Disitamab Vedotin(RC48) Combined With Penpulimab(AK105) for Neoadjuvant Treatment of HER2-low Breast Cancer

NCT05726175 | Unknown Phase 2

• 1 other identifier: RCVDBCIIR005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of Disitamab Vedotin combined with Penpulimab as neoadjuvant therapy in patients with HER2-low early or locally advanced breast cancer

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR) (ypT0/is N0)

  No microscopically detectable remnants of aggressive tumors in breast and axillary lymph nodes, ductal carcinoma in situ is allowed.

  Immediately after surgery

Secondary Outcomes (4)

• Objective response rate (ORR)

  Baseline (Before surgery)

• Disease Control Rate (DCR)

  Baseline (Before surgery)

• Complete remission rate of breast pathology (bpCR)

  Immediately after surgery

• Adverse events (AEs)

  From screening phase through study completion, an average of 1 year

Study Arms (1)

RC48 and AK105

EXPERIMENTAL

Disitamab Vedotin(RC48) combined with Penpulimab(AK105) as neoadjuvant therapy

Drug: Disitamab Vedotin; Drug: Penpulimab

Interventions

Disitamab Vedotin DRUG

Disitamab Vedotin(RC48)：2.0mg/kg, iv, day1, q3weeks, 6 cycles in total;

Also known as: RC48

RC48 and AK105

Penpulimab DRUG

Penpulimab(AK105)：200mg, iv, day1, q3weeks, 6 cycles in total;

Also known as: AK105

RC48 and AK105

Eligibility Criteria

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

You may qualify if:

• Female patients aged 18 to 70 years who were newly treated;
• ECOG systemic state 0\~1;
• The predicted survival time was no less than 3 months
• According to the RECIST 1.1 , at least one measurable lesion exists;
• Patients with HER2-low breast cancer confirmed by pathological examination, clinical stage II-III \[cT1N1,cT2 and any N, cT3 and any N; cT4 and any N, according to American Joint Committee on Cancer (AJCC) standards\];
• The functional level of organs must meet the following requirements: (1) Blood routine: 1) ANC \>= 1.5x10\^9/L; 2) PLT \>= 90x10\^9/L; 3) Hb \>= 90 g/L; (2) Blood biochemistry: 1) TBIL \<= 1.5 ULN; 2) ALT and AST \<= 2 ULN; 3) BUN and Cr 1.5 ULN and creatinine clearance 50 mL/min (Cockcroft-Gault formula); (3) Heart color Doppler ultrasound: LVEF \>= 50%; (4) 12-lead ECG: Fridericia corrected QT interval (QTcF) female \< 470 ms.
• Known the hormone receptor status;
• Tissue samples were available for biomarker testing
• The serum pregnancy test is negative and patients with reproductive potential must agree to use effective non-hormonal contraceptive methods during treatment and at least 6 months after the last use of the test drug;
• Volunteer to join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up.

You may not qualify if:

• Patients with inflammatory breast cancer.
• Patients with metastatic breast cancer (stage IV)
• Received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, surgical treatment (major surgery for breast cancer), endocrine therapy or molecular targeted therapy, immunotherapy, biological therapy, etc.
• Participated in other drug clinical trials within 4 weeks before enrollment.
• Have received a live vaccine within 4 weeks before the start of the study dose or plan to receive any vaccine during the study;
• Previous or current use of HER2-targeted monoclonal antibodies (trastuzumab, pertuzumab, etc.), tyrosine kinase inhibitors (lapatinib, pyrrootinib, lenatinib, etc.), ADC drugs (RC48, T-DM1, DS8201a, etc.).
• Prior treatment with anti-PD-1, PD-L1, or PD-L2 or another agent that acts directly on a T-cell surface inhibitory receptor (e.g., CTLA-4, OX-40, CD137).
• Other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma.
• Concomitant receipt of any other antineoplastic therapy.
• Presence of third-space effusion (including massive pleural effusion or ascites) that cannot be controlled by drainage or other methods.
• Known hypersensitivity or delayed hypersensitivity reactions to the drugs of this regimen, its components or similar drugs;
• Have an active autoimmune disease requiring systemic treatment (e.g., disease modulating medication, corticosteroids, or immunosuppressive medication) in the past 2 years;
• Receiving systemic steroid therapy (at a daily dose of more than 10 mg prednisone equivalent) or any form of immunosuppressive therapy within 7 days before the diagnosis of immunodeficiency or the first dose of study treatment;
• Known history of active pulmonary tuberculosis (tuberculosis, Mycobacterium tuberculosis);
• Have a history of immunodeficiency, including testing positive for HIV, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Chengdu, Sichuan, China, 610041, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

disitamab vedotin; penpulimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ting Luo, post-doctor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Luo, post-doctor

CONTACT

18602866299; tina621@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 13, 2023
• Study Start: March 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)