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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Xiangyang Central Hospital
RECRUITING
Xiangyang
Contact Information
Primary
Peng Wu, Ph.D
pengwu8626@tjh.tjmu.edu.cn
+86 13995573729
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 25
Treatments
Experimental: Study group
IN10018 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.
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov

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