Can an experimental drug shrink advanced solid tumors?
NCT ID NCT04868344
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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61 people
The number who actually took part.
- Started
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May 2018
- Finished
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Mar 2021
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- Ivosidenib plus mFOLFOXIRI and celecoxib as a treatment for BRAF-targeted therapy-refractory BRAF V600E-mutant colorectal cancer patients: a phase II study
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