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Malignant TumorsPhase 1/2NCT05615974

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

A Phase 1/2 study testing LM101, Toripalimab and Rituximab in people with Malignant Tumors, run by LaNova Medicines Limited at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Tumors
What is being tested?
LM101, Toripalimab and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
5 sitesChina
Study dates
11 Jan 2023to 11 Jan 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
  • Aged ≥18 years old, male or female.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy ≥ 3 months.
  • Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy.
  • At least one evaluable lesion.
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  • Subjects in the combination therapy group must have Archived Samples or fresh tumor tissue specimens are required for testing.
  • Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose:
  • 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.
  • Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.

Who cannot join

  • Subject has received prior investigational therapy directed at the same target therapy.
  • Subjects has participated in any other interventional clinical trial within 21 days prior to the first dosing of LM-101.
  • Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-101, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.
  • Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
  • Poorly controlled tumor-related pain.
  • Subjects with symptomatic/active central nervous system (CNS) metastases.
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  • Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  • Subjects with known hypersensitivity to antibody therapy.
  • 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.
  • 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.
  • Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
  • Use of any live attenuated vaccines within 28 days prior to the first dosing of LM-101.
  • Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
  • Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.).
  • Subjects who have history of severe cardiovascular disease.
  • Subjects who have uncontrolled or severe illness.
  • Subjects who have a history of immunodeficiency disease.
  • HIV infection, active tuberculosis or active HBV and HCV infection.
  • Subjects who have Known history of active tuberculosis.
  • Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.
  • Child-bearing potential female who have positive results in pregnancy test or are lactating.
  • Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
  • Subject who is judged as not eligible to participate in this study by the investigator.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alex Yuan contact

+8615901815211

alexyuan@lanovamed.com

5 sites in 1 country

China5 sites, 4 recruiting

  • Beijing Tongren Hospital, CMU

    Beijing

    Terminated

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Yi Xia

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong

    Jianhua Shi

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Dongmei Ji

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    Fuling Zhou

    Recruiting

Other trials in China

About this study

Official title: 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

Being tested
LM101, Toripalimab, Rituximab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LM101Drug

    Administered intravenously

  • ToripalimabDrug

    Administered intravenously

  • RituximabDrug

    Administered intravenously

Study groups in NCT05615974
Study groupRoleWhat they receive
LM101 Dose EscalationExperimentalNot described
Receives: Drug: LM101
LM101 combination therapy exploratoryExperimentalNot described
Receives: Drug: LM101; Drug: Toripalimab; Drug: Rituximab
LM101 combination expansionExperimentalNot described
Receives: Drug: LM101; Drug: Toripalimab; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Phase 1

    Measured: 48 weeks

  2. Incidence of dose-limitingtoxicity (DLT)

    Phase 1

    Measured: 48 weeks

  3. Incidence of serious adverse event (SAE)

    Phase 1

    Measured: 48 weeks

  4. Temperature in ℃

    Phase 1

    Measured: 48 weeks

  5. Pulse in BPM(Beat per Minute)

    Phase 1

    Measured: 48 weeks

  6. Blood Pressure in mmHg

    Phase 1

    Measured: 48 weeks

  7. Weight in Kg

    Phase 1

    Measured: 48 weeks

  8. Height in centimeter

    Phase 1

    Measured: 48 weeks

  9. Laboratory tests-Blood Routine examination

    Phase 1

    Measured: 48 weeks

  10. Laboratory tests-Urine Routine test

    Phase 1

    Measured: 48 weeks

  11. Laboratory tests-Blood biochemistry

    Phase 1

    Measured: 48 weeks

  12. Laboratory tests- Coangulation function

    Phase 1

    Measured: 48 weeks

  13. Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

    Phase 1

    Measured: 48 weeks

  14. 12-lead electrocardiogram (ECG) in QTcF.

    Phase 1

    Measured: 48 weeks

  15. 12-lead electrocardiogram (ECG) in QT.

    Phase 1

    Measured: 48 weeks

  16. 12-lead electrocardiogram (ECG) in QRS.

    Phase 1

    Measured: 48 weeks

  17. 12-lead electrocardiogram (ECG) in HR.

    Phase 1

    Measured: 48 weeks

  18. 12-lead electrocardiogram (ECG) in RR.

    Phase 1

    Measured: 48 weeks

  19. 12-lead electrocardiogram (ECG) in PR.

