New antibody combo shows promise for Hard-to-Treat cancers
NCT ID NCT05518045
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study tests an experimental drug called LM-108, given alone or with another immunotherapy (toripalimab), in people with advanced solid tumors that have stopped responding to standard treatments. The trial has two phases: first, finding the safest dose, then expanding to see how well it shrinks tumors. About 392 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LM-108 (an experimental antibody) and toripalimab (an immunotherapy drug)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial (Phase I/II) focused on safety and dosing, so the treatment may not prove effective. Side effects are possible, and results may not apply to all tumor types.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 392 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2022
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- 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 to 80 years
- Sex
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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 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. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 2. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy. 3. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. 4. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose. Exclusion Criteria: 1. Have received anti-CCR8 drug treatment or other clinical study drug or treatment not on the market within 28 days prior to the first dose. 2. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. 3. Subjects with uncontrolled tumor-related pain. 4. Subjects with known brain metastases. 5. Uncontrollable clinical third luminal effusion. 6. Known history of autoimmune disease. 7. Use of any live attenuated vaccines within 28 days. 8. Have severe cardiovascular disease. 9. Uncontrolled or severe illness. 10. History of immunodeficiency disease. 11. Active malignancies which are likely to require the treatment. 12. Child-bearing potential female. 13. Have psychiatric illness or disorders.
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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
-
Beijing Cancer Hospital
Beijing, 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