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Cervical CancerPhase 2NCT06155396

A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer

A Phase 2 study testing Disitamab Vedotin and Zimberelimab in people with Cervical Cancer, run by RemeGen Co., Ltd. at 12 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Disitamab Vedotin and Zimberelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
12 sitesChina
Study dates
11 Jan 2024to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • LVEF ≥>50%
  • Female subjects should be surgically sterilised, post-menopausal or agree to use at least one medically approved contraceptive method during and for 6 months after the end of the study treatment period, must have had a negative blood pregnancy test within 7 days prior to study entry, and must be non-lactating.
  • Willingness and ability to comply with trial and follow-up procedure arrangements.

Who cannot join

  • 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;
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  • 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.
  • History of interstitial pneumonia, obstructive lung disease, drug-induced pneumonia, radiation pneumonia, idiopathic pneumonia or active pneumonia.
  • Clinically relevant pyelonephrosis cannot be alleviated by ureteral stents or percutaneous drainage.
  • Presence of active autoimmune disease requiring systemic therapy within 2 years prior to the start of study drug administration, allowing for relevant alternative therapy.
  • Other malignancy within 5 years prior to start of study drug administration.
  • Previous allogeneic haematopoietic stem cell transplantation.
  • Previous treatment with other Antibody-drug conjugateantibody-coupled drugs.
  • Known hypersensitivity to the drug vedicilizumab for injection and its components or to Zimberelimab injection and other monoclonal antibodies.
  • Have any other disease, metabolic abnormality, physical examination abnormality or laboratory test abnormality.
  • Estimated lack of patient adherence to participate in this clinical study.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jianmin Fang, Ph.D contact

+8610-58075763

Jianminfang@hotmail.com

12 sites in 1 country

China12 sites, 12 recruiting

  • Beijing Obstetrics and Gynecology Hospital ,Capital Medical University

    Beijing, Beijing Municipality, 100026

    Jinwei Miao, M.D

    Not yet recruiting

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui, 233000

    Yuzhi Li, M.D

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Keqiang Zhang, M.D.

    Not yet recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Ying Tang, M.D

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

    Xiaojuan Lv, M.D.

    Not yet recruiting

  • Shandong Cancer Hospital & Institute

    Jinan, Shandong, 250117

    Dapeng Li, M.D.

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

    Hongping Zhang, Ph.D

    Not yet recruiting

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi, 330008

    Meirong Liang, M.D

    Not yet recruiting

  • Guangxi Tumor Hospital

    Nanning, Guangxi, 530021

    Qingjie Zhang, M.D

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xiahua Wu, Ph.D

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110801

    Chunyan Wang, Ph.D

    Not yet recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300181

    Ke Wang, M.D

    Not yet recruiting

Other trials in China

About this study

Official title: A Single-Arm, Open- Label, Multicenter Phase II Study 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

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

Read the detailed description

This is a Phase II, Single-Arm ,multicenter, open-label clinical trial designed to evaluate safety and efficacy 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.The HER2-expressing is defined as: the HER2 IHC 3+ or 2+, or 1+.subjects with IHC 2+ require testing for FISH.

Conditions
Cervical Cancer
Being tested
Disitamab Vedotin, Zimberelimab
Keywords
HER2-expressing, Recurrent Cervical Cancer, Metastatic Cervical Cancer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Disitamab VedotinDrug

    Also called Disitamab Vedotin （RC48-ADC)

    2.0 mg/kg IV every 2 weeks

  • ZimberelimabDrug

    240mg IV every 2 weeks

Study groups in NCT06155396
Study groupRoleWhat they receive
Disitamab Vedotin + ZimberelimabExperimentalDisitamab Vedotin（RC48-ADC）with Zimberelimab arm
Receives: Drug: Disitamab Vedotin; Drug: Zimberelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety run-in ：Safety(adverse event)

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

    Measured: Up to approximately 2 years

  2. 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

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. 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

    Measured: Up to approximately 2 years

  2. Duration of Response (DOR)

    DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

    Measured: Up to approximately 2 years

  3. Disease Control Rate(DCR)

    Proportion of patients whose tumors shrank or stabilized for a certain period of time

    Measured: Up to approximately 2 years

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

    Progression-free survival (PFS) refers to the time from the date of first administration to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

    Measured: Up to approximately 2 years

  5. Overall survival (OS)

    Overall survival (OS) refers to the time from the date of first administration to the date of death of the subject.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2023
  2. Study start11 Jan 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06155396
Sponsor's protocol ID
RC48-C030
Status last verified
Nov 2023
First submitted
23 Nov 2023
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Disitamab Vedotin and Zimberelimab in people with Cervical Cancer, run by RemeGen Co., Ltd. at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianmin Fang, Ph.D (+8610-58075763, Jianminfang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety run-in ：Safety(adverse event) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06155396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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