Gastric CancerPhase 2NCT04826107
Study of DP303c Injection in Patients With Advanced or Metastatic Gastric Cancer
A Phase 2 study testing DP303c treatment, DP303c treatment（second-line of HER2-positive） and DP303c treatment （third-line of HER2-positive） in people with Gastric Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This study is an open-label, multicenter, phase II study to evaluate the efficacy and safety of DP303c injection in patients with HER2-positive advanced or metastatic gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- DP303c treatment, DP303c treatment（second-line of HER2-positive） and DP303c treatment （third-line of HER2-positive）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Dec 2024
- 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
- Volunteer to participate in this study and sign the informed consent form.
- Age ≥18 and ≤75 years, regardless of gender.
- Unresectable locally advanced, recurrent or metastatic gastric cancer (including gastric-esophageal junction adenocarcinoma) confirmed by histopathology and/or cytology; patients have received at least the first-line platinum or taxane based treatment (Patients who have progressed or recurred during neoadjuvant/adjuvant therapy or within 6 months after completion of treatment can participate. In this case, neoadjuvant/adjuvant therapy can be counted as one previous (1st-line) therapy); for each cohort in part 2, HER2-positive patients must also include trastuzumab or trastuzumab analog in the previous 1st-line therapy.
- Part 1 Progression on or after ≥ 1st-line treatment, HER2 positive. Part 2 Cohort A: Progression on or after 1st-line treatment, HER2 positive; Cohort B: Progression on or after ≥ 2nd-line of treatment, HER2 positive; Cohort C: Progression on or after ≥ 1st-line treatment, low expression of HER2; Cohort D: Progression on or after ≥ 1st-line treatment, HER2 low expression or HER2 positive.
- HER2 positive expression is defined as IHC 3+ or IHC 2+ with ISH test positive; HER2 low expression is defined as IHC 1+ or IHC 2+ with ISH test negative.
- Eastern Cooperative Oncology Group (ECOG) score of 0-1, and life expectancy ≥ 3 months.
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- The function of major organs must meet the following criteria within 7 days before enrollment (Have not received blood transfusion, EPO, G-CSF or other medical supportive treatment within 14 days before the first dose of study drug):
- Absolute neutrophil count (ANC) ≥1.5×109 /L, Platelet ≥100×109 /L; Hemoglobin ≥90 g/L or ≥5.6 mmol/L; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Creatinine clearance rate ≥30 mL/min (Calculated by Cockcroft-Gualt formula); Total bilirubin ≤1.5×ULN, or ≤3×ULN for patients with Gilbert's syndrome or liver metastasis; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5×ULN, or ≤5×ULN for patient.
- At least one measurable lesion at baseline per RECIST v1.1.
- 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.
- 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 alopecia, pigmentation and other toxicity judged no safety risk by the investigator.
- Patients who have previously received trastuzumab or trastuzumab analogues and have related toxicity, resulting in permanent discontinuation.
- Patients with history of allergy to any components (trastuzumab analogues, MMAE, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sucrose, etc.) of DP303c.
- Patients with brain or pia mater metastasis; except for patients with central nervous system (CNS) metastases in the following conditions: untreated but asymptomatic, or progression-free status in imaging evidence for at least 4 weeks after treatment and not requiring hormone therapy for at least 4 weeks.
- Patients with pleural effusions or ascites that are difficult to control (the frequency of percutaneous drainage is more than once a week, or continuous drainage daily volume is ≥500 mL).
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- The patient had acute and chronic gastrointestinal bleeding with hematemesis or melena within 4 weeks before the first administration of study drug (except for patients with only the fecal occult blood test positive, but without visible bleeding such as melena or hematemesis).
- Patients with gastrointestinal obstruction.
- Patients with dyspnea at rest induced by complications of advanced malignant tumors or need for continuous oxygen therapy.
- History of any other malignant tumors within five years (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, local prostate cancer, cervical cancer in situ and other malignant tumors that have been radically removed and have not recurred).
