Actively Recruiting
A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours
Led by LaNova Medicines Limited · Updated on 2025-09-12
87
Participants Needed
6
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and/or Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours. 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.
CONDITIONS
Official Title
A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and sign informed consent
- Age 18 years or older, any gender
- ECOG performance status 0-1
- Life expectancy of at least 3 months
- Histological or cytological confirmation of advanced solid tumors
- For dose escalation: recurrent or refractory tumors progressed on or intolerable to standard therapy or no available standard therapy
- For dose expansion: confirmed selected advanced solid tumors
- Optional provision of archived tumor tissue or on-treatment tumor biopsy for biomarker analysis
- At least one measurable disease
- Adequate organ and marrow function within 7 days prior to first dose
- Ability to communicate and adhere to study requirements
You will not qualify if you...
- Participation in another clinical trial within 28 days before first dose
- Prior anti-CTLA-4, immunotherapy, or immune-oncology agents within 28 days or toxicity causing permanent discontinuation
- Anti-tumor treatments within specified periods before first dose
- Unresolved adverse events from prior anti-tumor therapy greater than grade 1
- Uncontrolled tumor-related pain
- Known central nervous system or meningeal metastasis
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- Esophageal or gastric varices needing immediate intervention or history of variceal bleeding
- Hepatic encephalopathy, hepatorenal syndrome, or severe liver cirrhosis
- Tumor invasion of vital organs or risk of esophagotracheal or esophagopleural fistula
- History of active or confirmed inflammatory bowel disease
- Grade 3 or higher hypersensitivity to monoclonal antibody treatments
- Previous grade 3 or higher immune-related adverse events or severe immune-related discontinuation
- Use of systemic corticosteroids over 10 mg prednisone equivalents or immunosuppressives within 2 weeks before first dose
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, interstitial lung disease, or active pneumonitis
- Use of live attenuated vaccines within 28 days prior to first dose
- Current or recent use of high-dose aspirin or certain antiplatelet agents
- Unstable use of full-dose anticoagulants or thrombolytics for over 2 weeks before first dose
- Major surgery or interventional treatment within 28 days before first dose (except biopsy)
- Severe cardiovascular disease
- Uncontrolled or severe illness
- History of immunodeficiency
- HIV, active infections including tuberculosis, HBV, or HCV
- History of other malignancies within 5 years before first dose
- Positive pregnancy test or lactating in females of child-bearing potential
- Psychiatric illness or disorders affecting study compliance
- Investigator judgment deeming participant ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Macquarie University
Ryde, New South Wales, Australia, 2109
Actively Recruiting
2
MUPharm Pty Limited trading as Macquarie University Hospital Parmarcy
Ryde, New South Wales, Australia, 2109
Actively Recruiting
3
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, Australia
Actively Recruiting
4
Bayview Health-Investigational Drug Services
Perth, Western Australia, Australia, 6009
Actively Recruiting
5
One Clinical Reasearch
Perth, Western Australia, Australia, 6009
Actively Recruiting
6
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
Research Team
A
Alex Yuan
CONTACT
P
Paul Kong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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