A Phase I/II of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors
Advanced Solid Tumor Cancer
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 1 / Fase 2
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 90 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
For Phase I, to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors.
For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
1. Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Participants must be ≥18 years or the legal age of consent at the time of signing the ICF.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Life expectancy ≥ 3 months.
5. Adequate organ and bone marrow function as defined by protocol.
6. Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study.
Exclusion Criteria:
1. Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.
2. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.
3. Participants with uncontrolled tumour-related pain.
4. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.
5. Participants who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-364.
6. Participants who have severe cardiovascular disease.
7. Participants who have uncontrolled or severe illness.
8. Participants who have a history of immunodeficiency disease.
9. Participants with a known history of autoimmune disease.
10. Child-bearing potential female who have positive results in pregnancy test or are lactating.
11. Participants who have psychiatric illness or disorders that may preclude study compliance.
12. Participants who is judged as not eligible to participate in this study by the investigator.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
LM-364 Monotherapy
No informado en este registro.
Drug: LM-364 for injection
LM-364 Combination Therapy
No informado en este registro.
Drug: LM-364 for injection · Drug: Tislelizumab
LM-364 for injection DRUG
Q3W, Intravenous infusion
Tislelizumab DRUG
Q3W, Intravenous infusion
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Dose limiting toxicity (DLT)
Plazo: 78 Weeks
Phase I
Adverse events (AEs)
Plazo: 78 weeks
Phase I
serious adverse events (SAEs)
Plazo: 78 weeks
Phase I
Temperatures
Plazo: 78 weeks
Phase I
Pulse in BPM
Plazo: 78 weeks
Phase I
Blood Pressure in mmHg
Plazo: 78 weeks
Phase I
Weight in Kg
Plazo: 78 weeks
Phase I
Height in centimeter
Plazo: 78 weeks
Phase I
Laboratory examinations--Blood Routine examination-Complete Blood Count
Plazo: 78 weeks
Phase I
Laboratory examinations--Blood biochemistry- Electrolytes and Metabolic Parameters
Plazo: 78 weeks
Phase I
Laboratory examinations-Urine Routine test-Urinalysis
Plazo: 78 weeks
Phase I
Laboratory examinations--Coagulation function-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT)
Plazo: 78 weeks
Phase I
Laboratory examinations--Thyroid function-For the detection of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4)
Plazo: 78 weeks
Phase I
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Plazo: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in HR
Plazo: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in RR
Plazo: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in PR
Plazo: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QRS
Plazo: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QT
Plazo: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QTcF
Plazo: 78 weeks
Phase I
ECOG score-Cooperative Oncology Group score
Plazo: 78 weeks
Phase I
Objective Response Rate (ORR)
Plazo: 52 weeks
Phase II
Medidas secundarias
PK Parameter: Area Under the Concentration-time Curve(AUC)
Plazo: 130 week
Phase I/II
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Plazo: 130 weeks
Phase I/II
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Plazo: 130 weeks
Phase I/II
PK Parameter: Elimination Half-life (T1/2)
Plazo: 130 weeks
Phase I/II
PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Plazo: 130 weeks
Phase I/II
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Plazo: 130 weeks
Phase I/II
PK Parameter: Systemic Clearance at Steady State (CLss)
Plazo: 130 weeks
Phase I/II
PK Parameter: Volume of Distribution at Steady-State (Vss)
Plazo: 130 weeks
Phase I/II
PK Parameter: Accumulation Ratio (Rac)
Plazo: 130 weeks
Phase I/II
PK Parameter: Degree of Fluctuation (DF)
Plazo: 130 weeks
Phase I/II
Immunogenicity testing-Anti-drug antibody
Plazo: 130 weeks
Phase I/II
Immunogenicity testing-neutralizing antibody (Nab)
Plazo: 130 weeks
Phase I/II
Objective response rate (ORR)
Plazo: 78 weeks
Phase I
Duration of response (DOR)
Plazo: 130 weeks
Phase I/II
Disease control rate (DCR = CR + PR + SD)
Plazo: 130 weeks
Phase I/II
Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Plazo: 130 weeks
Phase I/II
Overall survival (OS)
Plazo: 130 weeks
Phase I/II
Changes of target lesions from baseline in Millimeter
Plazo: 130 weeks
Phase I/II
QTc-PK relationship -> Correlation concentrations (total antibody, free DXd) vs ΔQTcF (Fridericia's correction)
Plazo: 78 weeks
Phase I
Incidence of adverse events (AEs)
Plazo: 52 weeks
Phase II
Incidence of serious adverse events (SAEs)
Plazo: 52 weeks
Phase II
Temperature (Celsius)
Plazo: 52 weeks
Phase II
Pulse in BPM(Beat per Minute)
Plazo: 52 weeks
Phase II
Blood Pressure in mmHg
Plazo: 52 weeks
Phase II
Weight in Kg
Plazo: 52 weeks
Phase II
Height in centimeters
Plazo: 52 weeks
Phase II
Laboratory examinations--Blood Routine examination-Complete Blood Count
Plazo: 52 weeks
Phase II
Laboratory tests-Urine Routine test-Urinalysis
Plazo: 52 weeks
Phase II
Laboratory tests-Blood biochemistry- Electrolytes and Metabolic Parameters
Plazo: 52 weeks
Phase II
Laboratory tests- Coagulation function-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT)
Plazo: 52 weeks
Phase II
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Plazo: 52 weeks
Phase II
12-lead electrocardiogram (ECG) in HR
Plazo: 52 weeks
Phase II
12-lead electrocardiogram (ECG) in RR
Plazo: 52 weeks
Phase II
12-lead electrocardiogram (ECG) in PR
Plazo: 52 weeks
Phase II
12-lead electrocardiogram (ECG) in QRS
Plazo: 52 weeks
Phase II
12-lead electrocardiogram (ECG) in QT
Plazo: 52 weeks
Phase II
12-lead electrocardiogram (ECG) in QTcF
Plazo: 52 weeks
Phase II
Eastern Cooperative Oncology Group score
Plazo: 52 weeks
Phase II
Otras medidas
To explore the relationship between the biomarkers including Nectin-4 expression and the anti-tumor activity
Plazo: 130 weeks
Phase I/II
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (7)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
7 centros
Cancer Hospital Chinese Academy of Medical SciencesBeijing, Beijing Municipality, ChinaEstado desconocido
the first affiliated hospital of Henan medical UniversityXinxiang, Henan, ChinaEstado desconocido
Taihe Hospital Affiliated Hospital of Hubei University of MedicineShiyan, Hubei, ChinaEstado desconocido
Hunan cancer hospitalChangsha, Hunan, ChinaEstado desconocido
Liaocheng People's HospitalLiaocheng, Shandong, ChinaEstado desconocido
FuDan University Shanghai Cancer CenterShanghai, Shanghai Municipality, ChinaEstado desconocido
The First School of Medicine, School of Information and Engineering,The First Affliated Hospital of Wenzhou Medical UniversityWenzhou, Zhejiang, ChinaEstado desconocido
Equipo y fechas
- Patrocinador principal
- LaNova Medicines Limited
- Inicio del estudio
- 20 oct 2026 Real
- Finalización primaria
- 19 oct 2030 Estimado
- Finalización del estudio
- 19 ago 2031 Estimado
- Primera publicación
- 29 sept 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026