Advanced Solid TumorPhase 1/2NCT06682780
A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
A Phase 1/2 study testing LM-2417, Docetaxel and Toripalimab/Tirelizumab in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 1 site in China.
Trial summary
This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- LM-2417, Docetaxel and Toripalimab/Tirelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2025to 1 Dec 2029
- 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 to 80 years
- 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 18-80 years old (including boundary values) , 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, or currently lack or are intolerant of, standard therapy.
- Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.
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- At least one evaluable lesion.
- Subjects must show appropriate organ and marrow function inlaboratory 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.
- Single-agent dose of 6mg/kg, 12mg/kg and and combined cohort：Subjects tested positive for biomarkers.
Who cannot join
- Previously received with same target therapy.
- Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417.
- Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, 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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- Subject who have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Subjects with known hypersensitivity to antibody therapy;
- Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) for more than 7 days or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-2417.
- Previous or current known autoimmune disease.
- 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 vaccine or live attenuated vaccines within 28 days prior to the first dosing of LM-2417.;
- Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
- Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of LM-2417.
- Subject who have history of severe cardiovascular disease.
- Subjects who have uncontrolled or severe illness.
- HIV infection, active HBV or HCV infection.
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Xiaohua Wu, Dr
Hongxia Wang
About this study
Official title: An Open-label, Dose-escalation, and Dose-expansion Phase I/II Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors
This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.
- Conditions
- Advanced Solid Tumor
- Being tested
- LM-2417, Docetaxel, Toripalimab/Tirelizumab, Carboplatin, Niraparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-2417Drug
Q2W/Q3W,Intravenous Drip
DocetaxelDrug
Q3W,Intravenous Drip
Toripalimab/TirelizumabDrug
Q3W,Intravenous Drip
CarboplatinDrug
Q3W,Intravenous Drip
NiraparibDrug
QD,Oral Administration
LenvatinibDrug
QD,Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| LM2417 Dose Escalation(Q2W/Q3W) | Experimental | Not described Receives: Drug: LM-2417 |
| LM-2417 combination therapy exploratory | Experimental | Not described Receives: Drug: LM-2417; Drug: Docetaxel; Drug: Toripalimab/Tirelizumab; Drug: Carboplatin; Drug: Niraparib; Drug: Lenvatinib |
| LM-2417 combination expansion | Experimental | Not described Receives: Drug: LM-2417; Drug: Docetaxel; Drug: Toripalimab/Tirelizumab; Drug: Carboplatin; Drug: Niraparib; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Phase I/II
Measured: 60 weeks
Incidence of dose-limitingtoxicity (DLT)
Phase I/II
Measured: 60 weeks
Incidence of serious adverse event (SAE)
Phase I/II
Measured: 60 weeks
Temperatures
Phase I/II
Measured: 60 weeks
Pulse in BPM(Beat per Minute)
Phase I/II
Measured: 60 weeks
Blood Pressure in mmHg
Phase I/II
Measured: 60 weeks
Weight in Kg
Phase I/II
Measured: 60 weeks
Height in centimeter
Phase I/II
Measured: 60 weeks
Laboratory tests-Blood Routine examination
Phase I/II
Measured: 60 weeks
Laboratory tests-Urine Routine test
Phase I/II
Measured: 60 weeks
Laboratory tests-Blood biochemistry
Phase I/II
Measured: 60 weeks
Laboratory tests- Coangulation function
Phase I/II
Measured: 60 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase I/II
Measured: 60 weeks
12-lead electrocardiogram (ECG) in HR
Phase I/II
Measured: 60 weeks
12-lead electrocardiogram (ECG) in RR
Phase I/II
Measured: 60 weeks
12-lead electrocardiogram (ECG) in PR
Phase I/II
Measured: 60 weeks
12-lead electrocardiogram (ECG) in QRS
Phase I/II
Measured: 60 weeks
12-lead electrocardiogram (ECG) in QT
Phase I/II
Measured: 60 weeks
12-lead electrocardiogram (ECG) in QTcF
Phase I/II
Measured: 60 weeks
ECOG(Eastern Cooperative Oncology Group) score
Phase I/II
Measured: 60 weeks
Overall Response Rate (ORR)
Phase I/II
Measured: 76 weeks
Secondary outcomes (18)
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Phase I/II
Measured: 112 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Phase I/II
Measured: 112 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)
Phase I/II
Measured: 112 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Phase I/II
Measured: 112 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Phase I/II
Measured: 112 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Phase I/II
Measured: 112 weeks
PK Parameter: Accumulation Ratio (Rac)
Phase I/II
Measured: 112 weeks
PK Parameter: Elimination Half-life (t1/2)
Phase I/II
Measured: 112 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Phase I/II
Measured: 112 weeks
PK Parameter: Degree of Fluctuation (DF)
Phase I/II
Measured: 112 weeks
Immunogenicity of LM-2417
Phase I/II
Measured: 112 weeks
Biomarker correlation(NaPi2b)
Phase I/II
Measured: 112 weeks
Duration of Response (DOR) in Month
Phase I/II
Measured: 64 weeks
Disease control rate (DCR) in percentage
Phase I/II
Measured: 64 weeks
progression-free survival (PFS) in Month
Phase I/II
Measured: 64 weeks
Safety: AE/SAE (Number of participants with treatment-related adverse events as Overall survival (OS) in Month
Phase I/II
Measured: 64 weeks
Changes of target lesions from baseline in Millimeter
Phase I/II
Measured: 64 weeks
AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)
Phase I/II
Measured: 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start17 Sep 2025
- Primary completion25 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 320 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
- NCT06682780
- Sponsor's protocol ID
- LM2417-01-103
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2024
- Last updated
- 28 Aug 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation, and Dose-expansion Phase I/II Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06682780
- Acronym / sponsor ID
- LM2417-01-103
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- LaNova Medicines LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 25 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 12 Nov 2024 (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.
