AzTrials
AzTrials

Ovarian CancerPhase 2NCT04828616

Study of DP303c Injection in Patients With Advanced Ovarian Cancer

A Phase 2 study testing DP303c injection in people with Ovarian Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is an open-label, multicentre, phase II study to evaluate the efficacy and safety of of DP303c injection in patients with HER2-expressing advanced ovarian cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
DP303c injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteChina
Study dates
Jul 2021to Jul 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary agreement to provide written informed consent.
  • Aged 18 to 75 years, female.
  • Histologically or cytologically confirmed epithelial ovarian cancer, carcinoma tubae, or primary peritoneal carcinoma.
  • Patients have previously received platinum-containing chemotherapy.
  • Patients must provide tissue samples that are certified as qualified by the central laboratory, and the HER2 status of the tissue samples is determined by the central laboratory:Part1: HER2 overexpressing: IHC 2+ or IHC 3+; Part2a: HER2 overexpressing: IHC 2+ or IHC 3+; Part2b: HER2 low expressing: IHC1+;
  • The Eastern Cooperative Oncology Group (ECOG) score is 0 to 2, and life expectancy ≥ 3 months.
Show all 11Show fewer
  • At least one measurable lesion at baseline per RECIST v1.1.
  • 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 patients with liver metastasis:
  • Female 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. Women of childbearing age must have a negative pregnancy test within 7 days before study entry.
  • Patients will be able to communicate well with the investigator, understand and comply with the requirements of the study.

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 that have related toxicity, resulting in permanent discontinuation.
  • Patients with allergic history or delayed allergic reaction to any components (trastuzumab analogues, MMAE, sodium citrate dihydrate, citrate monohydrate, polysorbate 20 and 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.
  • Chemotherapy, radiotherapy, biotherapy, targeted therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first dose of study drug, 6 weeks for nitrosourea (such as carmustine, lomustine, etc.) or mitomycin C, 5 half-lives for oral fluorouracil and small molecule targeted drugs, 2 weeks for endocrine therapy and Chinese medicine treatment with anti-tumor indications; or local palliative radiotherapy for bone metastasis and pain relief within 2 weeks.
Show all 26Show fewer
  • People 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 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, stage I ductal carcinoma in situ and stage I grade 1 endometrial carcinoma that have been radically removed and have not recurred; breast cancer with no recurrence for more than 3 years after radical operation).
  • History of (non-infectious) interstitial lung disease (ILD)/pulmonary disease that required steroids, or current ILD/pulmonary disease, or suspected ILD/ pulmonary disease that cannot be excluded by imaging examination; except for patients with radiation pneumonitis without clinical symptoms after 3 months of radiotherapy.
  • Patients with dyspnea at rest induced by complications of advanced malignant tumors or need for continuous oxygen therapy.
  • Patients with complete intestinal obstruction, or pleural effusions or ascites that are difficult to control within 4 weeks before entry (the frequency of percutaneous drainage is more than twice a week, or continuous drainage daily volume is ≥ 1000 mL).
  • Patients with serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • Uncontrolled angina, congestive heart failure (NYHA III-IV), myocardial infarction or severe arrhythmia 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 >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; Others (liposomal doxorubicin or other anthracyclines is equivalent to a dose of > 500 mg/m2 adriamycin); if more than one anthracycline is used, the cumulative dose is equivalent to a total dose of >500 mg/m2 adriamycin.
  • Peripheral neuropathy ≥grade 2 before entry (NCI CTCAE 5.0).
  • Uncontrollable electrolyte imbalances include hypokalemia, hypocalcemia or hypomagnesemia (refer to NCI CTCAE 5.0, ≥2 grade).
  • HIV positive, or syphilis infection requiring systematic treatment.
  • 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).
  • Patients have used strong CYP3A4 inhibitors or CYP3A4 strong inducers with a washout period less than 28 days or 5 half-lives (whichever is shorter) before the first dose of the study drug.
  • Patients underwent major surgery within 4 weeks and did not fully recover before the first dose of study drug.
  • 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.
  • Patients with any mental or cognitive impairment that may restrict their understanding and implementation of the informed consent form.
  • 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

1 site in 1 country.