    Phase 1

    Measured: 48 weeks

  20. ECOG(Eastern Cooperative Oncology Group) score

    Phase 1

    Measured: 48 weeks

  21. Overall Response Rate (ORR)

    Phase 2

    Measured: 64 weeks

Secondary outcomes (30)

  1. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

    Phase 1 and 2

    Measured: 112 weeks

  2. PK Parameter:Time of Maximum Observed Concentration (Tmax)

    Phase 1 and 2

    Measured: 112 weeks

  3. PK Parameter: Area Under the Concentration-time Curve(AUC)

    Phase 1 and 2

    Measured: 112 weeks

  4. PK Parameter: Steady State Maximum Concentration(Cmax,ss)

    Phase 1 and 2

    Measured: 112 weeks

  5. PK Parameter: Steady State Minimum Concentration(Cmin,ss)

    Phase 1 and 2

    Measured: 112 weeks

  6. PK Parameter: Systemic Clearance at Steady State (CLss)

    Phase 1 and 2

    Measured: 112 weeks

  7. PK Parameter: Accumulation Ratio (Rac)

    Phase 1 and 2

    Measured: 48 weeks

  8. PK Parameter: Elimination Half-life (t1/2)

    Phase 1

    Measured: 112 weeks

  9. PK Parameter: Volume of Distribution at Steady-State (Vss)

    Phase 1 and 2

    Measured: 112 weeks

  10. PK Parameter: Degree of Fluctuation (DF)

    Phase 1 and 2

    Measured: 112 weeks

  11. Immunogenicity of LM-101

    Phase 1 and 2; Anti-Drug antibody and Nab (if neccessary) will be tested.

    Measured: 112 weeks

  12. Receptor Occupancy of LM-101

    Phase 1

    Measured: 48 weeks

  13. Biomarker correlation (CD8/CD47/CD68/CD163/PD-L1)

    Phase 1 and 2

    Measured: 112 weeks

  14. Duration of Response (DOR) in Month

    Phase 2

    Measured: 64 weeks

  15. Disease control rate (DCR) in percentage

    Phase 2

    Measured: 64 weeks

  16. progression-free survival (PFS) in Month

    Phase 2

    Measured: 64 weeks

  17. Overall survival (OS) in Month

    Phase 2

    Measured: 64 weeks

  18. Changes of target lesions from baseline in Millimeter.

    Phase 2

    Measured: 64 weeks

  19. Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)

    Phase 2

    Measured: 64 weeks

  20. Temperature in ℃

    Phase 2

    Measured: 64 weeks

  21. Pulse in BPM(Beat per Minute)

    Phase 2

    Measured: 64 weeks

  22. Blood Pressure in mmHg

    Phase 2

    Measured: 64 weeks

  23. Weight in Kg

    Phase 2

    Measured: 64 weeks

  24. Height in centimeter

    Phase 2

    Measured: 64 weeks

  25. Laboratory tests-Blood Routine examination

    Phase 2

    Measured: 64 weeks

  26. Laboratory tests-Urine Routine test

    Phase 2

    Measured: 64 weeks

  27. Laboratory tests-Blood biochemistry

    Phase 2

    Measured: 64 weeks

  28. Laboratory tests- Coangulation function

    Phase 2

    Measured: 64 weeks

  29. 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.

    Phase 2

    Measured: 64 weeks

  30. ECOG(Eastern Cooperative Oncology Group) score

    Phase 2

    Measured: 64 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start11 Jan 2023
  3. Primary completion11 Jan 2027 (estimated)
  4. Study completion11 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
139 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05615974
Sponsor's protocol ID
LM101-01-103
Status last verified
Dec 2024
First submitted
18 Oct 2022
Last updated
19 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cai J, Zhao B, Ji D, Zhou F, Bai S, Fang X, Nie M, Bai B, Zhang Y, Li J, Li H, Li Y, Fei D, Qin X, Qin C, Zhao S, Xia Y, Cai Q. LM-101, an Anti-SIRPalpha Antibody, in Patients with Relapsed/Refractory Lymphoma and Advanced Head and Neck Cancer: An Open-Label, Multicenter, Phase I Trial. Clin Cancer Res. 2026 Jun 15;32(12):2391-2402. doi: 10.1158/1078-0432.CCR-25-2357.

    PubMed 41910591

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LM101, Toripalimab and Rituximab in people with Malignant Tumors, run by LaNova Medicines Limited at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alex Yuan (+8615901815211, alexyuan@lanovamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: 48 weeks). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05615974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.

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