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Study of DP303c Injection in Patients With Advanced Ovarian Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Study of DP303c Injection in Patients With Advanced Ovarian Cancer

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

NCT04828616•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

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.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Voluntary agreement to provide written informed consent.
•2. Aged 18 to 75 years, female.
•3. Histologically or cytologically confirmed epithelial ovarian cancer, carcinoma tubae, or primary peritoneal carcinoma.
•4. Patients have previously received platinum-containing chemotherapy.
•5. 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+;
•6. The Eastern Cooperative Oncology Group (ECOG) score is 0 to 2, and life expectancy ≥ 3 months.
•7. At least one measurable lesion at baseline per RECIST v1.1.
•8. 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:
•9. 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.
+1 more criteria

Exclusion Criteria

•1. Pregnant or breastfeeding women.
•2. 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 .
•3. Patients who have previously received trastuzumab or trastuzumab analogues that have related toxicity, resulting in permanent discontinuation.
•4. 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.
•5. 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.
•6. 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.
•7. 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.
•8. 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).
•9. 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.
•10. Patients with dyspnea at rest induced by complications of advanced malignant tumors or need for continuous oxygen therapy.
+16 more criteria

Locations (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

July 1, 2021

Primary Completion Date

July 1, 2023

Completion Date

July 1, 2024

Last Updated

April 2, 2021

Enrollment

104

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

DP303c injection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of DP303c Injection in Patients With Advanced Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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