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

• ClinicalTrials.gov Identifier: NCT04150575
• Recruitment Status: Active, not recruiting
• First Posted: November 5, 2019
• Last Update Posted: March 19, 2021
• Sponsor: Shanghai Henlius Biotech
• Information provided by (Responsible Party): Shanghai Henlius Biotech

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer	Drug: HLX10+Albumin-Bound Paclitaxel	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 143 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-Arm, Open-Label, Multicentre, Phase II Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy
• Actual Study Start Date: March 10, 2020
• Estimated Primary Completion Date: June 15, 2021
• Estimated Study Completion Date: September 15, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: HLX10; HLX10+albumin-bound paclitaxel	Drug: 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.; Other Name: HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

Outcome Measures

Primary Outcome Measures :

1. ORR [ Time Frame: up to 2 years ]
   Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

Secondary Outcome Measures :

1. ORR [ Time Frame: up to 2 years ]
   Objective response rate (ORR) (assessed by IRRC as per iRECIST, and by the investigator as per RECIST v1.1 and iRECIST, respectively)
2. PFS [ Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years ]
   Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 and iRECIST, respectively)
3. 6-month PFS rate [ Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 6 months ]
   6-month progression-free survival rate
4. OS [ Time Frame: from the date of first dose until the date of death from any cause，assessed up to 2 years ]
   Overall survival
5. 6-month OS rate [ Time Frame: from the date of first dose until the date of 6-month ]
   6-month overall survival rate

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Sponsors and Collaborators

Shanghai Henlius Biotech

Investigators

• Principal Investigator: lingying wu; Cancer Institute and Hospital, Chinese Academy of Medical Sciences

More Information

• Responsible Party: Shanghai Henlius Biotech
• ClinicalTrials.gov Identifier: NCT04150575
• Other Study ID Numbers: HLX10-011-CC201
• First Posted: November 5, 2019
• Last Update Posted: March 19, 2021
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Disease Progression; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; Pathologic Processes; Paclitaxel; Albumin-Bound Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action