- History of (non-infectious) interstitial pneumonia/pulmonary disease that requires steroid treatment, or current interstitial pneumonia/pulmonary disease, or suspected interstitial pneumonia/pulmonary disease that cannot be excluded by imaging examination; except for patients with radiation pneumonitis without clinical symptoms after 3 months of radiotherapy.
- 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.
- History of congestive heart failure, unstable angina pectoris, arrhythmia.
- Patients with the following cardiac function defects at the time of enrollment:
- New York Heart Association (NYHA) heart function classification is level III or IV;
- Uncontrolled angina, congestive heart failure or myocardial infarction within 6 months before enrollment;
- Left ventricular ejection fraction (LVEF) <50% or lower limit of normal in echocardiogram (ECHO) or multi-gate detection scan (MUGA);
- Average adjusted QT interval prolongation (male>450 ms, female>470 ms), QT interval corrected by Fridericia's formula (QTcF).
- The cumulative amount of previous exposure to anthracyclines has reached the following doses: doxorubicin or liposomal doxorubicin>500 mg/m2; epirubicin>900 mg/m2; mitoxantrone>120 mg/m2.
- Peripheral neuropathy ≥ grade 2 before entry (refer to NCI CTCAE 5.0).
- Uncontrollable electrolyte imbalances include hypokalemia, hypocalcemia or hypomagnesemia (refer to NCI CTCAE 5.0, ≥2 grade).
- Patients with active hepatitis B or C (HBsAg positive, with HBV DNA positive, and the ALT continues to be higher than the upper limit of normal, without other causes of ALT elevation; HCVAb positive with HCV RNA higher than the upper limit of normal).
- Test positive for HIV or syphilis.
- Patients have used strong CYP3A4 inhibitors (drugs that increase the AUC of specific CYP substrates ≥ 5 times, or CYP3A4 strong inducers with a washout period less than 5 half-lives before the first dose of study drug.
- Patients underwent major surgery within 4 weeks and did not fully recover before the first dose of study drug.
- Chemotherapy, radiotherapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first dose of study drug, within 2 weeks for Chinese medicine treatment with anti-tumor indications or local palliative radiotherapy for bone metastasis and pain relief; or within 5 half-lives for oral fluorouracil and small molecule targeted drugs.
- Patients have received other clinical trial drugs within 4 weeks before the first dose of study drug.
- Have previously received antibody drug conjugate targeting HER2.
- Other serious or uncontrollable diseases or conditions that may affect the evaluation of the primary endpoint or the investigator believes that participation in this study may bring risks to the patient.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-label, Multicentre, Phase II Study of DP303c Injection in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Gastric Cancer With HER2 Expression
This study is an open-label, multicenter, phase II study to evaluate the efficacy and safety of DP303c injection in patients with HER2-positive advanced or metastatic gastric cancer.
Read the detailed description
This is an open-label, multicenter, phase II study of DP303c injection in patients with HER2-positive advanced or metastatic gastric cancer with two parts. In part 1, patients will be treated with DP303c injection at three dose levels (2.0 mg/kg，2.5 mg/kg or 3.0 mg/kg) every 3 weeks to determine the recommended dose . Once the recommended dose has been established in part 1, patients will be enrolled into 4 cohorts in part 2.
- Conditions
- Gastric Cancer
- Being tested
- DP303c treatment, DP303c treatment（second-line of HER2-positive）, DP303c treatment （third-line of HER2-positive）, DP303c treatment（≥second-line of HER2 low expressing）, DP303c + PD-1/PD-L1 treatment
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP303c treatmentDrug
DP303c injection, every 3 weeks.
DP303c treatment（second-line of HER2-positive）Drug
DP303c injection, every 3 weeks.
DP303c treatment （third-line of HER2-positive）Drug
DP303c injection, every 3 weeks.
DP303c treatment（≥second-line of HER2 low expressing）Drug
DP303c injection, every 3 weeks.
DP303c + PD-1/PD-L1 treatmentDrug
DP303c injection + PD-1/PD-L1 injection, dose and frequency to be determined.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose-finding stage | Experimental | Patients with HER2-positive advanced or metastatic gastric cancer after receiving 1st-line treatment will be treated with DP303c injection at 2.0 mg/kg，2.5 mg/kg or 3.0 mg/kg every 3 weeks to determine the recommended dose. Receives: Drug: DP303c treatment |
| Part 2: Cohort A | Experimental | Patients with HER2-positive advanced or metastatic gastric cancer after receiving 1st-line treatment will be treated with DP303c injection at the recommended dose. Receives: Drug: DP303c treatment（second-line of HER2-positive） |
| Part 2: Cohort B | Experimental | Patients with HER2-positive advanced or metastatic gastric cancer after receiving ≥ 2nd-line treatment will be treated with DP303c injection at the recommended dose. Receives: Drug: DP303c treatment （third-line of HER2-positive） |
| Part 2: Cohort C | Experimental | Patients with advanced or metastatic gastric cancer with HER2 low expression after receiving ≥1st-line treatment will be treated with DP303c injection at the recommended dose. Receives: Drug: DP303c treatment（≥second-line of HER2 low expressing） |
| Part 2: Cohort D | Experimental | Patients with advanced or metastatic gastric cancer with HER2 low expression or HER2-positive expression after receiving ≥1st-line treatment will be treated with DP303c injection combined with PD-1/PD-L1 treatment. Receives: Drug: DP303c + PD-1/PD-L1 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR(Objective Response Rate)
The percentage of patients with a complete response (CR) or partial response (PR).
Measured: Up to 2.5 years
Secondary outcomes (5)
PFS(Progression Free Survival)
The time from the first dose of study treatment to the date of documented disease progression, clinical progression, or death from any cause.
Measured: Up to 2.5 years
OS(Overall Survival)
The time from the first dose of study treatment until the date of death from any cause.
Measured: Up to 2.5 years
DCR(Disease Control Rate)
Number of subjects who achieved a best response of CR, PR, or SD during treatment.
Measured: Up to 2.5 years
DOR(Duration of Response)
The time from the first objective response (CR or PR) to documented PD, clinical progression, or death from any cause.
Measured: Up to 2.5 years
AEs and SAEs
Incidence of adverse events and serious adverse events.
Measured: Up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study startAug 2021 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xu JianMing, Ph.D, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826107
- Sponsor's protocol ID
- SYSA1501-CSP-003
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All researchers can share the IPD from the EDC(the database to collecting the information of each participant ),including AEs,SAEs,ORR,PFS,OS.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicentre, Phase II Study of DP303c Injection in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Gastric Cancer With HER2 Expression
- ClinicalTrials.gov ID
- NCT04826107
- Acronym / sponsor ID
- SYSA1501-CSP-003
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Apr 2021 (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 study is an open-label, multicenter, phase II study to evaluate the efficacy and safety of DP303c injection in patients with HER2-positive advanced or metastatic gastric cancer.
Detailed description
This is an open-label, multicenter, phase II study of DP303c injection in patients with HER2-positive advanced or metastatic gastric cancer with two parts. In part 1, patients will be treated with DP303c injection at three dose levels (2.0 mg/kg，2.5 mg/kg or 3.0 mg/kg) every 3 weeks to determine the recommended dose . Once the recommended dose has been established in part 1, patients will be enrolled into 4 cohorts in part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose-finding stage | Experimental | Drug: DP303c treatmentPatients with HER2-positive advanced or metastatic gastric cancer after receiving 1st-line treatment will be treated with DP303c injection at 2.0 mg/kg，2.5 mg/kg or 3.0 mg/kg every 3 weeks to determine the recommended dose. |
| Part 2: Cohort A | Experimental | Drug: DP303c treatment（second-line of HER2-positive）Patients with HER2-positive advanced or metastatic gastric cancer after receiving 1st-line treatment will be treated with DP303c injection at the recommended dose. |
| Part 2: Cohort B | Experimental | Drug: DP303c treatment （third-line of HER2-positive）Patients with HER2-positive advanced or metastatic gastric cancer after receiving ≥ 2nd-line treatment will be treated with DP303c injection at the recommended dose. |
| Part 2: Cohort C | Experimental | Drug: DP303c treatment（≥second-line of HER2 low expressing）Patients with advanced or metastatic gastric cancer with HER2 low expression after receiving ≥1st-line treatment will be treated with DP303c injection at the recommended dose. |
| Part 2: Cohort D | Experimental | Drug: DP303c + PD-1/PD-L1 treatmentPatients with advanced or metastatic gastric cancer with HER2 low expression or HER2-positive expression after receiving ≥1st-line treatment will be treated with DP303c injection combined with PD-1/PD-L1 treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Volunteer to participate in this study and sign the informed consent form.
