New drug combo trial hopes to tackle advanced cancers
NCT ID NCT06682780
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study is testing an experimental drug called LM-2417, given alone or with other cancer drugs, in people with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety, find the best dose, and see early signs of tumor shrinkage. About 320 participants will be enrolled across multiple sites.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LM-2417 (an experimental drug given by IV)
- What this could lead to
- If successful, this could lead to a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial (phase I/II) with a small number of participants, so the drug may not prove effective or may have unexpected side effects. The combination treatments also add complexity and risk.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2029
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 80 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. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure. 2. Aged 18-80 years old (including boundary values) , male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Life expectancy ≥ 3 months. 5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy. 6. Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing. 7. At least one evaluable lesion. 8. Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose. 9. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug. 10. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study. Single-agent dose of 6mg/kg, 12mg/kg and and combined cohort:Subjects tested positive for biomarkers. Exclusion Criteria: 1. Previously received with same target therapy. 2. Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417. 3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc. 4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. 5. Poorly controlled tumor-related pain. 6. Subjects with symptomatic/active central nervous system (CNS)metastases. 7. Subject who have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 8. Subjects with known hypersensitivity to antibody therapy; 9. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) for more than 7 days or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-2417. 10. Previous or current known autoimmune disease. 11. Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. 12. Use of any live vaccine or live attenuated vaccines within 28 days prior to the first dosing of LM-2417.; 13. Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists. 14. Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of LM-2417. 15. Subject who have history of severe cardiovascular disease. 16. Subjects who have uncontrolled or severe illness. 17. HIV infection, active HBV or HCV infection. 18. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening. 19. Child-bearing potential female who have positive results in pregnancy test or are lactating. 20. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial. 21. Subject who is judged as not eligible to participate in this study 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
1 site. 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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FuDan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 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
- Can a radioactive 'Smart Bomb' target tough tumors?
- Can a new pill shrink advanced solid tumors?
- Can a Tumor-Directed injection shrink Hard-to-Treat cancers?
- Can a new gemcitabine formulation outsmart advanced solid tumors?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?