NCT06155396

Brief Summary

This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Jan 2024

Typical duration for phase_2

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jan 2024Dec 2027

First Submitted

Initial submission to the registry

November 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 11, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 28, 2024

Status Verified

November 1, 2023

Enrollment Period

3.5 years

First QC Date

November 23, 2023

Last Update Submit

February 26, 2024

Conditions

Cervical Cancer

Keywords

HER2-expressingRecurrent Cervical CancerMetastatic Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Safety run-in ：Safety(adverse event)

    to evaluate safety including adverse event rate and adverse event grade.

    Up to approximately 2 years

  • Dose extension period ：Objective Response Rate (ORR)

    The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed

    Up to approximately 2 years

Secondary Outcomes (5)

  • Objective Response Rate(ORR)

    Up to approximately 2 years

  • Duration of Response (DOR)

    Up to approximately 2 years

  • Disease Control Rate(DCR)

    Up to approximately 2 years

  • Progression-free survival (PFS), evaluated by the investigator

    Up to approximately 2 years

  • Overall survival (OS)

    Up to approximately 2 years

Study Arms (1)

Disitamab Vedotin + Zimberelimab

EXPERIMENTAL

Disitamab Vedotin（RC48-ADC）with Zimberelimab arm

Drug: Disitamab VedotinDrug: Zimberelimab

Interventions

Disitamab VedotinDRUG

2.0 mg/kg IV every 2 weeks

Also known as: Disitamab Vedotin （RC48-ADC)
Disitamab Vedotin + Zimberelimab
ZimberelimabDRUG

240mg IV every 2 weeks

Disitamab Vedotin + Zimberelimab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a)Patients with histologically confirmed HER2-expressing recurrent or metastatic cervical cancer who have failed at least 1 line of standard platinum-containing therapy ; b) Not suitable for surgery or radiotherapy;
  • Voluntarily agreed to participate in the study and signed an informed consent form.
  • Female, age ≥ 18 years
  • Expected survival ≥ 12 weeks
  • Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH.
  • Central laboratory confirmation of PD-L1 expression
  • Measurable disease according to RECIST 1.1 standard
  • ECOG physical condition 0 or 1 point
  • Adequate organ function, criteria should be met during the screening period
  • ANC ≥1,500/µL
  • platelet count ≥100,000/μL
  • hemoglobin ≥9.0 g/dL
  • total bilirubin ≤1.5 × upper limit normal (ULN) OR direct bilirubin ≤ULN for subjects with total bilirubin \>1.5 × ULN. Serum bilirubin ≤3× ULN for subjects with Gilbert's disease
  • CrCl ≥50 mL/min (measured by the Cockcroft-Gault formula as applicable, or 24-hour urine).
  • ALT and AST ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases
  • +3 more criteria

You may not qualify if:

  • Have central nervous system metastases and/or carcinomatous meningitis.
  • Received anti-tumour therapy or participated in another clinical study treatment within 4 weeks prior to the start of study treatment.
  • Toxicity due to previous antineoplastic therapy has not recovered to NCI-CTCAE (version 5.0) grade 0-1.
  • Major surgery with incomplete recovery within 4 weeks prior to start of study dosing.
  • Serum virology examination (based on the normal value of the research center) :
  • HBsAg test results were positive, and HBV DNA copy number was positive;
  • HCVAb test results were positive (HCV RNA PCR test results were negative only to be included in this study);
  • HIVAb tested positive
  • Have received a live or live attenuated vaccine within 4 weeks prior to the start of study dosing; or plan to receive any vaccine during the study period
  • Grade 3 or higher heart failure
  • History of gastrointestinal perforation and/or fistula within the previous 6 months
  • Serious arterial/venous thrombotic event or cardiovascular accident within 1 year prior to study drug administration
  • Presence of active or progressive infection requiring systemic therapy, with severe infection within 4 weeks prior to first dose;
  • Active TB.
  • Presence of systemic disease not under stable control as judged by the investigator.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, 233000, China

NOT YET RECRUITING

Beijing Obstetrics and Gynecology Hospital ,Capital Medical University

Beijing, Beijing Municipality, 100026, China

NOT YET RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

NOT YET RECRUITING

Guangxi Tumor Hospital

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

NOT YET RECRUITING

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, 330008, China

NOT YET RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China

NOT YET RECRUITING

Shandong Cancer Hospital & Institute

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300181, China

NOT YET RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

NOT YET RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

disitamab vedotinzimberelimab

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jianmin Fang, Ph.D

    RemeGen Co., Ltd.

    STUDY DIRECTOR

Central Study Contacts

Jianmin Fang, Ph.D

CONTACT

+8610-58075763Jianminfang@hotmail.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

November 23, 2023

First Posted

December 4, 2023

Study Start

January 11, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 28, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(12)