New drug MG2512 enters human trials for Hard-to-Treat cancers
NCT ID NCT07348653
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study is testing a new drug called MG2512 in about 116 people with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the right dose, and see how the body processes it. Researchers will also watch for any signs that the drug might shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MG2512 injection
- What this could lead to
- If successful, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 116 participants, focused on safety and dosing. It is too soon to know if MG2512 will be effective, and side effects are unknown.
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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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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 to 75 years
- 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: 1. Voluntary participation and written informed consent. 2. 18-75 years old, no gender limitation. 3. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 4. With a life expectancy ≥ 3 months. 5. Patients with recurrent or metastatic solid tumors that have been histologically or cytologically confirmed to be incurable through surgery or radical radiotherapy and chemotherapy, who have experienced disease progression after standard treatment, or have no standard treatment plan, or are not suitable for standard treatment. 6. Be able to provide fresh or archived tumour tissue. 7. At least one measurable lesion according to RECIST v1.1. 8. Adequate bone marrow reserve and organ function. 9. Contraception is required during the trial. Exclusion Criteria: 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 2. History of other malignant tumors within 5 years before the first use of the study drug. 3. Uncontrollable tumor-related pain or symptomatic hypercalcemia. 4. Having severe cardiovascular and cerebrovascular diseases. 5. Presence of bleeding symptoms with significant clinical significance within 3 months before the first use of the study drug. 6. Uncontrollable effusion within 2 weeks before the first use of the study drug. 7. Subjects with history of interstitial pneumonia or lung diseases that severely affect lung function. 8. Having a severe infection within 4 weeks before the start of study treatment. 9. History of immunodeficiency, including positive HIV test results; presence of active hepatitis B. 10. Subjects with active pulmonary tuberculosis infection within 1 year before enrollment. 11. Adverse reactions from previous antitumor treatment that have not recovered to CTCAE ≤ Grade 1. 12. Failure to meet the following requirements for previous treatment washout: receipt of anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, immunotherapy, or other non-marketed investigational drug treatments within 4 weeks before the first use of the study drug. 13. Receipt of chest radiotherapy with a dose \> 30 Gy within 24 weeks before the first use of the study drug. 14. Subjects with previous or planned allogeneic bone marrow transplantation or solid organ transplantation. 15. Subjects with known allergy to any component or excipient of the MG2512 product. 16. Subjects with other factors that may affect the study results or lead to forced premature termination of the study, as judged by the investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
RECRUITINGBeijing, Beijing Municipality, 100032, China
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Sichuan Cancer Hospital
RECRUITINGChengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors