LM-101, an anti-SIRPα antibody, in patients with relapsed/refractory lymphoma and advanced head and neck cancer: an open-label, multicenter, phase 1 trial.
Jun Cai, Baitian Zhao, Dongmei Ji...
https://pubmed.ncbi.nlm.nih.gov/41910591Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05615974
A Phase I/II, Open-label, Dose Escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of LM-101 Injection as a Single Agent or Combination Therapy in Patients With Advanced Malignant Tumors
Led by LaNova Medicines Limited · Updated on 2024-12-19
139
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying LM-101, a drug given intravenously, to evaluate its safety, tolerability, and appropriate dosing in adults with advanced malignant tumors that have not responded to standard treatments. This phase I/II open-label trial aims to find the maximum tolerated dose or recommended phase 2 dose of LM-101 alone or combined with other therapies. The study is sponsored by LaNova Medicines Limited and includes patients with confirmed recurrent or refractory solid tumors. Participants will receive LM-101 as a single agent or combined with drugs like Toripalimab or Rituximab, also administered intravenously. The study includes dose escalation, combination therapy exploration, and expansion phases. Treatment schedules and doses will be adjusted based on patient response and safety monitoring throughout the study period. During the trial, participants will undergo regular safety assessments including vital signs, laboratory tests, electrocardiograms, and heart function scans for up to 48 weeks. Researchers will also monitor tumor response and survival outcomes for up to 64 weeks, along with detailed pharmacokinetic and immunogenicity studies for up to 112 weeks. The total participation time varies by individual and includes ongoing evaluations of treatment effects and adverse events.
CONDITIONS
Brief Title
A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Willing to participate and able to sign informed consent prior to any study procedure
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Histological or cytological confirmation of recurrent or refractory advanced solid tumors
- Tumors have progressed after standard therapy
- At least one measurable lesion
- Archived or fresh tumor tissue samples available for testing in combination therapy group
- Adequate organ and bone marrow function based on recent lab tests within 7 days before first dose
- Women of childbearing potential agree to use effective contraception before, during, and for 6 months after treatment
- Able to communicate and comply with study requirements
You will not qualify if you...
- Previously received investigational therapy targeting the same therapy as LM-101
- Participated in another interventional clinical trial within 21 days before first LM-101 dose
- Received anti-tumor treatment such as chemotherapy, radiotherapy, endocrine therapy, or immunotherapy within 21 days before first LM-101 dose
- Any unresolved adverse event from prior anti-tumor therapy above grade 1 severity
- Poorly controlled tumor-related pain
- Symptomatic or active central nervous system metastases
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Known hypersensitivity to antibody therapies
- Using systemic corticosteroids or immunosuppressive drugs within 2 weeks before first LM-101 dose
- History of autoimmune disease except stable hypothyroidism on replacement therapy
- History of interstitial lung disease or pneumonitis requiring glucocorticoid treatment
- Received live vaccines within 28 days before first LM-101 dose
- Using therapeutic anticoagulants such as heparin or vitamin K antagonists
- Major surgery or interventional treatment within 28 days before first LM-101 dose (except biopsy or puncture)
- History of severe cardiovascular disease
- Uncontrolled or severe illnesses
- History of immunodeficiency disorders
- Active infections including HIV, tuberculosis, hepatitis B or C
- Other active invasive cancers within 5 years except the one treated in this study
- Positive pregnancy test or currently breastfeeding
- Psychiatric disorders affecting compliance
- Judged ineligible by investigator for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 48 weeks
Participants receive LM-101 injection, alone or in combination with other drugs, administered intravenously to evaluate safety and preliminary efficacy.
Regular visits for drug administration and safety monitoring
Follow-up
Duration - Up to 64 weeks
Participants are monitored for long-term safety, pharmacokinetics, immunogenicity, and efficacy outcomes after treatment.
Periodic visits for assessments and laboratory tests
Trial Site Locations
Total: 5 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
2
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
3
Linyi Cancer Hospital
Linyi, Shandong, China
Not Yet Recruiting
4
Beijing Tongren Hospital, CMU
Beijing, China
Terminated
5
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
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Research Team
A
Alex Yuan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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