- Age ≥18 and ≤75 years, regardless of gender.
- Unresectable locally advanced, recurrent or metastatic gastric cancer (including gastric-esophageal junction adenocarcinoma) confirmed by histopathology and/or cytology; patients have received at least the first-line platinum or taxane based treatment (Patients who have progressed or recurred during neoadjuvant/adjuvant therapy or within 6 months after completion of treatment can participate. In this case, neoadjuvant/adjuvant therapy can be counted as one previous (1st-line) therapy); for each cohort in part 2, HER2-positive patients must also include trastuzumab or trastuzumab analog in the previous 1st-line therapy.
- Part 1 Progression on or after ≥ 1st-line treatment, HER2 positive. Part 2 Cohort A: Progression on or after 1st-line treatment, HER2 positive; Cohort B: Progression on or after ≥ 2nd-line of treatment, HER2 positive; Cohort C: Progression on or after ≥ 1st-line treatment, low expression of HER2; Cohort D: Progression on or after ≥ 1st-line treatment, HER2 low expression or HER2 positive.
- HER2 positive expression is defined as IHC 3+ or IHC 2+ with ISH test positive; HER2 low expression is defined as IHC 1+ or IHC 2+ with ISH test negative.
Key exclusion criteria (29 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 alopecia, pigmentation and other toxicity judged no safety risk by the investigator.
- Patients who have previously received trastuzumab or trastuzumab analogues and have related toxicity, resulting in permanent discontinuation.
- Patients with history of allergy to any components (trastuzumab analogues, MMAE, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sucrose, etc.) of DP303c.
- Patients with brain or pia mater metastasis; except for patients with central nervous system (CNS) metastases in the following conditions: untreated but asymptomatic, or progression-free status in imaging evidence for at least 4 weeks after treatment and not requiring hormone therapy for at least 4 weeks.
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 |
|---|---|---|
| DP303c treatmentDP303c injection, every 3 weeks. | Drug | Part 1: Dose-finding stage |
| DP303c treatment（second-line of HER2-positive）DP303c injection, every 3 weeks. | Drug | Part 2: Cohort A |
| DP303c treatment （third-line of HER2-positive）DP303c injection, every 3 weeks. | Drug | Part 2: Cohort B |
| DP303c treatment（≥second-line of HER2 low expressing）DP303c injection, every 3 weeks. | Drug | Part 2: Cohort C |
| DP303c + PD-1/PD-L1 treatmentDP303c injection + PD-1/PD-L1 injection, dose and frequency to be determined. | Drug | Part 2: Cohort D |
Primary outcome
ORR(Objective Response Rate)
Time frame: Up to 2.5 years
The percentage of patients with a complete response (CR) or partial response (PR).
5 secondary outcomes
PFS(Progression Free Survival)
Time frame: Up to 2.5 years
OS(Overall Survival)
Time frame: Up to 2.5 years
DCR(Disease Control Rate)
Time frame: Up to 2.5 years
DOR(Duration of Response)
Time frame: Up to 2.5 years
AEs and SAEs
Time frame: Up to 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Yes. All researchers can share the IPD from the EDC(the database to collecting the information of each participant ),including AEs,SAEs,ORR,PFS,OS.
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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.
Xu JianMing, Ph.D principal investigator
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DP303c treatment, DP303c treatment（second-line of HER2-positive） and DP303c treatment （third-line of HER2-positive） in people with Gastric 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 11 inclusion and 29 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 1 Apr 2021. 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?
Contact Xu JianMing, Ph.D (010-66939843, jmxu2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(Objective Response Rate) (time frame: Up to 2.5 years). 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 1 Apr 2021.