HER2-positive Breast CancerPhase 2NCT05334810
DP303c in Patients With HER2-positive Unresectable Locally Advanced, Relapsed, or Metastaticbreast Cancer
A Phase 2 study testing DP303c in people with HER2-positive Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This is a study of DP303c in patients with HER2-positive advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- DP303c
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary agreement to provide written informed consent;
- Aged 18 to 75 years, male or female;
- Patients with unresectable locally advanced, relapsed, or metastatic breast cancer confirmed by histology or cytology;
- Received at least 2 lines of systemic anti-HER2 therapy for unresectable locally advanced, recurrent, or metastatic disease, and one of which is a trastuzumab-containing regimen, progression during or within 12 months of the end of prior (neo)adjuvant anti-HER2 therapy is considered one line of therapy.
- Radiographic evidence of disease progression confirmed by the investigator during or after the most recent systemic treatment;
- Sufficient tumor samples within 3 years are available for central lab to confirm the HER2 status;
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- Confirmed to be HER2 positive by central lab (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
- At least one measurable target lesion at the baseline according to the RECIST v1.1;
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Left ventricular ejection fraction (LVEF) ≥50% of normal in echocardiogram (ECHO) or multi-gate detection scan (MUGA) within 4 weeks before the first administration of study drug;
- The function of major organs must meet the following criteria within 7 days before enrollment (have not received blood transfusion, G-CSF, other hematopoietic stimulating factors or medical supportive treatments within 14 days before the first dose of study drug): absolute neutrophil count (ANC) ≥1.5×10^9 /L; platelet (PLT) ≥100×10^9 /L; hemoglobin ≥90 g/L; international normalized ratio (INR) or prothrombin time (PT) ≤1.5×the upper limit of normal (ULN) (not receiving anticoagulation), or patients receiving anticoagulation need to be within treatment target range and at a stable dose; activated partial thromboplastin time (APTT) ≤1.5×ULN; creatinine clearance rate>60 mL/min (calculated by Cockcroft-Gualt formula); total bilirubin ≤1.5×ULN, or ≤3×ULN for patients with Gilbert's syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, or ≤5×ULN for patient with liver metastasis;
- Life expectancy ≥ 3 months;
- Women of childbearing age must have a negative pregnancy test prior to study entry;
- Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period and through at least 6 months after the last dose of study drug.
Who cannot join
- Pregnant or breastfeeding women；
- History of DP303c treatment;
- History of any other malignant tumors within five years (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ and other in situ tumors that have received radical resection and have not recurred);
- Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCI CTCAE 5.0) (except for adverse reaction such as alopecia, pigmentation disorder and others which have no safety risk evaluated by the investigator);
- Patients have received other clinical trial drugs within 4 weeks before the first dose of study drug (for small molecule targeted drugs, this time interval is required to be 2 weeks or 5 half-lives, whichever is longer);
- Cytotoxic chemotherapy, radiotherapy and immunotherapy and other anti-tumor treatments within 4 weeks before the first dose of study drug; endocrine therapy and Chinese medicine treatments with anti-tumor indications within 2 weeks; or oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 half-lives, whichever is longer;
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- Radical radiation therapy within 4 weeks before the first dose of study drug or palliative radiation therapy within 2 weeks before the first dose of study drug;
- Underwent major surgery within 4 weeks and did not fully recover before the first dose of study drug;
- The cumulative amount of previous exposure to anthracyclines has reached the following dosage: doxorubicin or liposomal doxorubicin >360 mg/m^2; epirubicin >720 mg/m^2; mitoxantrone>120 mg/m^2; idarubicin >90 mg/m^2; or other anthracyclines > 360 mg/m^2 of doxorubicin equivalent;
- Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
- History of LVEF < 40%, symptomatic congestive heart failure (CHF), or associated toxicity leading to permanent discontinuation during previous treatments of trastuzumab or a drug containing a trastuzumab-like structure.
- Serious or uncontrolled cardiovascular disease;
- Serious or uncontrolled lung disease;
- Symptomatic ascites or pleural effusion; patients who are clinically stable for at least 1 week after local treatment (including therapeutic pleural or abdominal puncture) are admitted;
- Patients who currently have corneal diseases that require medication or surgical intervention, or have a history of serious corneal diseases, or are unwilling to stop wearing contact lenses during the study;
- Peripheral neuropathy ≥ grade 2 (refer to NCI CTCAE 5.0) or history of ≥ grade 3 neurotoxicity (refer to NCI CTCAE 5.0);
- Uncontrollable electrolyte imbalances include hypokalemia, hypocalcemia or hypomagnesemia (refer to NCI CTCAE 5.0, ≥2 grade);
- Active infections requiring intravenous antibiotics, antivirals, or antifungals within 2 weeks before the first dose of study drug;
- Active hepatitis B or C (HBsAg positive with HBV DNA >ULN, but patients with HBV DNA titer < 500 IU/mL after anti-HBV treatment could be enrolled; HCVAb positive with HCV RNA> ULN).
