A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours
NCT ID: NCT06868199
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
87 participants
INTERVENTIONAL
2025-05-06
2028-02-01
Brief Summary
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For phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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LM-168 Dose Escalation
LM-168
Q3W,Intravenous Drip
LM-168 Dose Expansion
LM-168
Q3W,Intravenous Drip
LM-168 combination dose escalation
LM-168
Q3W,Intravenous Drip
Toripalimab
Q3W,Intravenous
LM-168 combination dose expansion
LM-168
Q3W,Intravenous Drip
Toripalimab
Q3W,Intravenous
Interventions
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LM-168
Q3W,Intravenous Drip
Toripalimab
Q3W,Intravenous
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥18 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. In dose escalation stage, subjects must have 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.
6. In dose expansion stage, subjects must have histological or cytological confirmation of selected advanced solid tumors.
7. Pre-treatment archived tumour tissue or on-treatment tumour biopsy could be provided for biomarker analysis optionally.
8. At least one measurable disease.
9. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
10. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
Exclusion Criteria
2. Having received prior anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with LM-168 or experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
3. Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-168.
4. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
5. Subjects with uncontrolled tumour-related pain.
6. Subjects with known central nervous system (CNS) or meningeal metastasis.
7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
8. Subjects with esophageal or gastric varices requiring immediate intervention, or those with a history of variceal bleeding.
9. Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe liver cirrhosis.
10. Tumor invasion of surrounding vital organs or a risk of developing esophagotracheal fistula or esophagopleural fistula.
11. Patients with a history of active or previously confirmed inflammatory bowel disease.
12. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
13. Subjects who previously experienced grade ≥ 3 immune-related adverse events during immunotherapy, as well as subjects who discontinued prior immunotherapy due to severe or life-threatening immune-related adverse events.
14. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-168.
15. Subjects with the known history of autoimmune disease.
16. Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced pneumonitis, idiopathic pneumonitis, interstitial lung disease, severe radiation pneumonitis or evidence of active pneumonitis on screening chest CT scan.
17. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-168.
18. Current or recent use of aspirin (\> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
19. Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for \> 2 weeks prior to the first dose of LM-168.
20. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-168 (excluding tumour biopsy, puncture, etc.).
21. Subjects who have severe cardiovascular disease.
22. Subjects who have uncontrolled or severe illness.
23. Subjects who have a history of immunodeficiency disease.
24. HIV infection, active infection including tuberculosis, HBV and HCV infection.
25. Subjects with a history of other malignancies within 5 years prior to the first administration of the study drug.
26. Child-bearing potential female who have positive results in pregnancy test or are lactating.
27. Subjects who have psychiatric illness or disorders that may preclude study compliance.
28. Subject who is judged as not eligible to participate in this study by the investigator.
18 Years
ALL
No
Sponsors
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LaNova Medicines Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Sherry Qin
Role: STUDY_DIRECTOR
LaNova Medicines Limited
Locations
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Macquarie University
Ryde, New South Wales, Australia
MUPharm Pty Limited trading as Macquarie University Hospital Parmarcy
Ryde, New South Wales, Australia
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, Australia
Bayview Health-Investigational Drug Services
Perth, Western Australia, Australia
One Clinical Reasearch
Perth, Western Australia, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LM168-01-101
Identifier Type: -
Identifier Source: org_study_id
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