A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors

December 16, 2024 updated by: LaNova Medicines Limited

A Phase I/II, Open-label, Dose Escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of LM-101 Injection as a Single Agent or Combination Therapy in Patients With Advanced Malignant Tumors

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Terminated
        • Beijing Tongren Hospital, CMU
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Dongmei Ji
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Yi Xia
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • fuling Zhou
    • Shandong
      • Linyi, Shandong, China
        • Not yet recruiting
        • Linyi Cancer Hospital
        • Contact:
          • Jianhua Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 in the combination therapy group must have Archived Samples or fresh tumor tissue specimens are required for testing.
  8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose:
  9. 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.
  10. 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 the same target therapy.
  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. Poorly controlled tumor-related pain.
  6. Subjects with symptomatic/active central nervous system (CNS) metastases.
  7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  8. Subjects with known hypersensitivity to antibody therapy.
  9. 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.
  10. 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.
  11. Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
  12. Use of any live attenuated vaccines within 28 days prior to the first dosing of LM-101.
  13. Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
  14. Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.).
  15. Subjects who have history of severe cardiovascular disease.
  16. Subjects who have uncontrolled or severe illness.
  17. Subjects who have a history of immunodeficiency disease.
  18. HIV infection, active tuberculosis or active HBV and HCV infection.
  19. Subjects who have Known history of active tuberculosis.
  20. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.
  21. Child-bearing potential female who have positive results in pregnancy test or are lactating.
  22. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
  23. Subject who is judged as not eligible to participate in this study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LM101 Dose Escalation
Drug: LM101
Administered intravenously
Experimental: LM101 combination therapy exploratory
Drug: Rituximab
Administered intravenously
Drug: LM101
Administered intravenously
Drug: Toripalimab
Administered intravenously
Experimental: LM101 combination expansion
Drug: Rituximab
Administered intravenously
Drug: LM101
Administered intravenously
Drug: Toripalimab
Administered intravenously

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)
Time Frame: 48 weeks
Phase 1
48 weeks
Incidence of dose-limitingtoxicity (DLT)
Time Frame: 48 weeks
Phase 1
48 weeks
Incidence of serious adverse event (SAE)
Time Frame: 48 weeks
Phase 1
48 weeks
Temperature in ℃
Time Frame: 48 weeks
Phase 1
48 weeks
Pulse in BPM(Beat per Minute)
Time Frame: 48 weeks
Phase 1
48 weeks
Blood Pressure in mmHg
Time Frame: 48 weeks
Phase 1
48 weeks
Weight in Kg
Time Frame: 48 weeks
Phase 1
48 weeks
Height in centimeter
Time Frame: 48 weeks
Phase 1
48 weeks
Laboratory tests-Blood Routine examination
Time Frame: 48 weeks
Phase 1
48 weeks
Laboratory tests-Urine Routine test
Time Frame: 48 weeks
Phase 1
48 weeks
Laboratory tests-Blood biochemistry
Time Frame: 48 weeks
Phase 1
48 weeks
Laboratory tests- Coangulation function
Time Frame: 48 weeks
Phase 1
48 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Time Frame: 48 weeks
Phase 1
48 weeks
ECOG(Eastern Cooperative Oncology Group) score
Time Frame: 48 weeks
Phase 1
48 weeks
Overall Response Rate (ORR)
Time Frame: 64 weeks
Phase 2
64 weeks
12-lead electrocardiogram (ECG) in QTcF.
Time Frame: 48 weeks
Phase 1
48 weeks
12-lead electrocardiogram (ECG) in QT.
Time Frame: 48 weeks
Phase 1
48 weeks
12-lead electrocardiogram (ECG) in QRS.
Time Frame: 48 weeks
Phase 1
48 weeks
12-lead electrocardiogram (ECG) in HR.
Time Frame: 48 weeks
Phase 1
48 weeks
12-lead electrocardiogram (ECG) in RR.
Time Frame: 48 weeks
Phase 1
48 weeks
12-lead electrocardiogram (ECG) in PR.
Time Frame: 48 weeks
Phase 1
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Time Frame: 112 weeks
Phase 1 and 2
112 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Time Frame: 112 weeks
Phase 1 and 2
112 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)
Time Frame: 112 weeks
Phase 1 and 2
112 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Time Frame: 112 weeks
Phase 1 and 2
112 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Time Frame: 112 weeks
Phase 1 and 2
112 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Time Frame: 112 weeks
Phase 1 and 2
112 weeks
PK Parameter: Accumulation Ratio (Rac)
Time Frame: 48 weeks
Phase 1 and 2
48 weeks
PK Parameter: Elimination Half-life (t1/2)
Time Frame: 112 weeks
Phase 1
112 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Time Frame: 112 weeks
Phase 1 and 2
112 weeks
PK Parameter: Degree of Fluctuation (DF)
Time Frame: 112 weeks
Phase 1 and 2
112 weeks
Immunogenicity of LM-101
Time Frame: 112 weeks
Phase 1 and 2; Anti-Drug antibody and Nab (if neccessary) will be tested.
112 weeks
Receptor Occupancy of LM-101
Time Frame: 48 weeks
Phase 1
48 weeks
Biomarker correlation (CD8/CD47/CD68/CD163/PD-L1)
Time Frame: 112 weeks
Phase 1 and 2
112 weeks
Duration of Response (DOR) in Month
Time Frame: 64 weeks
Phase 2
64 weeks
Disease control rate (DCR) in percentage
Time Frame: 64 weeks
Phase 2
64 weeks
progression-free survival (PFS) in Month
Time Frame: 64 weeks
Phase 2
64 weeks
Overall survival (OS) in Month
Time Frame: 64 weeks
Phase 2
64 weeks
Changes of target lesions from baseline in Millimeter.
Time Frame: 64 weeks
Phase 2
64 weeks
Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)
Time Frame: 64 weeks
Phase 2
64 weeks
Temperature in ℃
Time Frame: 64 weeks
Phase 2
64 weeks
Pulse in BPM(Beat per Minute)
Time Frame: 64 weeks
Phase 2
64 weeks
Blood Pressure in mmHg
Time Frame: 64 weeks
Phase 2
64 weeks
Weight in Kg
Time Frame: 64 weeks
Phase 2
64 weeks
Height in centimeter
Time Frame: 64 weeks
Phase 2
64 weeks
Laboratory tests-Blood Routine examination
Time Frame: 64 weeks
Phase 2
64 weeks
Laboratory tests-Urine Routine test
Time Frame: 64 weeks
Phase 2
64 weeks
Laboratory tests-Blood biochemistry
Time Frame: 64 weeks
Phase 2
64 weeks
Laboratory tests- Coangulation function
Time Frame: 64 weeks
Phase 2
64 weeks
12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.
Time Frame: 64 weeks
Phase 2
64 weeks
ECOG(Eastern Cooperative Oncology Group) score
Time Frame: 64 weeks
Phase 2
64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LaNova Medicines Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LM101-01-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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