A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
- Summary
- This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.
- Short title
- A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
- Official title
- An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of the LM-302 Combination With Other Anti-tumor Treatment in Subjects With CLDN18.2-positive Advanced Gastro-Intestinal Cancer.
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2028-07-01
- First posted
- 2023-07-06
- Registry last updated
- 2025-09-12
- Primary completion date
- 2026-07-01
- Start date
- 2023-07-27
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- LaNova Medicines Zhejiang Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05934331
- ClinicalTrials.gov ID
- NCT05934331
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
PFS
Timeframe: 112 weeks
Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
ORR
Timeframe: 112 weeks
Objective response rate (ORR)
DOR
Timeframe: 112 weeks
Duration of response (DOR)
DCR
Timeframe: 112 weeks
Disease control rate (DCR = CR + PR + SD)
OS
Timeframe: 112 weeks
Overall survival (OS)
AEs
Timeframe: 112 weeks
Incidence of adverse events
SAEs
Timeframe: 112 weeks
Incidence of serious adverse events
Temperatures
Timeframe: 112 weeks
Temperatures
Pulse in BPM
Timeframe: 112 weeks
Beat per Minute
Blood Pressure
Timeframe: 112 weeks
Blood Pressure in mmHg
Weight
Timeframe: 112 weeks
Weight in Kg
Height
Timeframe: 112 weeks
Height in centimeter
Blood Routine examination
Timeframe: 112 weeks
Laboratory tests-Blood Routine examination
Urine Routine test
Timeframe: 112 weeks
Laboratory tests-Urine Routine test
Blood biochemistry
Timeframe: 112 weeks
Laboratory tests-Blood biochemistry
Coagulation function
Timeframe: 112 weeks
Laboratory tests- Coagulation function
LVEF
Timeframe: 112 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
HR
Timeframe: 112 weeks
12-lead electrocardiogram (ECG) in HR
RR
Timeframe: 112 weeks
12-lead electrocardiogram (ECG) in RR
PR
Timeframe: 112 weeks
12-lead electrocardiogram (ECG) in PR
QRS
Timeframe: 112 weeks
12-lead electrocardiogram (ECG) in QRS
QT
Timeframe: 112 weeks
12-lead electrocardiogram (ECG) in QT
QTcF
Timeframe: 112 weeks
12-lead electrocardiogram (ECG) in QTcF
ECOG score
Timeframe: 112 weeks
Eastern Cooperative Oncology Group score
PK Parameter:Cmax
Timeframe: 112 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
PK Parameter：Tmax
Timeframe: 112 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
And 11 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
- Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Aged 18-80 years old (including boundary values) .
- Eastern Cooperative Oncology Group (ECOG) performance status of0-1.
- Life expectancy ≥ 3 months.
- Subjects with advanced gastrointestinal tumors diagnosed histologically and/or cytologically and who have failed or are intolerant to prior standard first-line therapy (imaging confirmation required)
- CLDN18.2-positive subjects.
- At least one measurable lesion.
- Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
- Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
- Subjects with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction
- Subjects have participated in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
- Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP.
- Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. (for cohorts treated with combination PD-1).
- Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- Present peripheral sensory or motor neuropathy ≥ grade 2.
- Subjects with uncontrolled pain.
- Subjects with symptomatic/active central nervous system(CNS)metastases.
- Subject who have uncontrollable third space effusion.
- Subjects with known hypersensitivity to antibody therapy.
- Subjects have treated with the same target.
- Subjects have received Strong inhibitor/strong inducer of CYP3A4 within 14 days prior to first dose.
- Use of any live vaccines within 28 days prior to 1st dosing of IMP.
- Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.
- Subjects on anticoagulants, such as heparin and vitamin K antagonists.
- Clinically uncontrollable persistent recurrent vomiting.
- Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.
- Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of IMP.
- Subjects who have other cancers, other than the one treated in this trial, within 2 years prior to screening.
- Subjects who have severe cardiovascular disease.
- Subjects who have uncontrolled or severe illness.
- Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP.
- Subjects with a known history of autoimmune diseases.
- Subjects who have a history of immunodeficiency disease.
- Subjects with HIV infection, active HBV or HCV infection.
- Child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating.
- Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
- Subject who is judged as not eligible to participate in this study by the investigator.
- Shanghai East HospitalShanghai, ChinaRecruiting