A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer

Qilu Pharmaceutical

Status and phase

Enrolling

Phase 2

Conditions

Cervical Cancer

Treatments

Drug: QL1706

Study type

Interventional

Funder types

Industry

Identifiers

NCT05557565

QL1706-206

Details and patient eligibility

About

This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.

Full description

This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer who have failed at least first-line platinum-containing standard therapy.

The study was divided into screening period/baseline, treatment period, and post-treatment follow-up period. Efficacy evaluation and safety monitoring should be performed throughout the study.

Enrollment

150 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The subject will participate voluntarily and sign the informed consent form.
Female, aged ≥18 years when signing the informed consent form.
Recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy.
At least one measurable lesion is needed.
The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
Adequate reserves of organ function is needed.

Exclusion criteria

Active autoimmune disease.
Central nervous system (CNS) metastasis.
Concomitant diseases such as cardiovascular and cerebrovascular diseases.
Fistula of female genital tract.
Diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment.
Previous recipients of immune checkpoint inhibitors.
Received systemic antitumor drugs such as chemotherapy and targeted therapy within 4 weeks before the first use of the experimental drug; Received proprietary Chinese medicine with anti-tumor indications within 2 weeks before the first use of the experimental drug.
Received radical concurrent chemoradiotherapy or adjuvant chemoradiotherapy within 12 weeks before the first use of the investigational drug; Received palliative radiotherapy (e.g., reductive radiotherapy for pain or bleeding) or other local treatments (e.g., radiofrequency ablation, transarterial chemoembolization, etc.) within 2 weeks before the first use of the investigational drug.
History of immunodeficiency.
History of allogeneic hematopoietic stem cell transplantation or organ transplantation.