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

NCT04150575 | Unknown Phase 2

• 1 other identifier: HLX10-011-CC201
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

  up to 2 years

Secondary Outcomes (5)

• ORR

  up to 2 years

• PFS

  from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years

• 6-month PFS rate

  from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 6 months

• OS

  from the date of first dose until the date of death from any cause，assessed up to 2 years

• 6-month OS rate

  from the date of first dose until the date of 6-month

Study Arms (1)

HLX10

EXPERIMENTAL

HLX10+albumin-bound paclitaxel

Drug: HLX10+Albumin-Bound Paclitaxel

Interventions

HLX10+Albumin-Bound Paclitaxel 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.

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

HLX10

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate and have signed the informed consent form (ICF);
• Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF
• Patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).
• 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:
• Platinum-based drugs + taxanes;
• Platinum-based drugs + topotecan;
• Taxanes + topotecan.
• The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1(IRRC).
• Patients whose tumour specimens are tested positive for PD-L1 expression (CPS ≥ 1).
• An ECOG score of 0 or 1.
• Conforming to laboratory measurements;

You may not qualify if:

• Patients who have previously received albumin-bound paclitaxel.
• Patients with other active malignancies within 5 years or at the same time.
• Patients who are preparing for or have received an organ or bone marrow transplant.
• Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathological examination.
• Class III to IV cardiac insufficiency according to NYHA classification or an LVEF (left ventricular ejection fraction) \< 50% by cardiac colour Doppler.
• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 37153587 DERIVED

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

• lingying wu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

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: October 31, 2019
• First Posted: November 5, 2019
• Study Start: March 10, 2020
• Primary Completion: June 15, 2022
• Study Completion: September 15, 2022
• Last Updated: May 9, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)