Study of DP303c Injection in Patients With Advanced Ovarian Cancer

NCT04828616 | Unknown Phase 2

• 1 other identifier: SYSA1501-CSP-002
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

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

  Through study completion, an average of 3 year

Secondary Outcomes (8)

• PFS

  Through study completion, an average of 3 year

• OS

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

• Duration of Response (DoR)

  Through study completion, an average of 3 year

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  Through study completion, an average of 3 year

• Maximum concentration (Cmax) of DP303c

  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

Study Arms (1)

DP303c injection

EXPERIMENTAL

Part1: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.

Drug: DP303c injection

Interventions

DP303c injection DRUG

DP303c injection, every 3 weeks (Q3W)

Also known as: DP303c

DP303c injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 2, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: April 2, 2021

Record last verified: 2021-03

Locations

CN (1)