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Advanced Breast CancerPhase 1/2NCT03052634

A Study of RC48-ADC in Subjects With Advanced Breast Cancer

A Phase 1/2 study testing RC48-ADC 1.5 mg/kg (HER2 Positive), RC48-ADC 2.0 mg/kg (HER2 Positive) and RC48-ADC 2.5 mg/kg (HER2 Positive) in people with Advanced Breast Cancer, run by RemeGen Co., Ltd. at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection in subjects with advanced breast cancer with HER2 positive or HER2 low expression Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
RC48-ADC 1.5 mg/kg (HER2 Positive), RC48-ADC 2.0 mg/kg (HER2 Positive) and RC48-ADC 2.5 mg/kg (HER2 Positive)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
7 sitesChina
Study dates
23 Dec 2016to 7 Apr 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary signed informed consent;
  • Female, aged between 18 to 70 years;
  • ECOG performance status score of 0 or 1;
  • Life expectancy greater than 12 weeks；
  • Patients with locally advanced or metastatic breast cancer diagnosed by histology or cytology, and:
  • Core cohort: standard treatment is ineffective (the disease progresses or has no remission after treatment) or cannot tolerate standard treatment, or HER2 positive who cannot receive standard treatment (immunohistochemistry is 2+ and confirmed by fluorescence in situ hybridization [FISH] Positive, or immunohistochemical 3+) patients;
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  • Explorative cohort:standard treatment is ineffective (the disease progresses or has no remission after treatment) or cannot tolerate standard treatment, or had no optional standard treatment for HER2 immunohistochemistry 2+ with FISH negative or HER2 immunohistochemistry 1+ (FISH negative or untested). Subjects in the explorative cohort can provide HER2 detection of tumor primary or metastatic site specimens;
  • Measurable lesion according to the RECIST 1.1;
  • Adequate organ function:
  • (1)absolute neutrophil count(ANC) >= 1.5 x 10(9)/L; (2) platelets>=10010(9)/L; (3)Total serum bilirubin <=1.5ULN; (4)serum aspartate transaminase (AST）and serum alanine transaminase (ALT) <=2.5ULN, or AST and ALT<=5ULN with hepatic metastasis; (5) Serum creatinine clearance rate >= 45 mL/min; (6) INR<=1.5ULN and APTT<=1.5ULN; 8.Women of child-bearing potential and men must agree to use adequate contraception (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices, complete sexual abstinence, or sterilized partner) prior to study entry and during the period of therapy and for 6 months after the last dose of study drug; 9.Left ventricular ejection fraction (LVEF) >= 50%.

Who cannot join

  • Women who are pregnant (positive blood test before medication) or breastfeeding;
  • Patients received anti-cancer therapy within 4 weeks before study drug treatment;, including chemotherapy, radiotherapy, surgery or hormone therapy, molecular targeted therapy (including trastuzumab etc.); Using Trastuzumab emtansine(T-DM1) or participating in the clinical trial on ADC drugs targeting HER2 and bispecific antibodies targeting HER2;
  • The patient have third interstitial fluid (a large number of pleural effusion or ascites) which has clinical symptom or can not be controlled by drainage or other methods;
  • Received Palliative radiation therapy for bone metastases within 2 weeks before study drug treatment;
  • Toxicity of previous anti-tumor treatment has not recovered to CTCAE [version 4.0] 0-1, except for hair loss;
  • Participated in other clinical trials within 4 weeks;
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  • Known hypersensitivity or delayed hypersensitivity to the some components of RC48-ADC or similar drugs;
  • The active infection with clinical significance according to the researcher's judgment;
  • Diagnosed with HBsAg or HBcAb positive and HBV DNA positive, or HCV Ab positive, or HIV Ab positive.
  • Have a history of immunodeficiency, including a positive HIV test, or other acquired, congenital immunity Epidemic defects, or a history of organ transplantation;
  • Uncontrolled systemic diseases such as diabetes, hypertension, Pulmonary fibrosis, acute lung disease, interstitial lung disease, etc.
  • Congestive heart failure with grade 2 or higher (including grade 2) of the New York Institute of Cardiology (NYHA) of the United States in the history of diseases such as acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to entry ;
  • Insufficient adherence to participate in this clinical study;
  • Patients who had received systemic steroid therapy for a long time(Patients who had received systemic steroid therapy for short time and stopped drug more than 2 weeks could be enrolled );
  • Primary brain or metastatic tumor;
  • Peripheral neuropathy with grade≥2;
  • People with a history of mental illness that is difficult to control.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • The first bethune hospital of jilin unversity

