, including but not limited to chemotherapy and radiotherapy or targeted therapy.
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  • Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with exception of alopecia and anemia.
  • Has an active infection requiring systemic therapy.
  • Clinically significant cardiovascular diseases, including but not limited to congestive heart failure (New York heart association [NYHA] class >2), unstable or severe angina, severe acute myocardial infarction within 6 months before enrollment, supraventricular or ventricular arrhythmia which need medical intervention, or QT interval male ≥ 450 ms, female ≥ 470 ms.
  • Hypertension that can not be well controlled through antihypertensive drugs (systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg).
  • Received major surgery with 28 days before the first medication.
  • Coagulation abnormalities (INR >2.0, PT >16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
  • Proteinuria ≥ (++) or 24 hours total urine protein >1.0g.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  • Has known active hepatitis B disease (hepatitis B virus [HBV] DNA ≥1×104/ml) or hepatitis C disease (hepatitis C virus [HCV] RNA ≥1×103/ml).
  • History of another malignancy in the previous 3 years, with a disease-free interval of <3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Has known active central nervous system metastases.
  • Has a known history of immunodeficiency including human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease.
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment. Note: Injection of inactivated viral vaccines against seasonal influenza are allowed.
  • Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Cetntre

    Guangzhou, 510060

Other trials in China

About this study

Official title: A Phase II Trial of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer

This is an open-label, multi-center Phase II study of cadonilimab (AK104) combined with lenvatinib in patients with advanced endometrial cancer. The primary objective is to evaluate objective response rate of cadonilimab plus lenvatinib.

Being tested
Cadonilimab, Lenvatinib
Keywords
Endometrial Cancer, Immune Checkpoint Inhibitors (ICIs), Anti-PD-1/CTLA4 bi-specific antibody, Antiangiogenic agents, Lenvatinib
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • CadonilimabDrug

    Also called AK104

    Injectable solution

  • LenvatinibDrug

    Also called Tyrosine Kinase Inhibitor

    Capsule

Study groups in NCT05824481
Study groupRoleWhat they receive
Cadonilimab + LenvatinibExperimentalSafety run-in stage. A dose de-escalation schedule is used in this phase. Dose Level 1: cadonilimab 10 mg/kg administered intravenously on day 1 and lenvatinib 16 mg administered orally once daily on a 21-day treatment cycle. If ≥2/6 patients experience a DLT, we will de-escalate to Dose Level 2: cadonilimab 10 mg/kg administered intravenously on day 1 and lenvatinib 12 mg administered orally once daily on a 21-day treatment cycle. Approximately 3-12 patients will be enrolled in the safety run-in phase. Expansion stage. The expansion stage will begin once the RP2D of lenvatinib have been determined in the safety run-in phase in order to assess antitumor activity of cadonilimab and lenvatinib combination. In expansion stage, cadonilimab 10 mg/kg and lenvatinib PR2D will be administered.
Receives: Drug: Cadonilimab; Drug: Lenvatinib

What is being measured

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

  1. Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences a dose limiting toxicities (DLT) during the first cycle.

    Measured: the first 21 days of treatment

  2. Recommended Phase 2 dose (RP2D)

    Determine the RP2D of lenvatnib

    Measured: the first 21 days of treatment

  3. Response Rate (ORR)

    ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: from the first drug administration up to two years

Secondary outcomes (5)

  1. Progression-free Survival (PFS)

    Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first.

    Measured: from the first drug administration up to two years

  2. Disease Control Rate (DCR)

    Proportion of patients whose best overall response is either CR, PR, or SD.

    Measured: from the first drug administration up to two years

  3. Duration of response (DOR)

    Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first.

    Measured: from the first drug administration up to two years

  4. Overall survival (OS)

    Time from the date of first study treatment administration to the date of death due to any cause.

    Measured: from the first drug administration up to 2 years

  5. Safety and tolerability

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

    Measured: up to 90 days after last study treatment administration

Timeline

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

  1. First posted21 Apr 2023
  2. Study start8 May 2023
  3. Primary completion31 Jul 2025
  4. Study completion30 Jun 2026 (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
Model description
Drug: Cadonilimab Drug: Lenvatinib
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05824481
Sponsor's protocol ID
B2023-099-01
Status last verified
Mar 2026
First submitted
9 Apr 2023
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou L, Zhao J, Li S, Liang H, Zhu D, Wang Y, Wu X, Yang H, Yin Q, Wang W, Yang X, Huang X, Lan C. Cadonilimab plus lenvatinib in advanced endometrial cancer: the multicenter single-arm phase II CLEAR-EC trial. Nat Commun. 2026 Sep 4;17(1):10537. doi: 10.1038/s41467-026-77467-3.

    PubMed 42838953

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab and Lenvatinib in people with Endometrial Cancer and Endometrial Adenocarcinoma, run by Sun Yat-sen University 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 14 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. 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?

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: the first 21 days of treatment). The study lists 3 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 NCT05824481, which also lists 1 linked publication.

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 10 Mar 2026.

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