Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05615974
Other study ID # LM101-01-103
Secondary ID
Status Suspended
Phase Phase 1/Phase 2
First received
Last updated
Start date January 11, 2023
Est. completion date August 2025

Study information

Verified date November 2023
Source LaNova Medicines Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors


Recruitment information / eligibility

Status Suspended
Enrollment 145
Est. completion date August 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 years old, 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, and have progressed on standard therapy. 6. At least one evaluable lesion. 7. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose: 8. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug. 9. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study. Exclusion Criteria: 1. Subject has received prior investigational therapy directed at CD47 or SIRPa. 2. Subjects has participated in any other interventional clinical trial within 21 days prior to the first dosing of LM-101. 3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-101, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc. 4. Any adverse event from prior anti-tumor therapy has not yet recovered to = grade 1 of CTCAE v5.0. 5. Subjects with symptomatic/active central nervous system (CNS) metastases. 6. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 7. Subjects with known hypersensitivity to antibody therapy. 8. Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medicationswithin 2 weeks prior to the first dosing of LM-101. 9. Subjects with the known history of autoimmune disease with the exception of subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone. 10. Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. 11. Use of any live attenuated vaccines within 28 days prior to the first dosing of LM-101. 12. Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.). 13. Subjects who have uncontrolled or severe illness. 14. Subjects who have a history of immunodeficiency disease. 15. HIV infection, active tuberculosis or active HBV and HCV infection. 16. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening. 17. Child-bearing potential female who have positive results in pregnancy test or are lactating. 18. Subject who is judged as not eligible to participate in this study by the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LM101
Administered intravenously
Toripalimab
Administered intravenously
Rituximab
Administered intravenously
Envafolimab
Administered intravenously

Locations

Country Name City State
China Beijing Tongren Hospital, CMU Beijing
China Sun Yat-sen University Cancer Center Guangzhou Guangdong
China Linyi Cancer Hospital Linyi Shandong
China Fudan University Shanghai Cancer Center Shanghai
China Zhongnan Hospital of Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
LaNova Medicines Limited

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) Phase 1 48 weeks
Primary Incidence of dose-limitingtoxicity (DLT) Phase 1 48 weeks
Primary Incidence of serious adverse event (SAE) Phase 1 48 weeks
Primary Temperature in ? Phase 1 48 weeks
Primary Pulse in BPM(Beat per Minute) Phase 1 48 weeks
Primary Blood Pressure in mmHg Phase 1 48 weeks
Primary Weight in Kg Phase 1 48 weeks
Primary Height in centimeter Phase 1 48 weeks
Primary Laboratory tests-Blood Routine examination Phase 1 48 weeks
Primary Laboratory tests-Urine Routine test Phase 1 48 weeks
Primary Laboratory tests-Blood biochemistry Phase 1 48 weeks
Primary Laboratory tests- Coangulation function Phase 1 48 weeks
Primary Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage Phase 1 48 weeks
Primary 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc. Phase 1 48 weeks
Primary ECOG(Eastern Cooperative Oncology Group) score Phase 1 48 weeks
Primary Overall Response Rate (ORR) Phase 2 64 weeks
Secondary Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) Phase 1 and 2 112 weeks
Secondary PK Parameter:Time of Maximum Observed Concentration (Tmax) Phase 1 and 2 112 weeks
Secondary PK Parameter: Area Under the Concentration-time Curve(AUC) Phase 1 and 2 112 weeks
Secondary PK Parameter: Steady State Maximum Concentration(Cmax,ss) Phase 1 and 2 112 weeks
Secondary PK Parameter: Steady State Minimum Concentration(Cmin,ss) Phase 1 and 2 112 weeks
Secondary PK Parameter: Systemic Clearance at Steady State (CLss) Phase 1 and 2 112 weeks
Secondary PK Parameter: Accumulation Ratio (Rac) Phase 1 and 2 48 weeks
Secondary PK Parameter: Elimination Half-life (t1/2) Phase 1 112 weeks
Secondary PK Parameter: Volume of Distribution at Steady-State (Vss) Phase 1 and 2 112 weeks
Secondary PK Parameter: Degree of Fluctuation (DF) Phase 1 and 2 112 weeks
Secondary Immunogenicity of LM-101 Phase 1 and 2; Anti-Drug antibody and Nab (if neccessary) will be tested. 112 weeks
Secondary Receptor Occupancy of LM-101 Phase 1 48 weeks
Secondary Biomarker correlation (CD8/CD47/CD68/CD163/PD-L1) Phase 1 and 2 112 weeks
Secondary Duration of Response (DOR) in Month Phase 2 64 weeks
Secondary Disease control rate (DCR) in percentage Phase 2 64 weeks
Secondary progression-free survival (PFS) in Month Phase 2 64 weeks
Secondary Overall survival (OS) in Month Phase 2 64 weeks
Secondary Changes of target lesions from baseline in Millimeter. Phase 2 64 weeks
Secondary Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) Phase 2 64 weeks
Secondary Temperature in ? Phase 2 64 weeks
Secondary Pulse in BPM(Beat per Minute) Phase 2 64 weeks
Secondary Blood Pressure in mmHg Phase 2 64 weeks
Secondary Weight in Kg Phase 2 64 weeks
Secondary Height in centimeter Phase 2 64 weeks
Secondary Laboratory tests-Blood Routine examination Phase 2 64 weeks
Secondary Laboratory tests-Urine Routine test Phase 2 64 weeks
Secondary Laboratory tests-Blood biochemistry Phase 2 64 weeks
Secondary Laboratory tests- Coangulation function Phase 2 64 weeks
Secondary 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc. Phase 2 64 weeks
Secondary ECOG(Eastern Cooperative Oncology Group) score Phase 2 64 weeks
See also
  Status Clinical Trial Phase
Completed NCT02041871 - Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer N/A
Completed NCT03110783 - Bioseal Dural Sealing Study BIOS-14-001 Phase 3
Recruiting NCT05516914 - A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors Phase 1/Phase 2
Completed NCT02534506 - Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors Phase 1
Recruiting NCT05714748 - Application of mRNA Immunotherapy Technology in Epstein-Barr Virus-related Refractory Malignant Tumors Phase 1
Recruiting NCT05987098 - BBPA PET/CT in Patients With Malignant Tumors N/A
Not yet recruiting NCT01092247 - The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress N/A
Recruiting NCT03160599 - Restricted Calorie Ketogenic Diet as a Treatment in Malignant Tumors N/A
Recruiting NCT04702841 - CAR - γ δ T Cells in the Treatment of Relapsed and Refractory CD7 Positive T Cell-derived Malignant Tumors Early Phase 1
Completed NCT00165100 - Dynamic Area Telethermometry (DAT) as an Imaging Modality in Patients With Cancer N/A
Completed NCT03542773 - Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET Phase 1
Completed NCT05293990 - Usefulness of Gadovist-enhanced FLAIR Imaging N/A
Completed NCT01509612 - Additive Homeopathy in Cancer Patients Phase 3
Completed NCT01678690 - An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors Phase 0
Suspended NCT06270394 - FAP PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application N/A
Completed NCT00412503 - Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents Phase 1