A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
- Summary
- This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .
- Short title
- A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Phesgo® Biosimilar HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-07-22
- First posted
- 2026-05-22
- Registry last updated
- 2026-05-22
- Primary completion date
- 2027-04-23
- Start date
- 2026-07-03
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Henlius Biotech
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07601620
- ClinicalTrials.gov ID
- NCT07601620
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Peak concentration (Cmax)
Timeframe: up to 180 days
Peak concentration after a single drug administration in Cycle 1.
Area under the serum drug concentration-time curve from 0 to 21 days (AUC0-21d)
Timeframe: up to 180 days
Area under the serum drug concentration-time curve from 0 to 21 days after a single drug administration in Cycle 1.
Steady-state peak concentration (Cmax,ss)
Timeframe: up to 180 days
The steady-state peak concentration after multiple doses administration in Cycle 4.
Steady-state area under the serum drug concentration-time curve within a dosing interval (AUCss)
Timeframe: up to 180 days
Steady-state area under the serum drug concentration-time curve within a dosing interval after multiple doses administration in Cycle 4.
Trough concentration (Ctrough)
Timeframe: up to 180 days
Trough concentration after a single dose administration
Area under the serum drug concentration-time curve from time 0 to infinity (AUC0-inf)
Timeframe: up to 180 days
Area under the serum drug concentration-time curve from time 0 to infinity after a single dose administration
Percentage of extrapolated area in the total AUC (%AUCex)
Timeframe: up to 180 days
Percentage of extrapolated area in the total AUC after a single dose administration
Time to peak concentration (Tmax)
Timeframe: up to 180 days
time to peak concentration after a single dose administration
Elimination half-life (T1/2)
Timeframe: up to 180 days
elimination half-life after a single dose administration
Total clearance (CL/F)
Timeframe: up to 180 days
total clearance after a single dose administration
Terminal phase distribution volume (Vz/F)
Timeframe: up to 180 days
terminal phase distribution volume after a single dose administration
Mean residence time (MRT)
Timeframe: up to 180 days
mean residence time after a single dose administration
Steady-state trough concentration (Ctrough,ss)
Timeframe: up to 180 days
steady-state trough concentration after multiple doses administration in Cycle 4
Average steady-state concentration (Caverage,ss)
Timeframe: up to 180 days
average steady-state concentration after multiple doses administration in Cycle 4
Steady-state time to peak concentration (Tmax,ss)
Timeframe: up to 180 days
steady-state time to peak concentration after multiple doses administration in Cycle 4
Elimination half-life (T1/2,ss)
Timeframe: up to 180 days
elimination half-life after multiple doses administration in Cycle 4
Steady-state volume of distribution (Vss/F)
Timeframe: up to 180 days
steady-state volume of distribution after multiple doses administration in Cycle 4
Steady-state total clearance (CLss/F)
Timeframe: up to 180 days
steady-state total clearance after multiple doses administration in Cycle 4
accumulation ratio based on Cmax (RCmax)
Timeframe: up to 180 days
accumulation ratio based on Cmax after multiple doses administration in Cycle 4
Accumulation ratio based on AUC (RAUC)
Timeframe: up to 180 days
accumulation ratio based on AUC after multiple doses administration in Cycle 4
The total pathological complete response (tpCR) rate assessed by the investigator
Timeframe: up to 180 days
Breast pathologic complete response (bpCR) rate assessed by the investigator
Timeframe: up to 180 days
Objective response rate (ORR) assessed by the investigator
Timeframe: up to 180 days
according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Incidence and severity of adverse events (AEs)
Timeframe: up to 180 days
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 6.0
Number of participants with abnormal vital signs
Timeframe: up to 180 days
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Number of participants with abnormal physical examination findings
Timeframe: up to 180 days
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Number of participants with abnormal Laboratory tests results
Timeframe: up to 180 days
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Number of participants with abnormal 12-lead ECG readings
Timeframe: up to 180 days
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Positivity rates of anti-drug antibodies (ADA)
Timeframe: up to 180 days
And 1 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Voluntary participation in the clinical study and signed the Informed Consent Form (ICF).
- Male or female aged ≥ 18 years old at the time of signing the ICF;
- Histologically confirmed invasive breast cancer, stage II-IIIC, Human Epidermal Growth Factor Receptor 2 (HER2) positive confirmed by central laboratory.
- Participants agree to undergo surgery while meeting the criteria for surgery after neoadjuvant therapy.
- Left ventricular ejection fraction (LVEF) at baseline ≥ 55%.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
- Adequate major organ functions.
- Women with child-bearing potential have a negative result of serum pregnancy test at screening period (within 7 days prior to the first dose) or if they are infertile, non- lactating, reproduction-age men and women following highly effective contraceptive measures until 7 months after last dose.
- Stage IV breast cancer, bilateral breast cancer, or multicentric breast cancer.
- History of other malignancy within 5 years.
- Prior systemic therapy for breast cancer treatment or radiotherapy.
- Patients with a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) who have received systemic therapy or radiotherapy to the ipsilateral breast.
- Patients who have undergone excision biopsy of the primary tumor and/or axillary lymph nodes or lymph node dissection.
- Have severe heart disease or medical conditions.
- Participants with viral hepatitis or those with autoimmune hepatitis, sclerosing cholangitis, or liver cirrhosis.
- Human Immunodeficiency Virus (HIV) infection, HIV antibody positive.
- Daily use of corticosteroid treatment is required.
- Sensitivity to any study medications or any of its ingredients or excipients.
- Participants who underwent any major surgery within 28 days prior to the first dose. Or participants who have received local radiotherapy, radiofrequency ablation, or interventional therapy within 2 weeks prior to the first dose.
- Received another interventional clinical trial therapy within 4 weeks prior to enrollment in the study, or intentionally participated in another interventional clinical trial during the entire study period.
- Severe, uncontrolled systemic diseases that may currently interfere with the therapeutic plan.
- Any other conditions which are inappropriate for the study in the opinion of the investigator.
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Breast neoplasm Primary condition