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

NCT05557565 | Unknown Phase 2

• 1 other identifier: QL1706-206
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)

  The ORR assessed by the Independent Image Review Board (IRC) according to RECIST V1.1

  Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years

Secondary Outcomes (4)

• The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1

  Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years

• The Disease Control Rate (DOR) assessed by the Independent Image Review Board (IRC) and the investigator

  Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years

• The Progression-free survival (PFS) assessed by the Independent Image Review Board (IRC) and the investigator

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last QL1706 injection has been administered.

• Overall survival

  From date of enrollment until the date of death from any cause or date of lost to visit, assessed up to 2 years after the last QL1706 injection has been administered.

Study Arms (1)

QL1706 injection

EXPERIMENTAL

The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion

Drug: QL1706

Interventions

QL1706 DRUG

The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion

QL1706 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jihong Liu, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peizhen Wang, bachelor

CONTACT

18001246877; peizhen.wang@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 28, 2022
• Study Start: December 21, 2021
• Primary Completion: October 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)