Breast CancerPhase 2NCT06642545
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
A Phase 2 study testing Disitamab Vedotin, RC148 and Albumin-bound Paclitaxone in people with Breast Cancer, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Disitamab Vedotin, RC148 and Albumin-bound Paclitaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 1 Oct 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate in the study and sign the informed consent form
- Stage III unresectable locally advanced or Stage IV metastatic breast cancer.
- Subjects must be willing and able to provide a tumor tissue block and/or unstained pathology slides, with priority given to the most recent metastatic lesions that have not previously been subjected to radiotherapy. If this is not feasible or available, then a tumor tissue block (or fresh tissue sections) obtained from locally recurrent lesions should be provided. Freshly obtained tissue is preferred over archived tissue. The provided tissue will be used for biomarker testing and must be suitable for analysis of HER2 expression and PD-L1 expression
- Invasive breast tumor tissue has been confirmed as HER2 low expression by the central laboratory
- Invasive tumor tissue is negative for hormone receptors (HR), defined as immunohistochemistry (IHC) testing showing that the proportion of cells with positive nuclear staining for both ER and PgR in invasive cancer is less than 1%. For patients with weakly positive ER/PgR (1% to 10% of tumor cell nuclei positive), those who are not suitable for endocrine therapy after thorough evaluation by the investigator, and with approval from the sponsor after communication, may be included in this study
- For HR-negative, HER2-low expressing unresectable locally advanced or metastatic breast cancer: locally recurrent and unresectable or previously untreated metastatic breast cancer; or those who have completed curative treatment (excluding radiotherapy) (e.g., the date of surgery for the primary breast tumor or the last date of adjuvant therapy administration, whichever is later), with an interval of ≥6 months from the first documented local or distant disease recurrence. For subjects who received taxane drugs during the (neo)adjuvant therapy phase, there must be an interval of ≥12 months from the last taxane administration
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- ECOG performance status of 0 or 1
- According to the RECIST v1.1 criteria, there must be at least one measurable lesion (for lesions that have previously been irradiated, if the lesion can be measured according to the RECIST v1.1 criteria and there is evidence of significant progression after radiotherapy, the lesion can be considered a target lesion)
- Expected survival of at least 12 weeks
- Hematologic and organ function criteria to be met within 7 days prior to the first dose of study medication (with normal values based on the clinical trial center's standards, and no blood transfusions, hematopoietic growth factors, albumin, or blood products within 14 days prior to the test):
- Hemoglobin ≥ 90 g/L Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L Platelet count ≥ 100 × 10^9/L Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN (for subjects with total bilirubin > 1.5 × ULN). Total bilirubin ≤ 3 × ULN (for subjects with Gilbert's disease) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN (if liver metastases are present) International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN Creatinine clearance (CrCl) calculated by the Cockcroft-Gault formula ≥ 40 mL/min, or serum creatinine ≤ 1.5 × ULN Urine routine test shows urine protein < 2+; if urine protein ≥ 2+, the 24-hour urine protein quantification result must be < 1 g.
- Female subjects of childbearing potential who meet the following conditions:
- A serum pregnancy test (with a minimum sensitivity of 25 mIU/mL or equivalent units of β-human chorionic gonadotropin [β-hCG]) must be negative within 7 days prior to the first dose of study intervention. Subjects with a false-positive result that is confirmed not to be pregnant are eligible to participate in the study.
- Must agree to use contraception during the study and for at least 6 months after the last dose of study medication. No breastfeeding or egg donation within 6 months.
- If sexual activity could lead to pregnancy, they must use at least one acceptable form of contraception from the time of informed consent until at least 6 months after the last dose of study medication.
- Male subjects of childbearing potential who meet the following conditions:
- Must agree to abstain from donating sperm from the start of the study until at least 6 months after the last dose of study medication.
- If having sexual intercourse with a person of childbearing potential that could lead to pregnancy, must consistently use at least one acceptable form of contraception throughout the study and for at least 6 months after the last dose of study medication.
- If having sexual intercourse with a pregnant or breastfeeding partner, must use condoms from the time of informed consent until at least 6 months after the last dose of study medication.
- Capable of understanding the trial requirements and willing and able to comply with the trial and follow-up procedures.
Who cannot join
- Having previously received anti-HER2 treatment, including ADC (Antibody-Drug Conjugates).
