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Cervical AdenocarcinomaPhase 2NCT06654011

IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial

A Phase 2 study testing IN10018, Nab-paclitaxel and Cadonilimab in people with Cervical Adenocarcinoma and Gastric-type Endocervical Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Gastric-type adenocarcinoma of the cervix is the most commonly diagnosed HPV-independent subtype of cervical cancer, characterized by a poor prognosis and limited responsiveness to existing therapies. Therefore, the exploration of new treatment modalities is critically important. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
IN10018, Nab-paclitaxel and Cadonilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesChina
Study dates
17 Feb 2025to 1 Nov 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

  • Females 18-75 years of age.
  • Patients must have metastatic, recurrent or persistent gastric-type adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
  • Patients must have had at least one prior systemic chemotherapeutic regimen for metastatic, recurrent or persistent carcinoma of the cervix. (Note: Prior adjuvant therapy is NOT counted as a systemic chemotherapeutic regimen for management of metastatic, recurrent or persistent carcinoma of the cervix, adjuvant therapy includes cisplatin given concurrent with primary radiation therapy (CCRT).
  • Patients must have measurable disease per REClST 1.1; measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded as ≥ 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI); a lymph node must be ≥ 15 mm in short axis.
  • Eastern Cooperative Oncology Group score 0-1.
  • Life expectancy exceeds 3 months.
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  • AEs due to previous treatments should be resolved to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy are eligible.
  • NEU ≥ 1.5*10^9 /L, Platelet ≥ 75×10^9 /L, Hemoglobin ≥ 90 g/L; Serum creatinine ≤ 1.5 times the upper limit of normal (ULN).; Urinary protein < 2+ or 24h urinary protein quantity < 1.0 g; AST and ALT ≤ 2.5 times ULN; Total bilirubin ≤ 1.5 times ULN; Albumin levels ≥ 28 g/L; Coagulation function: Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times the ULN.
  • Female participants must test negative for HCG in urine or blood, except in cases of menopause or prior hysterectomy. Female patients of childbearing potential and their partners must use effective contraception during the study and for 6 months after the final dose of the study drug.
  • Willing to participate in this study, and sign the informed consent.

Who cannot join

  • Patients with cervical cancer histologically diagnosed as squamous cell carcinoma, usual-type adenocarcinoma, clear cell carcinoma, adenosquamous carcinoma, small cell carcinoma, or any non-gastric-type adenocarcinoma.
  • Participate in other drug clinical trials at the same time.
  • Known hypersensitivity to any component of the IN10018 formulation or to cadonilimab.
  • Patients with active autoimmune disease or a history of autoimmune disorders.
  • Patients with concomitant conditions requiring immunosuppressive medications or systemic or absorbable local corticosteroids at immunosuppressive doses. The use of prednisone >10 mg/day or an equivalent dose is prohibited within 2 weeks prior to the first administration of the investigational drug.
  • HIV infection or a positive test for acquired immunodeficiency syndrome (AIDS).
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  • Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Necrotic lesions identified within 4 weeks prior to enrollment, where there is a high risk of major bleeding as determined by the investigator.
  • Severe infections occurring within 4 weeks prior to the first dose of study treatment.
  • Known active tuberculosis (TB) or suspicion of active TB.
  • Untreated chronic hepatitis B infection or hepatitis B virus (HBV) carriers with HBV DNA levels exceeding 1000 IU/mL, or patients with active hepatitis C infection.
  • Patients with known leptomeningeal disease, spinal cord compression, or active brain metastases.
  • Uncontrolled severe medical conditions that, in the investigator's judgment, would interfere with the patient's ability to receive study treatment, including but not limited to severe cardiovascular disease, cerebrovascular disease, uncontrolled diabetes, or uncontrolled infections.
  • Receipt of a live vaccine within 4 weeks prior to the first dose of study treatment. Note: Inactivated seasonal influenza vaccines are permitted.
  • Pregnant or breastfeeding female patients, or female patients of childbearing potential who refuse to use effective contraception.
  • Patients with symptomatic or unstable third-space fluid accumulations (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage.
  • Patients with a prior genetic test report indicating mutations associated with hyperprogression under immunotherapy, such as MDM2/4 amplification or EGFR mutations.
  • Not eligible for the study judged by researchers.

