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New treatment option for Cervical Adenocarcinoma
Official title IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial
ClinicalTrials.gov ID: NCT06654011
What this study is testing
What is IN10018?
IN10018 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for cervical adenocarcinoma.
Also referred to as BI 853520.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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...
- Patients must have had at least one prior systemic chemotherapeutic regimen for metastatic, recurrent or persistent carcinoma of the cervix. (Note...
- Patients must have measurable disease per REClST 1.1; measurable lesions are defined as those that can be accurately measured in at least one...
- Eastern Cooperative Oncology Group score 0-1.
You likely can't join if
- Patients with cervical cancer histologically diagnosed as squamous cell carcinoma, usual-type adenocarcinoma, clear cell carcinoma, adenosquamous...
- 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...
- HIV infection or a positive test for acquired immunodeficiency syndrome (AIDS).
See the full eligibility criteria
- 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...
- 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...
- Eastern Cooperative Oncology Group score 0-1.
- Life expectancy exceeds 3 months.
- 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...
- 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...
- Willing to participate in this study, and sign the informed consent.
- 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...
- HIV infection or a positive test for acquired immunodeficiency syndrome (AIDS).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Xiangyang, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China; Xiangyang, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.