DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer

NCT06313086 | Recruiting Phase 3 DMC

• 2 other identifiers: SYSA1501-009CTR20240245
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) by BIRC

  PFS is evaluated by a Blinded Independent Review Committee (BIRC) according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.

  Up to approximately 4 years

Secondary Outcomes (5)

• Progression-free survival (PFS) by investigator

  Up to approximately 4 years

• Overall Survival (OS)

  Up to approximately 4 years

• Objective response rate (ORR)

  Up to approximately 4 years

• Duration of response (DoR)

  Up to approximately 4 years

• Incidence and severity of adverse events (AEs)

  Up to approximately 4 years

Study Arms (2)

DP303c

EXPERIMENTAL

DP303c injection, 3.0 mg/kg, Q3W.

Drug: DP303c

trastuzumab emtansine

ACTIVE COMPARATOR

trastuzumab emtansine,3.6 mg/kg, Q3W.

Drug: trastuzumab emtansine

Interventions

DP303c DRUG

intravenous injection

DP303c

trastuzumab emtansine DRUG

intravenous injection

Also known as: T -DM1

trastuzumab emtansine

Eligibility Criteria

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

You may qualify if:

• ．Voluntarily agree to participate in the study and sign the informed consent;
• ．Age≥18 years old;
• ．Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology;
• ．Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
• ．Previously received regimens containing trastuzumab and taxanes at the advanced stage of disease.
• ．The Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
• ．Patients with adequate organ functions;
• ．Life expectancy ≥ 3 months;
• ．Female and male patients of childbearing age must agree to take adequate contraceptive measures during the entire study period.

You may not qualify if:

• \. Patients who have previously received tubulin inhibitor-loaded HER2 ADC therapy
• \. History of any other malignant tumors within three years
• \. With uncontrollable serous effusion within 14 days before randomization, which required frequent drainage or medical intervention.
• \. Known contraindication to the study drugs;
• \. Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ Grade 1 or baseline (refer to NCI CTCAE 5.0);
• \. NCI-CTCAE 5.0 ≥Grade 2 peripheral nephropathy occurred during previous systemic anti-tumor treatment;
• \. Received immunotherapy, macromolecular targeted therapy or other anti-tumor biological therapy within 4 weeks before randomization, or received endocrine therapy, cytotoxic drug chemotherapy and small molecular targeted drug therapy within 2 weeks before randomization, or received traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before randomization .
• \. Major organ surgery (excluding needle biopsy) within 28 days before randomization;
• \. Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
• The cumulative amount of previous exposure to anthracyclines has reached the dosage;
• History of LVEF \< 40%, symptomatic congestive heart failure (CHF),
• Serious or uncontrolled cardiovascular disease;
• History of (non-infectious) interstitial lung disease/pneumonitis requiring steroid hormone therapy;
• Patients who currently have ocular diseases that require medication or surgical intervention; or unwilling to stop wearing contact lenses during the study.
• Active infections requiring intravenous antibiotics, antivirals, or antifungals within 14 days before randomization;

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Ado-Trastuzumab Emtansine

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 15, 2024
• Study Start: March 13, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 10, 2024

Record last verified: 2023-12

Locations

CN (1)