- Having previously received immunotherapy, including anti PD-(L)1 or anti PD-(L)2 drugs, or drugs that directly target another stimulatory or co-inhibitory T-cell receptor (such as CD137, CTLA-4, OX-40) during the locally advanced or metastatic stage (except if the last administration was ≥12 months prior to recurrence or progression, using [neo]adjuvant anti PD-(L)1).
- Excluding subjects with brain metastases or leptomeningeal metastases. Subjects with treated brain metastases (surgery and/or radiotherapy) are eligible for inclusion if they meet the following criteria:
- Subjects who have received treatment for brain metastases may be considered for participation in this study if they have not experienced disease progression as determined by imaging studies within 4 weeks prior to the first dose of study treatment.
- They must have discontinued the use of corticosteroids or anticonvulsant therapy at least 14 days before the first dose of study
- Use of investigational drugs or undergoing major surgery within 4 weeks prior to the first dose of study medication
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- Received or plan to receive live vaccines or attenuated live vaccines within 4 weeks prior to the first dose of study medication or during the study period
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation
- Uncontrolled or significant cardiovascular or cerebrovascular disease, including (but not limited to):
- Within 6 months prior to the first dose of study medication, any of the following occurred: congestive heart failure (NYHA Class III or IV), myocardial infarction, or cerebral infarction (except for lacunar infarction), pulmonary embolism, unstable angina, or the presence of arrhythmias requiring treatment at screening; Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); A history of clinically significant QTc interval prolongation, second-degree type II atrioventricular block or third-degree atrioventricular block, or QTc interval (Fridericia's formula) > 470 msec (females) or > 450 msec (males); Atrial fibrillation (EHRA classification ≥ class 2b); Uncontrolled hypertension, as judged by the investigator to be unsuitable for participation in the study
- Presence of clinically uncontrollable third space fluid accumulation, such as large amounts of pleural effusion, pericardial effusion, or ascites that are associated with clinical symptoms or require symptomatic treatment.
- History of interstitial lung disease that requires treatment or current severe pulmonary disease, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc.
- A clear history of neurological or psychiatric disorders, either past or present, including epilepsy or dementia, etc.
- Toxicities from previous anti-cancer treatments have not yet recovered to grade 0-1 of the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0), except for alopecia, hyperpigmentation, or other conditions that the investigator deems do not increase the risk to the subject from treatment.
- Persistent grade ≥2 sensory or motor neuropathy.
- Active infections that require systemic treatment:
- Active infections requiring systemic treatment within 7 days prior to the first dose, routine antimicrobial prophylaxis is allowed; Positive HIV test results; Patients with active hepatitis B or C (HBsAg positive with detectable HBV DNA levels above the upper limit of normal; HCVAb positive with detectable HCV RNA levels above the upper limit of normal).
- Having active autoimmune diseases within the past 2 years that require systemic treatment (such as corticosteroids or immunosuppressive drugs), except for replacement therapies (such as thyroid hormone, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency).
- Having other malignant tumors within 5 years prior to signing the informed consent form (except for effectively treated non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, stage I endometrial cancer, or other tumors that are considered cured).
- Known hypersensitivity or delayed-type allergic reactions to certain components of Disitamab Vedotin, Toripalimab, RC148, or albumin-bound paclitaxone, or similar drugs.
