Advanced Solid Tumor CancerPhase 1/2LM364NCT07847905
A Phase I/II of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors
A Phase 1/2 study testing LM-364 for injection and Tislelizumab in people with Advanced Solid Tumor Cancer, run by LaNova Medicines Limited at 8 sites in China.
Trial summary
For Phase I, 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-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor Cancer
- What is being tested?
- LM-364 for injection and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 8 sitesChina
- Study dates
- 19 Oct 2026to 19 Aug 2031
- 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
- Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Participants must be ≥18 years or the legal age of consent at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥ 3 months.
- Adequate organ and bone marrow function as defined by protocol.
- Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study.
Who cannot join
- Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.
- Participants with uncontrolled tumour-related pain.
- Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.
- Participants who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-364.
- Participants who have severe cardiovascular disease.
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- Participants who have uncontrolled or severe illness.
- Participants who have a history of immunodeficiency disease.
- Participants with a known history of autoimmune disease.
- Child-bearing potential female who have positive results in pregnancy test or are lactating.
- Participants who have psychiatric illness or disorders that may preclude study compliance.
- Participants who is judged as not eligible to participate in this study by the investigator.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Ning Li
Hunan cancer hospital
Changsha, Hunan
Shusuan Jiang, Dr.
Hunan cancer hospital
Changsha, Hunan
Xinchun Li, Dr.
Liaocheng People's Hospital
Liaocheng, Shandong
Baozhong Wang
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaohua Wu, Dr.
Jian Zhang, Dr.
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei
Zhiguo Luo
The First School of Medicine, School of Information and Engineering,The First Affliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Yongyong Lu, Dr.
the first affiliated hospital of Henan medical University
Xinxiang, Henan
Weizheng Kou, Dr.
About this study
Official title: 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-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors
For Phase I, 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-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors.
For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumor Cancer
- Being tested
- LM-364 for injection, Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-364 for injectionDrug
Q3W, Intravenous infusion
TislelizumabDrug
Q3W, Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| LM-364 Monotherapy | Experimental | Not described Receives: Drug: LM-364 for injection |
| LM-364 Combination Therapy | Experimental | Not described Receives: Drug: LM-364 for injection; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Phase I
Measured: 78 Weeks
Adverse events (AEs)
Phase I
Measured: 78 weeks
serious adverse events (SAEs)
Phase I
Measured: 78 weeks
Temperatures
Phase I
Measured: 78 weeks
Pulse in BPM
Phase I
Measured: 78 weeks
Blood Pressure in mmHg
Phase I
Measured: 78 weeks
Weight in Kg
Phase I
Measured: 78 weeks
Height in centimeter
Phase I
Measured: 78 weeks
Laboratory examinations--Blood Routine examination-Complete Blood Count
Phase I
Measured: 78 weeks
Laboratory examinations--Blood biochemistry- Electrolytes and Metabolic Parameters
Phase I
Measured: 78 weeks
Laboratory examinations-Urine Routine test-Urinalysis
Phase I
Measured: 78 weeks
Laboratory examinations--Coagulation function-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT)
Phase I
Measured: 78 weeks
Laboratory examinations--Thyroid function-For the detection of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4)
Phase I
Measured: 78 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in HR
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in RR
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in PR
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in QRS
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in QT
Phase I
Measured: 78 weeks
12-lead electrocardiogram (ECG) in QTcF
Phase I
Measured: 78 weeks
ECOG score-Cooperative Oncology Group score
