- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05810103
A Study of DP303c in Patients With HER2-positive Advanced Solid Tumors
April 10, 2023 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Multi-center, Single-arm, Phase І Study of DP303c in Patients With HER2-positive Advanced Solid Tumors
This is a study of DP303c in patients with HER2-positive advanced solid tumors.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a multi-center, single-arm Phase I study to evaluate the pharmacokinetic profile, safety, and initial efficacy of DP303c in patients with HER2-positive advanced solid tumors.
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 Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Information Group officer
- Phone Number: 86-0311-69085587
- Email: ctr-contact@mail.ecspc.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Zhang Jian
- Phone Number: 18017312991
- Email: syner2000@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Voluntary agreement to provide written informed consent;
- Age ≥ 18 years and older;
- Patients with advanced solid tumors confirmed by histology or cytology;
- Received at least 1 line of systemic anti-HER2 therapy or refused systemic therapy for advanced disease states;
- Confirmed to be HER2 positive by local lab;
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy ≥ 3 months;
- Adequate functions of major organs;
- 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.
Exclusion Criteria:
- Pregnant or breastfeeding women;
- 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 judged by investigators such as alopecia, laboratory tests, etc.);
- History of LVEF < 40%, symptomatic congestive heart failure (CHF), or associated toxicity leading to permanent discontinuation during previous anti-HER2 treatments;
- History of allergy or delayed allergic reaction to any component of study drug that is considered by the investigator to be more severe;
- History of interstitial pneumonia/lung disease requiring steroid treatment;
- The cumulative amount of previous exposure to anthracyclines has reached the certain dosage;
- Treated with strong CYP3A inhibitors or strong CYP3A inducers within 14 days before the first dose of study drug or the presence of concurrent diseases requiring treatment with potent inhibitors or inducers of CYP3A4 during the study treatment;
- History of severe corneal ophthalmopathy;
- Peripheral neuropathy ≥ grade 3 (refer to NCI CTCAE 5.0);
- Symptomatic and unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis;
- Serious or uncontrolled cardiovascular disease;
- Severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antimicrobial, antifungal, or antiviral therapy within 14 days prior to randomization;
- Active hepatitis B or C;
- History of immunodeficiency diseases, including human immunodeficiency virus (HIV) positive;
- Other circumstances that may interfere with the patient's participation in the study procedures or are inconsistent with the best benefit of the patient's participation or affect the study results: such as a history of severe psychosis, drug or substance abuse, any other clinically important illness or condition, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DP303c
Eligible patients will be treated with DP303c at 3.0 mg/kg every 3 weeks.
|
DP303c injection, 3.0 mg/kg, every 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Plasma Concentration [Cmax]
Time Frame: Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
|
Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
|
Area Under Curve from 0 to the last point (AUC0-last)
Time Frame: Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
|
Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
|
Area Under Curve from t 0 to the infinity (AUC0-inf)
Time Frame: Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
|
Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
|
Time to Reach Peak Serum Concentration (Tmax)
Time Frame: Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
|
Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events (AEs)
Time Frame: Up to approximately 12 months
|
Up to approximately 12 months
|
Objective Response Rate (ORR)
Time Frame: Up to approximately 12 months
|
Up to approximately 12 months
|
Duration of Response (DoR)
Time Frame: Up to approximately 12 months
|
Up to approximately 12 months
|
Disease control rate (DCR)
Time Frame: Up to approximately 12 months
|
Up to approximately 12 months
|
Incidence of anti-drug antibodies (ADA)
Time Frame: Day 1, 8, and 15 of cycle 1, and day 1 of each following cycle (each cycle is 21 days)
|
Day 1, 8, and 15 of cycle 1, and day 1 of each following cycle (each cycle is 21 days)
|
Incidence of Neutralizing antibodies (Nab)
Time Frame: Day 1, 8, and 15 of cycle 1, and day 1 of each following cycle (each cycle is 21 days)
|
Day 1, 8, and 15 of cycle 1, and day 1 of each following cycle (each cycle is 21 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2023
Primary Completion (Anticipated)
December 23, 2023
Study Completion (Anticipated)
March 23, 2024
Study Registration Dates
First Submitted
March 14, 2023
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 12, 2023
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSA1501-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HER2-positive Advanced Solid Tumors
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Chinese PLA General HospitalFudan UniversityRecruitingHER2 Positive Advanced Solid TumorsChina
-
Shanghai Pharmaceuticals Holding Co., LtdRecruitingHER2-positive Advanced Solid TumorsChina
-
Krankenhaus NordwestTerminatedHer2/Neu Positive Advanced Solid TumorsGermany
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Bliss Biopharmaceutical (Hangzhou) Co., LtdActive, not recruitingLocally Advanced/Metastatic HER2 Positive Solid TumorsChina, United States
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Bristol-Myers SquibbCompletedSolid Tumors That Overexpress HER2 (HER2 Positive)United States, Canada
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Peking UniversityRemeGen Co., Ltd.RecruitingHER2-Positive Solid TumorsChina
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Wuhan YZY Biopharma Co., Ltd.Not yet recruitingHER2-Positive Solid Tumors
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Jiangsu Alphamab Biopharmaceuticals Co., LtdPeking UniversityCompletedHER2-positive Solid TumorsChina
Clinical Trials on DP303c
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingHER2-positive Breast Cancer
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruiting
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruiting
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingHER2-positive Advanced Breast Cancer
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingHER2-positive Breast Cancer