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Trial Title:
Study of LM-299 in Subjects Advanced Malignant Tumors
NCT ID:
NCT06650566
Condition:
Malignant Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LM-299
Description:
Administered intravenously
Arm group label:
LM-299 (RP2D) Dose Expansion
Arm group label:
LM-299 Dose Escalation at different dose levels
Arm group label:
LM-299 Dose Expansion LM-299 Dose Expansion
Arm group label:
LM299 (RP2D) combination expansion
Summary:
To assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) or optimal
biological dose (OBD) and the recommended phase 2 dose (RP2D) for LM-299 in subjects with
advanced solid tumours.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participant must be ≥ 18 years or the legal age of consent at the time of signing
the ICF.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
3. Life expectancy ≥ 3 months.
4. Pre-treatment archived tumour tissue (within 3 years) or on-treatment tumour biopsy
could be provided for biomarker analysis optionally.
5. Must have at least one measurable lesion according to RECIST v1.1.
6. Adequate organ and bone marrow function as defined by protocol.
7. Participants are willing to comply with contraception requirements.
8. Subjects who are able to communicate well with investigators and understand and
adhere to the requirements of this study.
Exclusion Criteria:
1. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1
of CTCAE v5.0.
2. Subjects with uncontrolled tumour-related pain.
3. Participants with clinically significant ascites that require drainage
4. Any life-threatening bleeding events that occurred within 3 months before the first
administration of the study drug.
5. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that
contains monoclonal antibody.
6. Subject who has interstitial lung disease or a history of pneumonitis.
7. Serious infection within 4 weeks prior to the first dose of the drug
8. Subjects who have a history of immunodeficiency disease.
9. Subjects with a history of other malignancies within 5 years prior to the first
administration of the study drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the first affiliated hospital of Xinxiang medical University
Address:
City:
Xinxiang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Weizheng Kou
Facility:
Name:
Liaocheng people's hospital
Address:
City:
Liaocheng
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Baozhong Wang
Facility:
Name:
Zibo municipal hospital
Address:
City:
Zibo
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Rusen Zhao
Facility:
Name:
Shanghai Dongfang Hospital (Tongji University Affiliated Dongfang Hospital)
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Junli Xue
Facility:
Name:
Shanghai GoBroad Cancer Hospital China Pharmaceutical University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Li
Start date:
October 9, 2024
Completion date:
July 2027
Lead sponsor:
Agency:
LaNova Medicines Limited
Agency class:
Industry
Source:
LaNova Medicines Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06650566