Phase I
Measured: 78 weeks
Objective Response Rate (ORR)
Phase II
Measured: 52 weeks
Secondary outcomes (38)
PK Parameter: Area Under the Concentration-time Curve(AUC)
Phase I/II
Measured: 130 week
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Phase I/II
Measured: 130 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Phase I/II
Measured: 130 weeks
PK Parameter: Elimination Half-life (T1/2)
Phase I/II
Measured: 130 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Phase I/II
Measured: 130 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Phase I/II
Measured: 130 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Phase I/II
Measured: 130 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Phase I/II
Measured: 130 weeks
PK Parameter: Accumulation Ratio (Rac)
Phase I/II
Measured: 130 weeks
PK Parameter: Degree of Fluctuation (DF)
Phase I/II
Measured: 130 weeks
Immunogenicity testing-Anti-drug antibody
Phase I/II
Measured: 130 weeks
Immunogenicity testing-neutralizing antibody (Nab)
Phase I/II
Measured: 130 weeks
Objective response rate (ORR)
Phase I
Measured: 78 weeks
Duration of response (DOR)
Phase I/II
Measured: 130 weeks
Disease control rate (DCR = CR + PR + SD)
Phase I/II
Measured: 130 weeks
Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Phase I/II
Measured: 130 weeks
Overall survival (OS)
Phase I/II
Measured: 130 weeks
Changes of target lesions from baseline in Millimeter
Phase I/II
Measured: 130 weeks
QTc-PK relationship -> Correlation concentrations (total antibody, free DXd) vs ΔQTcF (Fridericia's correction)
Phase I
Measured: 78 weeks
Incidence of adverse events (AEs)
Phase II
Measured: 52 weeks
Incidence of serious adverse events (SAEs)
Phase II
Measured: 52 weeks
Temperature (Celsius)
Phase II
Measured: 52 weeks
Pulse in BPM(Beat per Minute)
Phase II
Measured: 52 weeks
Blood Pressure in mmHg
Phase II
Measured: 52 weeks
Weight in Kg
Phase II
Measured: 52 weeks
Height in centimeters
Phase II
Measured: 52 weeks
Laboratory examinations--Blood Routine examination-Complete Blood Count
Phase II
Measured: 52 weeks
Laboratory tests-Urine Routine test-Urinalysis
Phase II
Measured: 52 weeks
Laboratory tests-Blood biochemistry- Electrolytes and Metabolic Parameters
Phase II
Measured: 52 weeks
Laboratory tests- Coagulation function-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT)
Phase II
Measured: 52 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase II
Measured: 52 weeks
12-lead electrocardiogram (ECG) in HR
Phase II
Measured: 52 weeks
12-lead electrocardiogram (ECG) in RR
Phase II
Measured: 52 weeks
12-lead electrocardiogram (ECG) in PR
Phase II
Measured: 52 weeks
12-lead electrocardiogram (ECG) in QRS
Phase II
Measured: 52 weeks
12-lead electrocardiogram (ECG) in QT
Phase II
Measured: 52 weeks
12-lead electrocardiogram (ECG) in QTcF
Phase II
Measured: 52 weeks
Eastern Cooperative Oncology Group score
Phase II
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start19 Oct 2026 (estimated)
- Primary completion19 Oct 2030 (estimated)
- Study completion19 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor CancerStudies of the same condition, open and under way.
- More trials run by LaNova Medicines LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LaNova Medicines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847905
- Sponsor's protocol ID
- LM364-01-103
- Acronym
- LM364
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07847905
- Acronym / sponsor ID
- LM364 / LM364-01-103
- Conditions
- Advanced Solid Tumor Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- LaNova Medicines LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 19 Oct 2030 (estimated)
- Study completion
- 19 Aug 2031 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For Phase I, 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-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors.
For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LM-364 Monotherapy | Experimental | Drug: LM-364 for injection |
| LM-364 Combination Therapy | Experimental | Drug: LM-364 for injection, Drug: Tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Participants must be ≥18 years or the legal age of consent at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥ 3 months.
- Adequate organ and bone marrow function as defined by protocol.
Key exclusion criteria (12 listed)
- Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.
- Participants with uncontrolled tumour-related pain.
- Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.