This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LM2417 Dose Escalation(Q2W/Q3W) | Experimental | Drug: LM-2417 |
| LM-2417 combination therapy exploratory | Experimental | Drug: LM-2417, Drug: Docetaxel, Drug: Toripalimab/Tirelizumab, Drug: Carboplatin, Drug: Niraparib, Drug: Lenvatinib |
| LM-2417 combination expansion | Experimental | Drug: LM-2417, Drug: Docetaxel, Drug: Toripalimab/Tirelizumab, Drug: Carboplatin, Drug: Niraparib, Drug: Lenvatinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Aged 18-80 years old (including boundary values) , 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, or currently lack or are intolerant of, standard therapy.
Key exclusion criteria (21 listed)
- Previously received with same target therapy.
- Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417.
- Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, 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.
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-2417Q2W/Q3W,Intravenous Drip | Drug | LM-2417 combination expansion, LM-2417 combination therapy exploratory, LM2417 Dose Escalation(Q2W/Q3W) |
| DocetaxelQ3W,Intravenous Drip | Drug | LM-2417 combination expansion, LM-2417 combination therapy exploratory |
| Toripalimab/TirelizumabQ3W,Intravenous Drip | Drug | LM-2417 combination expansion, LM-2417 combination therapy exploratory |
| CarboplatinQ3W,Intravenous Drip | Drug | LM-2417 combination expansion, LM-2417 combination therapy exploratory |
| NiraparibQD,Oral Administration | Drug | LM-2417 combination expansion, LM-2417 combination therapy exploratory |
| LenvatinibQD,Oral Administration | Drug | LM-2417 combination expansion, LM-2417 combination therapy exploratory |
Primary outcome
Incidence of adverse events (AEs)
Time frame: 60 weeks
Phase I/II
Incidence of dose-limitingtoxicity (DLT)
Time frame: 60 weeks
Phase I/II
Incidence of serious adverse event (SAE)
Time frame: 60 weeks
Phase I/II
Temperatures
Time frame: 60 weeks
Phase I/II
Pulse in BPM(Beat per Minute)
Time frame: 60 weeks
Phase I/II
Blood Pressure in mmHg
Time frame: 60 weeks
Phase I/II
Weight in Kg
Time frame: 60 weeks
Phase I/II
Height in centimeter
Time frame: 60 weeks
Phase I/II
Laboratory tests-Blood Routine examination
Time frame: 60 weeks
Phase I/II
Laboratory tests-Urine Routine test
Time frame: 60 weeks
Phase I/II
Laboratory tests-Blood biochemistry
Time frame: 60 weeks
Phase I/II
Laboratory tests- Coangulation function
Time frame: 60 weeks
Phase I/II
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Time frame: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in HR
Time frame: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in RR
Time frame: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in PR
Time frame: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in QRS
Time frame: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in QT
Time frame: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in QTcF
Time frame: 60 weeks
Phase I/II
ECOG(Eastern Cooperative Oncology Group) score
Time frame: 60 weeks
Phase I/II
Overall Response Rate (ORR)
Time frame: 76 weeks
Phase I/II
18 secondary outcomes
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Time frame: 112 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Time frame: 112 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)
Time frame: 112 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Time frame: 112 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Time frame: 112 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Time frame: 112 weeks
PK Parameter: Accumulation Ratio (Rac)
Time frame: 112 weeks
PK Parameter: Elimination Half-life (t1/2)
Time frame: 112 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Time frame: 112 weeks
PK Parameter: Degree of Fluctuation (DF)
Time frame: 112 weeks
Immunogenicity of LM-2417
Time frame: 112 weeks
Biomarker correlation(NaPi2b)
Time frame: 112 weeks
Duration of Response (DOR) in Month
Time frame: 64 weeks
Disease control rate (DCR) in percentage
Time frame: 64 weeks
progression-free survival (PFS) in Month
Time frame: 64 weeks
Safety: AE/SAE (Number of participants with treatment-related adverse events as Overall survival (OS) in Month
Time frame: 64 weeks
Changes of target lesions from baseline in Millimeter
Time frame: 64 weeks
AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)
Time frame: 64 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 28 Aug 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.
1 site 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-2417, Docetaxel and Toripalimab/Tirelizumab 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 11 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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 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 Lingli Zhao (+8618901636324, linglizhao@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: 60 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?
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 28 Aug 2026.