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.
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.
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.
Single group
IN10018
Drug100 mg, orally, once daily
Nab-paclitaxel
Drug260 mg/m², IV infusion, Q3W
Cadonilimab
Drug10 mg/kg, IV infusion, Q3W
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
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
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
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