Trial locations and contacts

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

Peng Wu, Ph.D contact

+86 13995573729

pengwu8626@tjh.tjmu.edu.cn

China2 sites, 2 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Peng Wu, Ph.D, +86 13995573729, pengwu8626@tjh.tjmu.edu.cn

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441000

    Xiaomin Qin, +86 13487120205, 13487120205@163.com

    Recruiting

Other trials in China

About this study

Official title: IN10018 Plus Nab-Paclitaxel and Cadonilimab for Metastatic, Recurrent, or Persistent Gastric-Type Adenocarcinoma of the Cervix: A Multicenter, Single-Arm, Phase II Trial

Gastric-type adenocarcinoma of the cervix is the most commonly diagnosed HPV-independent subtype of cervical cancer, characterized by a poor prognosis and limited responsiveness to existing therapies. Therefore, the exploration of new treatment modalities is critically important. This is an open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of IN10018 plus nab-paclitaxel and cadonilimab in the treatment of adult women with metastatic, recurrent, or persistent gastric-type adenocarcinoma of the cervix.

Read the detailed description

Subjects will receive IN10018 at a dose of 100 mg orally once daily, in combination with nab-paclitaxel at 260 mg/m² and cadonilimab at 10 mg/kg, both administered via intravenous infusion on Day 1 of each 3-week cycle. Tumor assessments will be conducted every 2 cycles throughout the treatment period. If the therapy proves effective, chemotherapy will continue for up to 6 cycles. Upon completion of chemotherapy, maintenance therapy with cadonilimab and IN10018 will begin and continue until either disease progression or the emergence of intolerable toxicity.

Being tested
IN10018, Nab-paclitaxel, Cadonilimab

What participants receive

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

  • IN10018Drug

    Also called BI 853520

    100 mg, orally, once daily

  • Nab-paclitaxelDrug

    Also called Albumin-bound paclitaxel

    260 mg/m², IV infusion, Q3W

  • CadonilimabDrug

    Also called AK104

    10 mg/kg, IV infusion, Q3W

Study groups in NCT06654011
Study groupRoleWhat they receive
Study groupExperimentalIN10018 is administered orally at a dose of 100 mg once daily; cadonilimab is given at a dose of 10 mg/kg via intravenous infusion on Day 1 of each cycle, every 3 weeks; and nab-paclitaxel is administered at a dose of 260 mg/m² via intravenous infusion on Day 1 of each cycle, also every 3 weeks. Patients will undergo a maximum of 6 cycles of this combination chemotherapy. Following this regimen, maintenance therapy will consist of a combination of cadonilimab and IN10018.
Receives: Drug: IN10018; Drug: Nab-paclitaxel; Drug: Cadonilimab

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of the participants in the ITT population who have a complete response (CR) or partial response (PR). The ORR will be assessed by a blind independent central reviewer per RECIST 1.1

    Measured: Every 6 weeks from the time of the first dose of the study drug until the completion of treatment, lasting approximately 18 weeks.

Secondary outcomes (2)

  1. Progression-free survival (PFS)

    PFS is defined as the time from the first dose of study treatment/randomization to the first documentation of disease progression or death due to any cause, whichever comes first

    Measured: 2 years

  2. Disease Control Rate (DCR)

    DCR is defined as the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) following treatment. The DCR will be assessed by a blind independent central reviewer per RECIST 1.1

    Measured: Every 6 weeks from the time of the first dose of the study drug until the completion of treatment, lasting approximately 18 weeks.

Timeline

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

  1. First posted23 Oct 2024
  2. Study start17 Feb 2025
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Nov 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
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06654011
Sponsor's protocol ID
UHCT240895
Status last verified
Jan 2026
First submitted
20 Oct 2024
Last updated
13 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Ethical and legal considerations necessitate the protection of participants' privacy, particularly when dealing with sensitive data that may identify individuals. Additionally, if data analyses remain incomplete, disclosing individual participant data (IPD) could compromise the integrity of the results and lead to hasty conclusions.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IN10018, Nab-paclitaxel and Cadonilimab in people with Cervical Adenocarcinoma and Gastric-type Endocervical Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 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 10 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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 Peng Wu, Ph.D (+86 13995573729, pengwu8626@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Every 6 weeks from the time of the first dose of the study drug until the completion of treatment, lasting approximately 18 weeks.). 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 NCT06654011.

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 13 Jan 2026.

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