Advanced Solid Tumor Cancer
Conditions
Brief summary
This study is to evaluate the efficacy and safety of the LM-24C5 in combination with other therapies in subjects with CEACAM5-positive advanced solid tumor
Interventions
DRUGLM-24C5
Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug: Docetaxel Q3W Administered intravenously
Sponsors
LaNova Medicines Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure. 2. Aged 18-80 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. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy. 6. CEACAM5-positive subjects. 7. At least one evaluable lesion. 8. Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose. 9. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.
Exclusion criteria
1. Subjects with a history of other malignancies within 5 years prior to first dosing of LM-24C5, excluding cured squamous cell carcinoma of the skin, basal cell carcinoma, non-muscle-invasive bladder cancer, or localized low-risk prostate cancer, carcinoma in situ of the cervix/breast, and other malignancies deemed by the investigator to potentially benefit from participation in this study. 2. Subjects who have received other anti-tumor treatments before the first dosing of LM-24C5. 3. Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. 4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. 5. Present peripheral sensory or motor neuropathy ≥ grade 2. 6. Subjects with uncontrolled pain. 7. Subjects with symptomatic and untreated central nervous system metastases, and/or meningeal metastases. 8. Subjects who have uncontrollable third space effusion. 9. Previously received targeted therapy for same target. 10. . Use of any live vaccines within 28 days prior to 1st dosing of IMP. 11. Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy. 12. Subjects on anticoagulants, such as heparin and vitamin K antagonists. 13. Clinically uncontrollable persistent recurrent vomiting. 14. Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP. 15. Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of IMP. 16. Subjects who have severe cardiovascular disease. 17. Subjects who have uncontrolled or severe illness. 18. 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. 19. Subjects with a known history of autoimmune diseases. 20. Subjects who have a history of immunodeficiency disease. 21. Subjects with HIV infection, active HBV or HCV infection. 22. Child-bearing potential female who have positive results in pregnancy. test within 7 days before the first dose or are lactating. 23. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial. 24. Subject who is judged as not eligible to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 110weeks | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-tumor Activity | 110weeks | Based on RECIST v1.1, evaluated progression-free survival (PFS), duration of response (DOR), disease control rate (DCR = CR + PR + SD), and change in target lesions relative to baseline; overall survival (OS). |
| PK Parameter（AUClast） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| Immunogenicity of LM-24C5 | baseline and 110 weeks | ADA、Nab |
| Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy. | baseline and 110 weeks | Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy. |
| PK Parameter（AUCtau） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（Cmax） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（Tmax） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（T1/2） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（ss） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（Cmin） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（CLss） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（Vss） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（Rac） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（AUC） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| PK Parameter（DF） | baseline and 110 weeks | Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Rac, Cmax, DF, etc. |
Countries
China
Contacts
CONTACTMengmeng Liu
CONTACTPaul Kong
Outcome results
None listed