- According to the investigator's judgment, there are serious concomitant diseases that could endanger the subject's safety or affect the subject's ability to complete the clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cance Hosoltal Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Xin Wang, 010-87787170, WXCAMS@126.com
About this study
Official title: A Randomized, Open-label, Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With RC148 Versus Albumin-bound Paclitaxone Alone or in Combination With Toripalimab in Subjects With HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer
Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Being tested
- Disitamab Vedotin, RC148, Albumin-bound Paclitaxone, Toripalimab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab VedotinDrug
Also called RC48
Disitamab Vedotin 2.0mg/kg,intravenous infusion, every 2 weeks
RC148Drug
20mg/kg, intravenous infusion, once every 2 weeks
Albumin-bound PaclitaxoneDrug
125 mg/m2,intravenous infusion, D1-8, every 3 weeks
ToripalimabDrug
Also called JS001
240mg,intravenous infusion, once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin +RC148 | Experimental | Not described Receives: Drug: Disitamab Vedotin; Drug: RC148 |
| Albumin-bound Paclitaxone OR Albumin-bound Paclitaxone +Toripalimab | Active comparator | Not described Receives: Drug: Albumin-bound Paclitaxone; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1
Measured: 24 months
Secondary outcomes (3)
PFS
Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first
Measured: From the first dose to the first documentation of disease progression or death, up to two years
DCR
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1
Measured: 24 months
OS
OS is the time from randomization to death due to any cause safety
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Feb 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642545
- Sponsor's protocol ID
- RC48-C036
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With RC148 Versus Albumin-bound Paclitaxone Alone or in Combination With Toripalimab in Subjects With HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06642545
- Acronym / sponsor ID
- RC48-C036
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin +RC148 | Experimental | Drug: Disitamab Vedotin, Drug: RC148 |
| Albumin-bound Paclitaxone OR Albumin-bound Paclitaxone +Toripalimab | Active comparator | Drug: Albumin-bound Paclitaxone, Drug: Toripalimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Voluntarily agree to participate in the study and sign the informed consent form
- Stage III unresectable locally advanced or Stage IV metastatic breast cancer.
- Subjects must be willing and able to provide a tumor tissue block and/or unstained pathology slides, with priority given to the most recent metastatic lesions that have not previously been subjected to radiotherapy. If this is not feasible or available, then a tumor tissue block (or fresh tissue sections) obtained from locally recurrent lesions should be provided. Freshly obtained tissue is preferred over archived tissue. The provided tissue will be used for biomarker testing and must be suitable for analysis of HER2 expression and PD-L1 expression
- Invasive breast tumor tissue has been confirmed as HER2 low expression by the central laboratory
- Invasive tumor tissue is negative for hormone receptors (HR), defined as immunohistochemistry (IHC) testing showing that the proportion of cells with positive nuclear staining for both ER and PgR in invasive cancer is less than 1%. For patients with weakly positive ER/PgR (1% to 10% of tumor cell nuclei positive), those who are not suitable for endocrine therapy after thorough evaluation by the investigator, and with approval from the sponsor after communication, may be included in this study
Key exclusion criteria (21 listed)
- Having previously received anti-HER2 treatment, including ADC (Antibody-Drug Conjugates).
- Having previously received immunotherapy, including anti PD-(L)1 or anti PD-(L)2 drugs, or drugs that directly target another stimulatory or co-inhibitory T-cell receptor (such as CD137, CTLA-4, OX-40) during the locally advanced or metastatic stage (except if the last administration was ≥12 months prior to recurrence or progression, using [neo]adjuvant anti PD-(L)1).
- Excluding subjects with brain metastases or leptomeningeal metastases. Subjects with treated brain metastases (surgery and/or radiotherapy) are eligible for inclusion if they meet the following criteria:
- Subjects who have received treatment for brain metastases may be considered for participation in this study if they have not experienced disease progression as determined by imaging studies within 4 weeks prior to the first dose of study treatment.
- They must have discontinued the use of corticosteroids or anticonvulsant therapy at least 14 days before the first dose of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disitamab VedotinAlso: RC48Disitamab Vedotin 2.0mg/kg,intravenous infusion, every 2 weeks | Drug | Disitamab Vedotin +RC148 |
| RC14820mg/kg, intravenous infusion, once every 2 weeks | Drug | Disitamab Vedotin +RC148 |
| Albumin-bound Paclitaxone125 mg/m2,intravenous infusion, D1-8, every 3 weeks | Drug | Albumin-bound Paclitaxone OR Albumin-bound Paclitaxone +Toripalimab |
| ToripalimabAlso: JS001240mg,intravenous infusion, once every 3 weeks | Drug | Albumin-bound Paclitaxone OR Albumin-bound Paclitaxone +Toripalimab |
Primary outcome
ORR
Time frame: 24 months
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1
3 secondary outcomes
PFS
Time frame: From the first dose to the first documentation of disease progression or death, up to two years
DCR
Time frame: 24 months
OS
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin, RC148 and Albumin-bound Paclitaxone in people with Breast Cancer, run by RemeGen Co., Ltd. at 1 site 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 20 inclusion and 21 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Xiaohong Su (010-65018841, xiaohong.su@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2025.