Advanced Solid Tumor CancerPhase 2NCT07387081
Phase II Study of LM-24C5
A Phase 2 study testing LM-24C5 in people with Advanced Solid Tumor Cancer, run by LaNova Medicines Limited at 2 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumor Cancer
- What is being tested?
- LM-24C5
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesChina
- Study dates
- 15 Dec 2025to 25 Oct 2028
- Phase
- Phase 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.
- CEACAM5-positive subjects.
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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.
- Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.
Who cannot join
- 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.
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- 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.
- Subjects who have severe cardiovascular disease.
- Subjects who have uncontrolled or severe illness.
- Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP.
- Subjects with a known history of autoimmune diseases.
- Subjects who have a history of immunodeficiency disease.
- Subjects with HIV infection, active HBV or HCV infection.
- Child-bearing potential female who have positive results in pregnancy. test within 7 days before the first dose 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Rongbo Lin
- Not yet recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Caicun Zhou
About this study
Official title: An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of LM-24C5 in Combination With Other Anti-tumor Treatment in Subjects With CEACAM5-positive Advanced Solid Tumors
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
- Conditions
- Advanced Solid Tumor Cancer
- Being tested
- LM-24C5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-24C5Drug
Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug: Docetaxel Q3W Administered intravenously
LM-24C5Drug
Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug:Trifluridine and Tipiracil Hydrochloride Tablets BID,Oral Administration Drug:Bevacizumab Injection Q2W Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| LM-24C5 in combination with anti-tumor therapies | Experimental | Not described Receives: Drug: LM-24C5 |
| LM-24C5 in combination with other anti-tumor therapies | Experimental | Not described Receives: Drug: LM-24C5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 110weeks
Secondary outcomes (16)
Anti-tumor Activity
Based on RECIST v1.1, evaluated progression-free survival (PFS), duration of response (DOR), disease control rate (DCR = CR + PR + SD), and change in target lesions relative to baseline; overall survival (OS).
Measured: 110weeks
PK Parameter（AUClast）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
Immunogenicity of LM-24C5
ADA、Nab
Measured: baseline and 110 weeks
Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy.
Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy.
Measured: baseline and 110 weeks
PK Parameter（AUCtau）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（Cmax）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（Tmax）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（T1/2）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（ss）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（Cmin）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（CLss）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（Vss）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（Rac）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（AUC）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（Cmax）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
PK Parameter（DF）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Rac, Cmax, DF, etc.
Measured: baseline and 110 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start15 Dec 2025
- Primary completion21 May 2028 (estimated)
- Study completion25 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 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
- NCT07387081
- Sponsor's protocol ID
- LM24C5-02-201
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of LM-24C5 in Combination With Other Anti-tumor Treatment in Subjects With CEACAM5-positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07387081
- Acronym / sponsor ID
- LM24C5-02-201
- Conditions
- Advanced Solid Tumor Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- LaNova Medicines LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 21 May 2028 (estimated)
- Study completion
- 25 Oct 2028 (estimated)
- First posted
- 4 Feb 2026 (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 evaluate the efficacy and safety of the LM-24C5 in combination with other therapies in subjects with CEACAM5-positive advanced solid tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 (24 listed)
- 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.
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-24C5Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug: Docetaxel Q3W Administered intravenously | Drug | LM-24C5 in combination with anti-tumor therapies |
| LM-24C5Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug:Trifluridine and Tipiracil Hydrochloride Tablets BID,Oral Administration Drug:Bevacizumab Injection Q2W Administered intravenously | Drug | LM-24C5 in combination with other anti-tumor therapies |
Primary outcome
ORR
Time frame: 110weeks
Objective response rate
16 secondary outcomes
Anti-tumor Activity
Time frame: 110weeks
PK Parameter（AUClast）
Time frame: baseline and 110 weeks
Immunogenicity of LM-24C5
Time frame: baseline and 110 weeks
Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy.
Time frame: baseline and 110 weeks
PK Parameter（AUCtau）
Time frame: baseline and 110 weeks
PK Parameter（Cmax）
Time frame: baseline and 110 weeks
PK Parameter（Tmax）
Time frame: baseline and 110 weeks
PK Parameter（T1/2）
Time frame: baseline and 110 weeks
PK Parameter（ss）
Time frame: baseline and 110 weeks
PK Parameter（Cmin）
Time frame: baseline and 110 weeks
PK Parameter（CLss）
Time frame: baseline and 110 weeks
PK Parameter（Vss）
Time frame: baseline and 110 weeks
PK Parameter（Rac）
Time frame: baseline and 110 weeks
PK Parameter（AUC）
Time frame: baseline and 110 weeks
PK Parameter（Cmax）
Time frame: baseline and 110 weeks
PK Parameter（DF）
Time frame: baseline and 110 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 4 Feb 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LM-24C5 in people with Advanced Solid Tumor Cancer, run by LaNova Medicines Limited at 2 sites 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 9 inclusion and 24 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
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 Mengmeng Liu (+8613918118040, mengmengliu@lanovamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 110weeks). 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 4 Feb 2026.