- Participants who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-364.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LM-364 for injectionQ3W, Intravenous infusion | Drug | LM-364 Combination Therapy, LM-364 Monotherapy |
| TislelizumabQ3W, Intravenous infusion | Drug | LM-364 Combination Therapy |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 78 Weeks
Phase I
Adverse events (AEs)
Time frame: 78 weeks
Phase I
serious adverse events (SAEs)
Time frame: 78 weeks
Phase I
Temperatures
Time frame: 78 weeks
Phase I
Pulse in BPM
Time frame: 78 weeks
Phase I
Blood Pressure in mmHg
Time frame: 78 weeks
Phase I
Weight in Kg
Time frame: 78 weeks
Phase I
Height in centimeter
Time frame: 78 weeks
Phase I
Laboratory examinations--Blood Routine examination-Complete Blood Count
Time frame: 78 weeks
Phase I
Laboratory examinations--Blood biochemistry- Electrolytes and Metabolic Parameters
Time frame: 78 weeks
Phase I
Laboratory examinations-Urine Routine test-Urinalysis
Time frame: 78 weeks
Phase I
Laboratory examinations--Coagulation function-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT)
Time frame: 78 weeks
Phase I
Laboratory examinations--Thyroid function-For the detection of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4)
Time frame: 78 weeks
Phase I
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in HR
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in RR
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in PR
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QRS
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QT
Time frame: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QTcF
Time frame: 78 weeks
Phase I
ECOG score-Cooperative Oncology Group score
Time frame: 78 weeks
Phase I
Objective Response Rate (ORR)
Time frame: 52 weeks
Phase II
38 secondary outcomes
PK Parameter: Area Under the Concentration-time Curve(AUC)
Time frame: 130 week
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Time frame: 130 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Time frame: 130 weeks
PK Parameter: Elimination Half-life (T1/2)
Time frame: 130 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Time frame: 130 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Time frame: 130 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Time frame: 130 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Time frame: 130 weeks
PK Parameter: Accumulation Ratio (Rac)
Time frame: 130 weeks
PK Parameter: Degree of Fluctuation (DF)
Time frame: 130 weeks
Immunogenicity testing-Anti-drug antibody
Time frame: 130 weeks
Immunogenicity testing-neutralizing antibody (Nab)
Time frame: 130 weeks
Objective response rate (ORR)
Time frame: 78 weeks
Duration of response (DOR)
Time frame: 130 weeks
Disease control rate (DCR = CR + PR + SD)
Time frame: 130 weeks
Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: 130 weeks
Overall survival (OS)
Time frame: 130 weeks
Changes of target lesions from baseline in Millimeter
Time frame: 130 weeks
QTc-PK relationship -> Correlation concentrations (total antibody, free DXd) vs ΔQTcF (Fridericia's correction)
Time frame: 78 weeks
Incidence of adverse events (AEs)
Time frame: 52 weeks
Incidence of serious adverse events (SAEs)
Time frame: 52 weeks
Temperature (Celsius)
Time frame: 52 weeks
Pulse in BPM(Beat per Minute)
Time frame: 52 weeks
Blood Pressure in mmHg
Time frame: 52 weeks
Weight in Kg
Time frame: 52 weeks
Height in centimeters
Time frame: 52 weeks
Laboratory examinations--Blood Routine examination-Complete Blood Count
Time frame: 52 weeks
Laboratory tests-Urine Routine test-Urinalysis
Time frame: 52 weeks
Laboratory tests-Blood biochemistry- Electrolytes and Metabolic Parameters
Time frame: 52 weeks
Laboratory tests- Coagulation function-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT)
Time frame: 52 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Time frame: 52 weeks
12-lead electrocardiogram (ECG) in HR
Time frame: 52 weeks
12-lead electrocardiogram (ECG) in RR
Time frame: 52 weeks
12-lead electrocardiogram (ECG) in PR
Time frame: 52 weeks
12-lead electrocardiogram (ECG) in QRS
Time frame: 52 weeks
12-lead electrocardiogram (ECG) in QT
Time frame: 52 weeks
12-lead electrocardiogram (ECG) in QTcF
Time frame: 52 weeks
Eastern Cooperative Oncology Group score
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LM-364 for injection and Tislelizumab in people with Advanced Solid Tumor Cancer, run by LaNova Medicines Limited at 8 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 6 inclusion and 12 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Dose limiting toxicity (DLT) (time frame: 78 Weeks). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.