Recruiting nowPhase 1
What this trial is trying to do
Researchers are testing MGC030, an experimental treatment, in people with advanced solid tumours to learn how the body handles it, what side effects it causes, and whether it can make tumours shrink or keep them from growing. The trial does not state how MGC030 acts on cancer cells or the immune system.
The idea is that MGC030 might control advanced cancer, measured by tumour shrinkage, stability, or delayed progression, but this trial is mainly assessing safety and tolerability rather than comparing it with standard treatment. There is no comparison group, so it cannot establish whether it helps people live longer or keeps cancer controlled for longer than existing care.
Worth knowing: This is a non-randomised phase 1 trial, so its main purpose is finding a safe dose and characterising side effects, not proving benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07822399 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 314 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | MacroGenics |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological MGC030
What it is measuring
Number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to dose interruption, AEs leading to dose reduction or treatment discontinuation, does limiting toxicities and AEs of special interest.
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of MGC030. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors of select types.
The main question the study aims to answer is:
* What types of side effects will participants experience when receiving MGC030?
* Can MGC030 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors? Participants will
* Undergo screening procedures to determine eligibility
* Receive study treatments initially every 3 weeks.
* Have blood samples taken for routine and research tests
* Have other examinations to check heart and lung function, and general health status
* Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary.
* Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Participants in dose escalation cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: urothelial cancer, colorectal cancer (CRC), gastric or gastroesophageal junction (GEJ) cancer, esophageal cancer, or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.
- Participants in expansion cohorts must have histologically proven, unresectable, locally advanced or metastatic solid tumors
- Urothelial cancer with progression following platinum-containing chemotherapy for metastatic or locally advanced/unresectable cancer, or within 12 months from completion of neo-adjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive cancer.
- Gastric/GEJ carcinoma with progression during or following at least 1 systemic therapy.
- Esophageal cancer with progression during or following at least 1 systemic therapy.
- CRC with progression during or following treatment with at least 2 prior lines of systemic therapy (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease.
- CRC harboring an activating EGFR mutation must have progressed during or following at least one EGFR targeted therapy, if available.…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07822399, registered by MacroGenics on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.