Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
NCT06682780

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

Led by LaNova Medicines Limited · Updated on 2025-09-25

320

Participants Needed

1

Research Sites

219 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to participate and sign informed consent before any study procedures
  • Age between 18 and 80 years, male or female
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Histological or cytological confirmation of recurrent or refractory advanced solid tumors
  • Availability of archived or fresh tumor tissue specimens for testing
  • At least one lesion that can be evaluated
  • Adequate organ and marrow function based on lab tests within 7 days before first dose
  • Women of childbearing potential must use highly effective contraception before, during, and for 6 months after treatment
  • Ability to communicate well with investigators and follow study requirements
Not Eligible

You will not qualify if you...

  • Prior treatment with the same targeted therapy
  • Participation in another interventional clinical trial within 28 days before first LM-2417 dose
  • Anti-tumor treatment (radiotherapy, chemotherapy, endocrine therapy, immunotherapy) within 21 days before first LM-2417 dose
  • Unresolved adverse events from prior therapy worse than grade 1 CTCAE v5.0
  • Poorly controlled tumor-related pain
  • Symptomatic or active central nervous system metastases
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
  • Known allergy to antibody therapy
  • Use of systemic corticosteroids (>10 mg prednisone daily) for more than 7 days or other immunosuppressants within 2 weeks before first LM-2417 dose
  • Current or previous autoimmune disease
  • Interstitial lung disease or history of pneumonitis needing glucocorticoids
  • Live vaccine within 28 days before first LM-2417 dose
  • Use of therapeutic doses of anticoagulants like heparin or vitamin K antagonists
  • Major surgery or interventional treatment within 28 days before first LM-2417 dose
  • History of severe cardiovascular disease
  • Uncontrolled or severe illness
  • HIV infection or active hepatitis B or C infection
  • Other active invasive cancers within 5 years prior to screening
  • Positive pregnancy test or breastfeeding in women of childbearing potential
  • Psychiatric disorders affecting compliance
  • Investigator judgment of unsuitability for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Actively Recruiting

Loading map...

Research Team

A

Alex Yuan

CONTACT

P

Paul Kong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here