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A manufacturing tweak to a cancer drug: will it change how the body responds?

NCT ID NCT07776132

Knowledge-focused Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial compares two versions of pertuzumab, a drug used to treat certain cancers, to see if a change in how it is manufactured affects how the body absorbs and processes it. Healthy male volunteers aged 18 to 45 receive a single intravenous dose of either the original or the updated version. Researchers measure drug levels in the blood over time and check for safety and immune reactions, aiming to confirm the two versions are equivalent.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pertuzumab injection (two versions: before and after a manufacturing process change)
What this could lead to
If the two versions behave the same in the body, it could confirm that the updated manufacturing process produces a drug that is just as safe and effective, supporting its continued use.
What could go wrong
This is an early-stage trial in a small group of healthy men, so results may not reflect effects in patients. The drug can have side effects, and the study is not designed to test how well it treats any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male subjects aged ≥18 and ≤45 years; 2. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial; 3. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance. 4. Body mass index (BMI) ≥19 and ≤26 kg/m²; 5. Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%); Exclusion Criteria: 1. Clinically significant diseases including but not limited to the gastrointestinal tract, kidneys, liver, nerves, blood, endocrine system, tumors, respiratory system, immune system, mental health, and cardiovascular and cerebrovascular diseases; 2. History of allergy or hypersensitivity reactions. 3. Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization; 4. History of blood donation or blood loss (\>450mL) within 3 months prior to randomization; 5. Positive test results for Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibodies, and Human Immunodeficiency Virus (HIV) antibodies, or abnormal and clinically significant quantitative test results for syphilis spirochetes as determined by the sub investigator; 6. History of drug abuse, substance use; 7. History of alcoholism or positive alcohol test results; 8. History of long-term heavy smoking .

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Health adult subjects

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Anhui Medical University Second Affiliated Hospital

    Hefei, Anhui, 230601, China

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