A Clinical Study to Evaluate Efficacy and Safety of HLX10 Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy

NCT ID: NCT04150575

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2022-09-15

Brief Summary

This is a single-arm, open-label, multicentre, phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.All enrolled patients will receive the treatment with HLX10 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity. Albumin-bound paclitaxel may be used for up to 6 cycles and HLX10 for up to 2 years.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLX10

HLX10+albumin-bound paclitaxel

Group Type: EXPERIMENTAL

HLX10+Albumin-Bound Paclitaxel

Intervention Type: DRUG

HLX10: 4.5 mg/kg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and HLX10 for up to 2 years.

Interventions

HLX10+Albumin-Bound Paclitaxel

HLX10: 4.5 mg/kg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and HLX10 for up to 2 years.

Intervention Type: DRUG

Other Intervention Names

HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

Eligibility Criteria

Inclusion Criteria

1. Voluntarily participate and have signed the informed consent form (ICF);

2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF

3. Patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).

4. Patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy. First-line chemotherapy includes any of the following:

1. Platinum-based drugs + taxanes;

2. Platinum-based drugs + topotecan;

3. Taxanes + topotecan.

5. The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1(IRRC).

6. Patients whose tumour specimens are tested positive for PD-L1 expression (CPS ≥ 1).

7. An ECOG score of 0 or 1.

8. Conforming to laboratory measurements;

Exclusion Criteria

1. Patients who have previously received albumin-bound paclitaxel.

2. Patients with other active malignancies within 5 years or at the same time.

3. Patients who are preparing for or have received an organ or bone marrow transplant.

4. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

5. Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathological examination.

6. Class III to IV cardiac insufficiency according to NYHA classification or an LVEF (left ventricular ejection fraction) < 50% by cardiac colour Doppler.

8.With human immunodeficiency virus (HIV) infection. 9.With active pulmonary tuberculosis. 10.Have received any T-cell costimulatory or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

lingying wu

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

References

An J, Li X, Wang J, Zhu L, An R, Jiang K, Huang Y, Wang K, Li G, Wang C, Yuan J, Hou X, Yang G, Li J, Wang Q, Zhu J, Wu L. Efficacy and safety of serplulimab plus nab-paclitaxel in previously treated patients with PD-L1-positive advanced cervical cancer: a phase II, single-arm study. Front Immunol. 2023 Apr 21;14:1142256. doi: 10.3389/fimmu.2023.1142256. eCollection 2023.

Reference Type: DERIVED

PMID: 37153587 (View on PubMed)

Other Identifiers

HLX10-011-CC201

Identifier Type: -

Identifier Source: org_study_id