LM-2417 for advanced solid tumors (Phase 1/2)

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 trial will test the safety and best dose of LM-2417 alone or combined with other cancer drugs in adults with advanced solid tumors who have exhausted or cannot tolerate standard therapies.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: LaNova Medicines Limited (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06682780 on ClinicalTrials.gov

What this trial studies

LM-2417 is being given to adults with recurrent or refractory advanced solid tumors in a Phase 1/2 dose-escalation and expansion design to determine safety, tolerability and the recommended Phase 2 dose or maximum tolerated dose. The agent is studied both as a single agent and in combination with docetaxel, carboplatin, a PD‑1 antibody (toripalimab/tirelizumab), or the PARP inhibitor niraparib. Key procedures include baseline and on-study tumor tissue collection, regular safety labs, and imaging of at least one measurable lesion to monitor response. Eligible patients must be 18–80 years old with ECOG 0–1 and adequate organ function.

Who should consider this trial

Good fit: Adults aged 18–80 with histologically or cytologically confirmed recurrent or refractory advanced solid tumors, ECOG performance status 0–1, at least one measurable lesion, adequate organ and marrow function, and ability to provide tumor tissue would be appropriate candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), life expectancy under three months, inability to provide required tissue samples or to use effective contraception, or those who are pregnant are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, LM-2417 could become a new treatment option or part of an effective combination for people with advanced solid tumors who have limited standard options.

How similar studies have performed: Combining novel targeted agents with chemotherapy, PD‑1 inhibitors, or PARP inhibitors has shown promise in other cancers, but LM‑2417 itself appears to be a new agent with no publicly reported efficacy data yet.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• FuDan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Alex Yuan

Conditions Advanced Solid Tumor