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Clinical Trials/NCT06187402
NCT06187402RecruitingPhase 1

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-24C5 in Patients With Advanced Solid Tumors

LaNova Medicines Limited6 sites in 1 country49 target enrollmentStarted: December 20, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
49
Locations
6
Primary Endpoint
Ear Temperature
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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-24C5 in subjects with advanced solid tumors.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any study related procedures.
  • •Aged ≥18 years old when sign the ICF, male or female.
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
  • •Life expectancy ≥ 3 months.
  • •Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
  • •Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimum requirements.
  • •At least one measurable lesion according to RECIST v1.
  • •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.

Exclusion Criteria

  • •Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C
  • •Any prior treatments towards the investigational target.
  • •Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. the following treatments have different time limits.
  • •Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 of CTCAE v5.
  • •Subjects with uncontrolled pain.
  • •Subjects with known central nervous system (CNS) or meningeal metastasis.
  • •Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  • •Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains any monoclonal antibody.
  • •Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-24C
  • •Subjects with the known history of autoimmune disease.
  • •Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • •Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-24C
  • •Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists for presence of active thromboembolic disease.
  • •Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-24C
  • •Subjects who have severe cardiovascular disease.
  • •Subjects who have uncontrolled or severe illness, including but not limited to ongoing or active infection
  • •Subjects who have a history of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, or organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.
  • •HIV infection, active infection including tuberculosis, HBV and HCV infection, with the exception:
  • •Subjects who have other active malignancies which are likely to require the treatment.
  • •Child-bearing potential female who have positive results in pregnancy test or are lactating.
  • •Subjects who have psychiatric illness or disorders that may preclude study compliance.
  • •Subject who is judged as not eligible to participate in this study by the investigator.

Arms & Interventions

LM-24C5 Dose Escalation

Experimental

Intervention: LM-24C5 (Drug)

LM-24C5 Dose Expansion

Experimental

Intervention: LM-24C5 (Drug)

Outcomes

Primary Outcomes

Ear Temperature

Time Frame: 60 weeks

Phase 1

Pulse in BPM(Beat per Minute)

Time Frame: 60 weeks

Phase 1

Number of participants with abnormal Urinalysis test results

Time Frame: 60 weeks

Phase 1

Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure)

Time Frame: 60 weeks

Phase 1

Incidence of serious adverse event (SAE)

Time Frame: 60 weeks

Phase 1

Number of participants with abnormal Blood Biochemistry test results

Time Frame: 60 weeks

Phase 1

12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.

Time Frame: 60 weeks

Phase 1

Incidence of adverse events (AEs)

Time Frame: 60 weeks

Phase 1

Incidence of dose-limiting toxicity (DLT)

Time Frame: 60 weeks

Phase 1

Number of participants with abnormal Hematology test results

Time Frame: 60 weeks

Phase 1

Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio).

Time Frame: 60 weeks

Phase 1

Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

Time Frame: 60 weeks

Phase 1

Overall Response Rate (ORR)

Time Frame: 36 weeks

Phase 2

ECOG(Eastern Cooperative Oncology Group) score

Time Frame: 60 weeks

Phase 1

Secondary Outcomes

  • Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)(96 weeks)
  • PK Parameter: Systemic Clearance at Steady State (CLss)(96 weeks)
  • Pulse in BPM (Beat per Minute)(36 weeks)
  • PK Parameter:Time of Maximum Observed Concentration (Tmax)(96 weeks)
  • PK Parameter: Area Under the Concentration-time Curve(AUC)(96 weeks)
  • PK Parameter: Accumulation Ratio (Rac)(96 weeks)
  • PK Parameter: Elimination Half-life (t1/2)(96 weeks)
  • Changes of target lesions from baseline in Millimeter.(96 weeks)
  • Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio).(36 weeks)
  • PK Parameter: Steady State Minimum Concentration(Cmin,ss)(96 weeks)
  • Overall survival (OS) in Month(60 weeks)
  • PK Parameter: Steady State Maximum Concentration(Cmax,ss)(96 weeks)
  • Duration of Response (DOR) in Month(96 weeks)
  • Disease control rate (DCR) in percentage(96 weeks)
  • Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)(36 weeks)
  • Number of participants with abnormal Hematology test results(36 weeks)
  • Number of participants with abnormal Blood Biochemistry test results(36 weeks)
  • PK Parameter: Volume of Distribution at Steady-State (Vss)(96 weeks)
  • PK Parameter: Degree of Fluctuation (DF)(96 weeks)
  • Immunogenicity of LM-24C5(96 weeks)
  • progression-free survival (PFS) in Month(96 weeks)
  • Ear Temperature(36 weeks)
  • Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure)(36 weeks)
  • Number of participants with abnormal Urinalysis test results(36 weeks)
  • 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.(36 weeks)
  • ECOG(Eastern Cooperative Oncology Group) score(36 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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