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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

Primary Purpose

Cervical Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HLX10+Albumin-Bound Paclitaxel

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. Platinum-based drugs + taxanes;
2. Platinum-based drugs + topotecan;
3. 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;

Exclusion Criteria:

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.

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.

Sites / Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HLX10

Arm Description

HLX10+albumin-bound paclitaxel

Outcomes

Primary Outcome Measures

ORR

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

Secondary Outcome Measures

ORR

Objective response rate (ORR) (assessed by IRRC as per iRECIST, and by the investigator as per RECIST v1.1 and iRECIST, respectively)

PFS

Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 and iRECIST, respectively)

6-month PFS rate

6-month progression-free survival rate

Overall survival

6-month OS rate

6-month overall survival rate

Full Information

NCT ID

NCT04150575

First Posted

October 31, 2019

Last Updated

May 4, 2022

Sponsor

Shanghai Henlius Biotech

1. Study Identification

Unique Protocol Identification Number

NCT04150575

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 10, 2020 (Actual)

Primary Completion Date

June 15, 2022 (Anticipated)

Study Completion Date

September 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Henlius Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HLX10

Arm Type

Experimental

Arm Description

HLX10+albumin-bound paclitaxel

Intervention Type

Drug

Intervention Name(s)

HLX10+Albumin-Bound Paclitaxel

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

ORR

Description

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

Time Frame

up to 2 years

Secondary Outcome Measure Information:

Title

ORR

Description

Objective response rate (ORR) (assessed by IRRC as per iRECIST, and by the investigator as per RECIST v1.1 and iRECIST, respectively)

Time Frame

up to 2 years

Title

PFS

Description

Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 and iRECIST, respectively)

Time Frame

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

Title

6-month PFS rate

Description

6-month progression-free survival rate

Time Frame

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

Title

Description

Overall survival

Time Frame

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

Title

6-month OS rate

Description

6-month overall survival rate

Time Frame

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

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

lingying wu

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital, Chinese Academy of Medical Sciences

City

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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