> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/a-phase-i-ii-study-of-lm-2417-in-subjects-with-advanced-aa0d0b83-786d-443d-bbc5-813dcf60cfca
> Record changed: 2026-10-29

# A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

NCT06682780

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

Phase

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

Participants

320

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

Lead sponsor

LaNova Medicines Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

Start date

2025-09-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Short title**

A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Status and phase

**Control arm**

Open label

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Phase**

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Dates

**Completion date**

2029-12-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**First posted**

2024-11-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Registry last updated**

2026-08-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Primary completion date**

2028-12-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Start date**

2025-09-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Size and sites

**Participants**

320

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Planned participants**

320

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Lead sponsor**

LaNova Medicines Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Identifiers

**Registry ID**

NCT06682780

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**ClinicalTrials.gov ID**

NCT06682780

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Study design

**Allocation**

Not randomised

**Model**

Sequential

**Purpose**

Treatment

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Outcomes

### Primary outcomes

1. Incidence of adverse events (AEs)  
Timeframe: 60 weeks  
Phase I/II
2. Incidence of dose-limitingtoxicity (DLT)  
Timeframe: 60 weeks  
Phase I/II
3. Incidence of serious adverse event (SAE)  
Timeframe: 60 weeks  
Phase I/II
4. Temperatures  
Timeframe: 60 weeks  
Phase I/II
5. Pulse in BPM(Beat per Minute)  
Timeframe: 60 weeks  
Phase I/II
6. Blood Pressure in mmHg  
Timeframe: 60 weeks  
Phase I/II
7. Weight in Kg  
Timeframe: 60 weeks  
Phase I/II
8. Height in centimeter  
Timeframe: 60 weeks  
Phase I/II
9. Laboratory tests-Blood Routine examination  
Timeframe: 60 weeks  
Phase I/II
10. Laboratory tests-Urine Routine test  
Timeframe: 60 weeks  
Phase I/II
11. Laboratory tests-Blood biochemistry  
Timeframe: 60 weeks  
Phase I/II
12. Laboratory tests- Coangulation function  
Timeframe: 60 weeks  
Phase I/II
13. Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage  
Timeframe: 60 weeks  
Phase I/II
14. 12-lead electrocardiogram (ECG) in HR  
Timeframe: 60 weeks  
Phase I/II
15. 12-lead electrocardiogram (ECG) in RR  
Timeframe: 60 weeks  
Phase I/II
16. 12-lead electrocardiogram (ECG) in PR  
Timeframe: 60 weeks  
Phase I/II
17. 12-lead electrocardiogram (ECG) in QRS  
Timeframe: 60 weeks  
Phase I/II
18. 12-lead electrocardiogram (ECG) in QT  
Timeframe: 60 weeks  
Phase I/II
19. 12-lead electrocardiogram (ECG) in QTcF  
Timeframe: 60 weeks  
Phase I/II
20. ECOG(Eastern Cooperative Oncology Group) score  
Timeframe: 60 weeks  
Phase I/II
21. Overall Response Rate (ORR)  
Timeframe: 76 weeks  
Phase I/II

### Secondary outcomes

1. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)  
Timeframe: 112 weeks  
Phase I/II
2. PK Parameter:Time of Maximum Observed Concentration (Tmax)  
Timeframe: 112 weeks  
Phase I/II
3. PK Parameter: Area Under the Concentration-time Curve(AUC)  
Timeframe: 112 weeks  
Phase I/II
4. PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)  
Timeframe: 112 weeks  
Phase I/II
5. PK Parameter: Steady State Minimum Concentration(Cmin,ss)  
Timeframe: 112 weeks  
Phase I/II
6. PK Parameter: Systemic Clearance at Steady State (CLss)  
Timeframe: 112 weeks  
Phase I/II
7. PK Parameter: Accumulation Ratio (Rac)  
Timeframe: 112 weeks  
Phase I/II
8. PK Parameter: Elimination Half-life (t1/2)  
Timeframe: 112 weeks  
Phase I/II
9. PK Parameter: Volume of Distribution at Steady-State (Vss)  
Timeframe: 112 weeks  
Phase I/II
10. PK Parameter: Degree of Fluctuation (DF)  
Timeframe: 112 weeks  
Phase I/II
11. Immunogenicity of LM-2417  
Timeframe: 112 weeks  
Phase I/II
12. Biomarker correlation(NaPi2b)  
Timeframe: 112 weeks  
Phase I/II
13. Duration of Response (DOR) in Month  
Timeframe: 64 weeks  
Phase I/II
14. Disease control rate (DCR) in percentage  
Timeframe: 64 weeks  
Phase I/II
15. progression-free survival (PFS) in Month  
Timeframe: 64 weeks  
Phase I/II
16. Safety: AE/SAE (Number of participants with treatment-related adverse events as Overall survival (OS) in Month  
Timeframe: 64 weeks  
Phase I/II
17. Changes of target lesions from baseline in Millimeter  
Timeframe: 64 weeks  
Phase I/II
18. 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)  
Timeframe: 64 weeks  
Phase I/II

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

80 Years

**Healthy volunteers**

No

### 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 18-80 years old (including boundary values) , 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, or currently lack or are intolerant of, standard therapy.
6. Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.
7. At least one evaluable lesion.
8. Subjects must show appropriate organ and marrow function inlaboratory 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.

Single-agent dose of 6mg/kg, 12mg/kg and and combined cohort：Subjects tested positive for biomarkers.

### Exclusion criteria

1. Previously received with same target therapy.
2. Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417.
3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, 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. Subject who have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
8. Subjects with known hypersensitivity to antibody therapy;
9. 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.
10. Previous or current known autoimmune disease.
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 vaccine or live attenuated vaccines within 28 days prior to the first dosing of LM-2417.;
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 within28 days prior to the first dosing of LM-2417.
15. Subject who have history of severe cardiovascular disease.
16. Subjects who have uncontrolled or severe illness.
17. HIV infection, active HBV or HCV infection.
18. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.
19. Child-bearing potential female who have positive results in pregnancy test or are lactating.
20. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
21. Subject who is judged as not eligible to participate in this study by the investigator.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Sites

- FuDan University Shanghai Cancer CenterShanghai, ChinaRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06682780)

## Related records

### Drugs (5)

- [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md)
- [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md)
- [Lenvatinib](https://trialight.com/data/asset/lenvatinib-44bdd81b-9a97-4a26-9b2b-0d1d8fd79032.md)
- [Niraparib](https://trialight.com/data/asset/niraparib-97fb35aa-5d31-428f-875b-0f58bef184c3.md)
- [Toripalimab](https://trialight.com/data/asset/toripalimab-92e6b353-a6c4-4e1e-a99f-559038ba7177.md)

### Lead sponsors (1)

- [LaNova Medicines Limited](https://trialight.com/data/company/lanova-medicines-limited-3a5f6703-f992-4113-8baa-570d8c8ee1f6.md)

### Targets (21)

- [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md)
- [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md)
- [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md)
- [PARP1](https://trialight.com/data/target/parp1-78c558f2-1477-56b9-9f9f-c1e925a07421.md)
- [PARP2](https://trialight.com/data/target/parp2-2551f72f-f11f-5c9e-9253-3f01dfbad379.md)
- [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md)
- [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md)
- [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md)
- [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md)
- [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md)
- [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md)
- [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md)
- [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md)
- [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md)
- [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md)
- [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md)
- [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md)
- [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md)
- [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md)
- [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md)

---

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