HER2-positive Advanced Solid TumorsPhase 1NCT05810103
A Study of DP303c in Patients With HER2-positive Advanced Solid Tumors
A Phase 1 study testing DP303c in people with HER2-positive Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a study of DP303c in patients with HER2-positive advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Advanced Solid Tumors
- 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
- 12 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2023to 23 Mar 2024
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhang Jian, 18017312991, syner2000@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- HER2-positive Advanced Solid Tumors
- Being tested
- DP303c
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP303cDrug
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.
Maximum Plasma Concentration [Cmax]
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 outcomes (6)
Incidence of adverse events (AEs)
Measured: Up to approximately 12 months
Objective Response Rate (ORR)
Measured: Up to approximately 12 months
Duration of Response (DoR)
Measured: Up to approximately 12 months
Disease control rate (DCR)
Measured: Up to approximately 12 months
Incidence of anti-drug antibodies (ADA)
Measured: 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)
Measured: Day 1, 8, and 15 of cycle 1, and day 1 of each following cycle (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start6 Apr 2023
- Primary completion23 Dec 2023 (estimated)
- Study completion23 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Advanced Solid TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT05810103
- Sponsor's protocol ID
- SYSA1501-008
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-arm, Phase І Study of DP303c in Patients With HER2-positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05810103
- Acronym / sponsor ID
- SYSA1501-008
- Conditions
- HER2-positive Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 23 Dec 2023 (estimated)
- Study completion
- 23 Mar 2024 (estimated)
- First posted
- 12 Apr 2023 (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 solid tumors.
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 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
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 |
|---|---|---|
| DP303cDP303c injection, 3.0 mg/kg, every 3 weeks. | Drug | DP303c |
Primary outcome
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)
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)
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)
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)
6 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to approximately 12 months
Objective Response Rate (ORR)
Time frame: Up to approximately 12 months
Duration of Response (DoR)
Time frame: Up to approximately 12 months
Disease control rate (DCR)
Time frame: 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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DP303c in people with HER2-positive Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology 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 9 inclusion and 15 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 12 Apr 2023. 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 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.
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?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. 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 12 Apr 2023.