AzTrials
AzTrials

Advanced Solid TumorPhase 2NCT06873854

A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours

A Phase 2 study testing LM-108 and Toripalimab in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Based on overall response rate (ORR) as assessed by the Independent Review Committee (IRC) against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria for Solid Tumor Efficacy, To evaluate the efficacy of LM-108 in combination with Toripalimab in patients with advanced malignant solid tumours with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LM-108 and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
26 Mar 2025to 26 Jan 2030
Phase
Phase 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 with advanced solid tumors diagnosed by pathology have evidence of advanced stage or metastasis that cannot be surgically removed. And the MSI-H status will be confirmed by central laboratory designated of the sponsor.
  • Aged 18.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • At least one measurable lesion.
  • Subjects who have failed previous monotherapy with anti-PD-1/PD-L1 drugs or combination (synchronous or sequential) with other systemic treatments and unresectable or metastatic late stage MSI-H/dMMR solid tumors.
  • Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.
Show all 10Show fewer
  • Any adverse event from prior anti-tumor therapy and surgery has recovered to ≤ grade 1 of CTCAE v5.0.
  • Subjects must show appropriate organ and marrow function in laboratory examinations.
  • Women of childbearing potential (WOCBP) and Male participants must agree to use one medically recognized contraceptive measures of contraception, during the study and for 6 months after the last dose of study drug.
  • Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.

Who cannot join

  • Subjects with symptomatic/active central nervous system (CNS) metastases.
  • Subject who have uncontrollable pleural effusion, pericardial effusion, and ascites despite treatment such as puncture and drainage Within 14 days prior to enrollment; Pericardial effusion accompanied by clinical symptoms or moderate or above.
  • Subjects' weight decreased by more than 20% within the first 2 months of enrollment.
  • Poorly controlled tumor-related pain.
  • Subjects who received anti-tumour treatment, , major surgery, immunosuppressive drugs and live attenuated vaccines before enrollment.
  • Subjects have received anti-tumor immunotherapy and experienced ≥ grade 3 immune related adverse events (irAE) or ≥ grade 2 immune related myocarditis.
Show all 21Show fewer
  • Subjects who have other cancers within 5 years prior to entering the research.
  • Previous or current known autoimmune disease.
  • Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies; Arterial/venous thrombotic events that occurred within the first 6 months of enrollment.
  • Present peripheral neuropathy of grade>1 .
  • Subjects who have a history of gastrointestinal perforation and/or gastrointestinal fistula within the 6 months prior to enrollment.
  • Subjects who have been clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction Within 6 months prior to starting the study treatment.
  • Presence of interstitial lung disease, non infectious pneumonia, or uncontrolled systemic diseases.
  • Known to be allergic to the investigational drug or any of its excipients; Or have experienced severe allergic reactions to other monoclonal antibodies.
  • HIV infection, active HBV or HCV infection.
  • Subject who have clinical symptoms or diseases of the heart that have not been well controlled.
  • Subjects who take Systemic use of antibiotics for more than 7 days within the first 4 weeks prior to enrollment, or unexplained fever>38.5 ° C during screening/before first administration .
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Subjects who have participated in any other drug clinical studies within 4 weeks prior to enrollment, or have not exceeded 5 half lives since the last study medication.
  • Known history of abuse or drug use of psychotropic substances.
  • Subjects who have other serious physical or mental illnesses or laboratory abnormalities and judged as not eligible to participate in this study by the investigator.

Trial locations and contacts

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

Alex Yuan contact

+8615901815211

alexyuan@lanovamed.com

Paul Kong contact

+8613564682439

paulkong@lanovamed.com

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Lin Shen, 13911219511, linshenpku@163.com

Other trials in China

About this study

Official title: Evaluation of a Phase II, Single-arm, Multicenter, Open-label Clinical Study on LM-108 Injection in Combination With Toripalimab for Advanced Malignant Solid Tumors in Patients With Unresectable or Metastatic Microsatellite Highly Unstable (MSI H) or Mismatch Repair Defects (dMMR) Who Have Failed Previous Treatment With Anti-PD-1/PD-L1 Drugs

Based on overall response rate (ORR) as assessed by the Independent Review Committee (IRC) against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria for Solid Tumor Efficacy, To evaluate the efficacy of LM-108 in combination with Toripalimab in patients with advanced malignant solid tumours with unresectable or metastatic MSI-H/dMMR who have failed previous anti-PD-1 /PD-L1 therapy.