    Changchun, Jilin

  • Zhejiang cancer hospital

    Hangzhou, Zhejiang

  • Affiliated cancer hospital of Harbin medical university

    Harbin

  • The fourth hospital of Hebei medical university

    Hebei

  • Jiangsu Cancer Hospital

    Nanjing

  • Liaoning cancer hospital & institute

    Shenyang, Liaoning

Other trials in China

About this study

Official title: A Phase Ib Study to Evaluate the Efficacy, Safety and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Breast Cancer With HER2 Positive or HER2 Low Expression

This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection in subjects with advanced breast cancer with HER2 positive or HER2 low expression

Being tested
RC48-ADC 1.5 mg/kg (HER2 Positive), RC48-ADC 2.0 mg/kg (HER2 Positive), RC48-ADC 2.5 mg/kg (HER2 Positive), RC48-ADC 2.0 mg/kg (HER2 Low Expression)

What participants receive

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

  • RC48-ADC 1.5 mg/kg (HER2 Positive)Drug

    15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 1.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

  • RC48-ADC 2.0 mg/kg (HER2 Positive)Drug

    15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.0mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

  • RC48-ADC 2.5 mg/kg (HER2 Positive)Drug

    15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

  • RC48-ADC 2.0 mg/kg (HER2 Low Expression)Drug

    45 advanced breast cancer participants with HER2 Low Expression will be treated with RC48-ADC at a dose of 2.0 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

Study groups in NCT03052634
Study groupRoleWhat they receive
RC48-ADC 1.5 mg/kg (HER2 Positive)ExperimentalNot described
Receives: Drug: RC48-ADC 1.5 mg/kg (HER2 Positive)
RC48-ADC 2.0 mg/kg (HER2 Positive)ExperimentalNot described
Receives: Drug: RC48-ADC 2.0 mg/kg (HER2 Positive)
RC48-ADC 2.5 mg/kg (HER2 Positive)ExperimentalNot described
Receives: Drug: RC48-ADC 2.5 mg/kg (HER2 Positive)
RC48-ADC 2.0 mg/kg (HER2 Low Expression)ExperimentalNot described
Receives: Drug: RC48-ADC 2.0 mg/kg (HER2 Low Expression)

What is being measured

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

  1. RP2D

    Recommended Phase II Dose

    Measured: Estimated 2 year

Secondary outcomes (6)

  1. Cmax

    Maximum Observed Plasma Concentration

    Measured: Estimated 2 year

  2. AUC

    Area Under Curve

    Measured: Estimated 2 year

  3. Tmax

    Time for Cmax

    Measured: Estimated 2 year

  4. Overall response Rate (ORR)

    As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - to estimate the anti-tumor activity of RC48-ADC.

    Measured: Estimated 2 year

  5. Clinical Benefit Rate (CBR)

    Clinical Benefit Rate was defined as the percentage of patients with complete remission (CR) partial remission (PR) stable (SD) not less than 4 months.

    Measured: Estimated 2 year

  6. Progression Free Survival (PFS)

    Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Estimated 2 year

Timeline

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

  1. First posted14 Feb 2017
  2. Study start23 Dec 2016
  3. Primary completion31 Jul 2022
  4. Study completion7 Apr 2023

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052634
Sponsor's protocol ID
C003 CANCER
Status last verified
Jan 2022
First submitted
4 Jan 2017
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang J, Liu Y, Zhang Q, Li W, Feng J, Wang X, Fang J, Han Y, Xu B. Disitamab vedotin, a HER2-directed antibody-drug conjugate, in patients with HER2-overexpression and HER2-low advanced breast cancer: a phase I/Ib study. Cancer Commun (Lond). 2024 Jul;44(7):833-851. doi: 10.1002/cac2.12577. Epub 2024 Jun 28.

    PubMed 38940019

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RC48-ADC 1.5 mg/kg (HER2 Positive), RC48-ADC 2.0 mg/kg (HER2 Positive) and RC48-ADC 2.5 mg/kg (HER2 Positive) in people with Advanced Breast Cancer, run by RemeGen Co., Ltd. at 7 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D (time frame: Estimated 2 year). 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 NCT03052634, which also lists 1 linked publication.

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 18 Dec 2023.

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