Can an experimental drug shrink advanced solid tumors?

NCT ID NCT04868344

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This phase 1 trial tests an experimental drug called MRG003 in people with advanced solid tumors, including colorectal cancer, head and neck squamous cell carcinoma, and nasopharyngeal carcinoma. The study aims to find a safe dose and to see whether the drug can shrink tumors. Participants receive MRG003 by intravenous infusion, and researchers monitor side effects, drug levels in the blood, and tumor response.

What this could mean

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

Active substance
MRG003, an experimental drug given by intravenous infusion
What this could lead to
If MRG003 proves safe and effective, it could offer a new treatment option for people with advanced solid tumors like colorectal, head and neck, and nasopharyngeal cancers.
What could go wrong
This is an early-phase trial with a small number of participants. The drug may not shrink tumors or may cause side effects, and more research will be needed before it could become a standard treatment.

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

61 people

The number who actually took part.

Started

May 2018

Finished

Mar 2021

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Willing to sign the ICF and follow the requirements specified in the protocol. * Age: ≥18 years and ≤75 years, both genders * Expected survival time≥12 weeks * Phase Ia: Patients with histologically and cytologically confirmed advanced or metastatic solid tumor * Phase Ib: Patients with histologically and cytologically confirmed EGFR-positive advanced or metastatic colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma * Subjects must have measurable lesions according to the response Evaluation Criteria In Solid Tumors(RECIST v1.1) * ECOG performance score 0 or 1 * Acceptable liver, renal, and hematologic function * Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment Exclusion Criteria: * History of hypersensitivity to any component of the investigational product * Presence of central nervous system metastasis * Prior history of other primary malignancies * Known history of clinically significant hepatic diseases * Evidence of active infection of human immunodeficiency virus (HIV) * History of ophthalmic abnormalities * Any severe or uncontrolled systemic disease judged by the investigator * Patients with poorly controlled heart diseases * Received radiotherapy, chemotherapy, biotherapy, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment * Major surgery or surgical therapy for any cause within 4 weeks prior to the first dose of investigational drug * Planned surgery or surgery is the best interest of patients as determined by investigator * History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy * Active concomitant diseases that might increase risks of toxicity * Pregnancy, or breast feeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

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