NCT07387081

Brief Summary

This study is to evaluate the efficacy and safety of the LM-24C5 in combination with other therapies in subjects with CEACAM5-positive advanced solid tumor

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
30mo left

Started Dec 2025

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Oct 2028

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2028

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

December 2, 2025

Last Update Submit

January 27, 2026

Conditions

Advanced Solid Tumor Cancer

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective response rate

    110weeks

Secondary Outcomes (16)

  • Anti-tumor Activity

    110weeks

  • PK Parameter（AUClast）

    baseline and 110 weeks

  • Immunogenicity of LM-24C5

    baseline and 110 weeks

  • Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy.

    baseline and 110 weeks

  • PK Parameter（AUCtau）

    baseline and 110 weeks

  • +11 more secondary outcomes

Study Arms (2)

LM-24C5 in combination with anti-tumor therapies

EXPERIMENTAL
Drug: LM-24C5

LM-24C5 in combination with other anti-tumor therapies

EXPERIMENTAL
Drug: LM-24C5

Interventions

LM-24C5DRUG

Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug: Docetaxel Q3W Administered intravenously

LM-24C5 in combination with anti-tumor therapies

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • CEACAM5-positive subjects.
  • At least one evaluable lesion.
  • Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose.
  • Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.

You may not qualify if:

  • Subjects with a history of other malignancies within 5 years prior to first dosing of LM-24C5, excluding cured squamous cell carcinoma of the skin, basal cell carcinoma, non-muscle-invasive bladder cancer, or localized low-risk prostate cancer, carcinoma in situ of the cervix/breast, and other malignancies deemed by the investigator to potentially benefit from participation in this study.
  • Subjects who have received other anti-tumor treatments before the first dosing of LM-24C5.
  • Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis.
  • Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
  • Present peripheral sensory or motor neuropathy ≥ grade 2.
  • Subjects with uncontrolled pain.
  • Subjects with symptomatic and untreated central nervous system metastases, and/or meningeal metastases.
  • Subjects who have uncontrollable third space effusion.
  • Previously received targeted therapy for same target.
  • Use of any live vaccines within 28 days prior to 1st dosing of IMP.
  • Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.
  • Subjects on anticoagulants, such as heparin and vitamin K antagonists.
  • Clinically uncontrollable persistent recurrent vomiting.
  • Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.
  • Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of IMP.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

NOT YET RECRUITING

Central Study Contacts

Mengmeng Liu

CONTACT

+8613918118040mengmengliu@lanovamed.com

Paul Kong

CONTACT

+8613564682439paulkong@lanovamed.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2025

First Posted

February 4, 2026

Study Start

December 15, 2025

Primary Completion (Estimated)

May 21, 2028

Study Completion (Estimated)

October 25, 2028

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations

CN(2)