China1 site

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Qi Zhou, Master, 18908384529, Qizhou9128@163.com

    Qi Zhou, Master

Other trials in China

About this study

Official title: An Open-label, Multicentre, Phase II Study of DP303c Injection in Patients With HER2-expressing Advanced Ovarian Cancer

This study is an open-label, multicentre, phase II study to evaluate the efficacy and safety of of DP303c injection in patients with HER2-expressing advanced ovarian cancer.

Read the detailed description

This is an open-label, multicenter, phase II study of DP303c injection in patients with HER2-expressing advanced ovarian cancer with two parts. In part 1, patients will be treated with DP303c injection at two dose levels (2.0 mg/kg or 3.0 mg/kg) every 3 weeks to determine the recommended phase 2 dose (RP2D). Once the RP2D has been established in part 1, patients will be enrolled into 2 cohorts in part 2.

Conditions
Ovarian Cancer
Being tested
DP303c injection
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DP303c injectionDrug

    Also called DP303c

    DP303c injection, every 3 weeks (Q3W)

Study groups in NCT04828616
Study groupRoleWhat they receive
DP303c injectionExperimentalPart1:Patients with HER2-expressing advanced ovarian cancer will be treated with DP303c injection at 2.0 mg/kg or 3.0 mg/kg every 3 weeks (Q3W) to determine the recommended phase 2 dose (RP2D). Part2a:Patients with HER2-overexpressing advanced ovarian cancer will be treated with DP303c injection at RP2D. Part2b:Patients with HER2-lowexpressing advanced ovarian cancer will be treated with DP303c injection at RP2D.
Receives: Drug: DP303c injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate(ORR)

    Objective Response Rate is defined as the percentage of patients with a complete response (CR) or partial response (PR).

    Measured: Through study completion, an average of 3 year

Secondary outcomes (8)

  1. PFS

    Progression Free Survival

    Measured: Through study completion, an average of 3 year

  2. OS

    Overall Survival

    Measured: From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months)

  3. Duration of Response (DoR)

    To preliminarily evaluate DoR in patients with advanced solid tumors

    Measured: Through study completion, an average of 3 year

  4. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    The drug safety will be assessed by investigator(s) according to NCI-CTCAE v5.0.

    Measured: Through study completion, an average of 3 year

  5. Maximum concentration (Cmax) of DP303c

    The pharmacokinetics(PK) profile of DP303c

    Measured: Part1:Cycle 1 Day 1, Cycle 1 Day 8,Cycle 1 Day 15, Cycle 2 Day 1 ,Cycle 2 Day 15,Cycle 3 Day 1and Cycle 5 Day 1;Part2:Cycle 1 Day 1, Cycle 1 Day 8,Cycle 1 Day 15, Cycle 2 Day 1 ,Cycle 2 Day 15; predose. A cycle is 21 days

  6. Time of peak plasma concentration (Tmax)

    The pharmacokinetics(PK) profile of DP303c

    Measured: Part1:Cycle 1 Day 1, Cycle 1 Day 8,Cycle 1 Day 15, Cycle 2 Day 1 ,Cycle 2 Day 15,Cycle 3 Day 1and Cycle 5 Day 1;Part2:Cycle 1 Day 1, Cycle 1 Day 8,Cycle 1 Day 15, Cycle 2 Day 1 ,Cycle 2 Day 15; predose. A cycle is 21 days

  7. Area under the plasma concentration time curve (AUC) of DP303c

    The pharmacokinetics(PK) profile of DP303c

    Measured: Part1:Cycle 1 Day 1, Cycle 1 Day 8,Cycle 1 Day 15, Cycle 2 Day 1 ,Cycle 2 Day 15,Cycle 3 Day 1and Cycle 5 Day 1;Part2:Cycle 1 Day 1, Cycle 1 Day 8,Cycle 1 Day 15, Cycle 2 Day 1 ,Cycle 2 Day 15; predose. A cycle is 21 days

  8. Immunogenicity (anti-drug antibody ADA)

    Percentage of patients producing detectable ADA.

    Measured: Through study completion, an average of 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2021
  2. Study startJul 2021 (estimated)
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

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
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04828616
Sponsor's protocol ID
SYSA1501-CSP-002
Status last verified
Mar 2021
First submitted
28 Mar 2021
Last updated
2 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DP303c injection in people with Ovarian Cancer, 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 11 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 2 Apr 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: Through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04828616.

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 2 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in