Being tested
LM-108, Toripalimab

What participants receive

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

  • LM-108Drug

    Q3W, Intravenous Drip

  • ToripalimabDrug

    Q3W, Intravenous Drip

Study groups in NCT06873854
Study groupRoleWhat they receive
LM-108 in Combination with ToripalimabExperimentalNot described
Receives: Drug: LM-108; Drug: Toripalimab

What is being measured

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

  1. ORR

    Overall Response Rate assessed by Independent Review Committee against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: 104 weeks

Secondary outcomes (35)

  1. AEs

    Incidence of adverse events

    Measured: 104 weeks

  2. SAEs

    Incidence of serious adverse events

    Measured: 104 weeks

  3. AE/SAE

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: 104 weeks

  4. DOR

    Duration of response assessed by Independent Review Committee against the RECIST v1.1

    Measured: 104 weeks

  5. DCR

    Disease control rate (DCR = CR + PR + SD) assessed by Independent Review Committee against the RECIST v1.1

    Measured: 104 weeks

  6. PFS

    Progression-free survival assessed by Independent Review Committee against the RECIST v1.1

    Measured: 104 weeks

  7. Progression-free survival Rates

    Independent Review Committee evaluated the Progression-free survival rates at 3 and 6 months based on RECIST v1.1

    Measured: 104 weeks

  8. ORR

    Overall Response Rate assessed by investigator against the RECIST v1.1

    Measured: 104 weeks

  9. DOR

    Duration of response assessed by investigator against the RECIST v1.1

    Measured: 104 weeks

  10. DCR

    Disease control rate (DCR = CR + PR + SD) assessed by investigator against the RECIST v1.1

    Measured: 104 weeks

  11. PFS

    Progression-free survival assessed by investigator against the RECIST v1.1

    Measured: 104 weeks

  12. Progression-free survival Rates

    Investigator evaluated the Progression-free survival rates at 3 and 6 months based on RECIST v1.1

    Measured: 104 weeks

  13. OS

    Overall survival

    Measured: 104 weeks

  14. OS rates

    Overall survival rates

    Measured: 104 weeks

  15. Temperatures

    Temperatures

    Measured: 104 weeks

  16. Pulse in BPM

    Beat per Minute

    Measured: 104 weeks

  17. Blood Pressure

    Blood Pressure in mmHg，Both systolic pressure and diastolic pressure

    Measured: 104 weeks

  18. Weight

    Weight in Kg

    Measured: 104 weeks

  19. Height

    Height in centimeter

    Measured: 104 weeks

  20. Complete Blood Count

    Measured: 104 weeks

  21. Urine Routine test

    Laboratory tests-Urine Routine test

    Measured: 104 weeks

  22. Blood biochemistry

    Laboratory tests-Blood biochemistry

    Measured: 104 weeks

  23. Coagulation function

    Laboratory tests-Coagulation function

    Measured: 104 weeks

  24. Thyroid function

    Laboratory tests-Thyroid function

    Measured: 104 weeks

  25. Stool routine examination

    Laboratory tests-Stool routine examination

    Measured: 104 weeks

  26. Virological examination

    Laboratory tests-Virological examination

    Measured: 104 weeks

  27. Pregnancy check

    Laboratory tests-Pregnancy check

    Measured: 104 weeks

  28. LVEF

    Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

    Measured: 104 weeks

  29. HR

    Electrocardiogram (ECG) in HR

    Measured: 104 weeks

  30. RR

    Electrocardiogram (ECG) in RR

    Measured: 104 weeks

  31. PR

    Electrocardiogram (ECG) in PR

    Measured: 104 weeks

  32. QRS

    Electrocardiogram (ECG) in QRS

    Measured: 104 weeks

  33. QT

    Electrocardiogram (ECG) in QT

    Measured: 104 weeks

  34. QTcF

    Electrocardiogram (ECG) in QTcF

    Measured: 104 weeks

  35. ECOG score

    Eastern Cooperative Oncology Group score

    Measured: 104 weeks

Timeline

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

  1. First posted13 Mar 2025
  2. Study start26 Mar 2025 (estimated)
  3. Primary completion26 Jan 2028 (estimated)
  4. Study completion26 Jan 2030 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873854
Sponsor's protocol ID
LM-108-II-01
Status last verified
Mar 2025
First submitted
13 Feb 2025
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LM-108 and Toripalimab in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 1 site 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 21 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: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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?

ORR (time frame: 104 weeks). 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 NCT06873854.

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 13 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in