- History of immunodeficiency diseases, including human immunodeficiency virus (HIV) positive;
- Conditions requiring treatments with systemic corticosteroids or other immunosuppressive drugs within 2 weeks before the first dose of study drug, except for topical, ocular, intra-articular, intranasal, or inhaled corticosteroid therapy;
- History of allergy to any components of study drug;
- History of serious hypersensitivity to other monoclonal antibodies;
- Suffering from a known mental illness, severe mental illness or poor compliance;
- Treated with strong CYP3A inhibitors or strong CYP3A inducers within 14 days before the first dose of study drug;
- Any disorders, treatments, or abnormalities in laboratory tests that may affect the overall treatments of patients in the study, increase the risk of patients, or interfere with the study results; or the investigator believes that participation in the study is not in the patient's best interest.
About this study
Official title: A Multi-center, Open-lable, Single-arm Phase II Study to Evaluate the Efficacy and Safety of DP303c in Patients With HER2-positive Unresectable Locally Advanced, Relapsed, or Metastatic Breast Cancer
This is a study of DP303c in patients with HER2-positive advanced breast cancer.
Read the detailed description
This is a multi-center, open-lable, single-arm Phase II study to evaluate the efficacy and safety of DP303c in patients with HER2-positive unresectable locally advanced, relapsed, or metastatic breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg every 3 weeks. Patients will receive DP303c until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- DP303c
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP303cDrug
Also called DP303c treatment
DP303c injection, 3.0 mg/kg, every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DP303c | Experimental | Eligible patients will be treated with DP303c at 3.0 mg/kg every 3 weeks. Receives: Drug: DP303c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is assessed by the Independent Review Committee (IRC) according to the Regulated Efficacy Criteria for Solid Tumors (RECIST) V1.1
Measured: Baseline and every 6 weeks
Secondary outcomes (2)
DOR
Duration of Response
Measured: Baseline and every 6 weeks
PFS
Progression Free Survival
Measured: Baseline and every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334810
- Sponsor's protocol ID
- SYSA1501-CSP-005
- Status last verified
- Apr 2022
- First submitted
- 27 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-lable, Single-arm Phase II Study to Evaluate the Efficacy and Safety of DP303c in Patients With HER2-positive Unresectable Locally Advanced, Relapsed, or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05334810
- Acronym / sponsor ID
- SYSA1501-CSP-005
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Apr 2022 (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.
This is a study of DP303c in patients with HER2-positive advanced breast cancer.
Detailed description
This is a multi-center, open-lable, single-arm Phase II study to evaluate the efficacy and safety of DP303c in patients with HER2-positive unresectable locally advanced, relapsed, or metastatic breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg every 3 weeks. Patients will receive DP303c until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DP303c | Experimental | Drug: DP303cEligible patients will be treated with DP303c at 3.0 mg/kg every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntary agreement to provide written informed consent;
- Aged 18 to 75 years, male or female;
- Patients with unresectable locally advanced, relapsed, or metastatic breast cancer confirmed by histology or cytology;
- Received at least 2 lines of systemic anti-HER2 therapy for unresectable locally advanced, recurrent, or metastatic disease, and one of which is a trastuzumab-containing regimen, progression during or within 12 months of the end of prior (neo)adjuvant anti-HER2 therapy is considered one line of therapy.
- Radiographic evidence of disease progression confirmed by the investigator during or after the most recent systemic treatment;
Key exclusion criteria (26 listed)
- Pregnant or breastfeeding women；
- History of DP303c treatment;
- History of any other malignant tumors within five years (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ and other in situ tumors that have received radical resection and have not recurred);
- Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCI CTCAE 5.0) (except for adverse reaction such as alopecia, pigmentation disorder and others which have no safety risk evaluated by the investigator);
- Patients have received other clinical trial drugs within 4 weeks before the first dose of study drug (for small molecule targeted drugs, this time interval is required to be 2 weeks or 5 half-lives, whichever is longer);
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 |
|---|---|---|
| DP303cAlso: DP303c treatmentDP303c injection, 3.0 mg/kg, every 3 weeks. | Drug | DP303c |
Primary outcome
Objective Response Rate (ORR)
Time frame: Baseline and every 6 weeks
ORR is assessed by the Independent Review Committee (IRC) according to the Regulated Efficacy Criteria for Solid Tumors (RECIST) V1.1
2 secondary outcomes
DOR
Time frame: Baseline and every 6 weeks
PFS
Time frame: Baseline and every 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No. Undecided.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DP303c in people with HER2-positive Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 14 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Objective Response Rate (ORR) (time frame: Baseline and every 6 weeks). 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 19 Apr 2022.