Solid TumorEarly Phase 1NCT06695689
An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours
A Early Phase 1 study testing LM303 in people with Solid Tumor, run by Suzhou BlueHorse Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM303 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- LM303
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2024to Oct 2027
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment;
- The patient has residual lesions that can be used for surgical resection (>1.5cm3) or biopsy (>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation;
- Laboratory inspection index requirements:
- Blood routine: lymphocyte ratio > 20%; neutrophil count > 1.0 × 10^9/L; white blood cells > 3.0 × 10^9/L; platelets > 100 × 10^9/L; hemoglobin > 80 g/ L;
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (ALP) ≤ upper limit of normal x 2.5; total gallbladder Red pigment (TBIL)≤normal upper limit×1.5;
- Renal function: urea ≤ upper limit of normal × 1.5; creatinine (Cr) ≤ upper limit of normal × 1.5;
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- Left ventricular ejection fraction (LVEF) ≥ 50%;
- ECOG physical condition is 0 or 1;
- The expected survival time is more than 3 months;
Who cannot join
- Suffering from active or previous autoimmune diseases ;
- Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
- Combined with severe infection or persistent infection and cannot be effectively controlled;
- Central nervous system metastasis and/or cancerous meningitis;
- With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Requires systemic steroid therapy;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb); positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Beichen Hospital
Tianjin, 300000
Li Feng'e, 13821072072, rosetea85@163.com
About this study
This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM303 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.
- Conditions
- Solid Tumor
- Being tested
- LM303
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM303Drug
Treatment with LM303 injection
| Study group | Role | What they receive |
|---|---|---|
| LM303 | Experimental | Treatment with LM303 injection Receives: Drug: LM303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: Up to 1 years
Secondary outcomes (4)
Number of Participants With Objective Response
Participants displaying objective response associated with the treatment regimen per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Measured: Up to 2 years
Disease Control Rate (DCR）
Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1
Measured: Up to 2 years
Progression-Free Survival (PFS)
The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
Measured: Up to 2 years
The changes of the immunoreactivity during treatment
The changes from baseline of systemic immune Response markers: peripheral blood lymphocyte subtypes counts, cytokine, antigen-specific T-lymphocytes
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start17 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou BlueHorse Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695689
- Sponsor's protocol ID
- LM303-CO-301
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT06695689
- Acronym / sponsor ID
- LM303-CO-301
- Conditions
- Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Suzhou BlueHorse Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Nov 2024 (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 is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM303 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LM303 | Experimental | Drug: LM303Treatment with LM303 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment;
- The patient has residual lesions that can be used for surgical resection (>1.5cm3) or biopsy (>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation;
- Laboratory inspection index requirements:
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- ECOG physical condition is 0 or 1;
Key exclusion criteria (7 listed)
- Suffering from active or previous autoimmune diseases ;
- Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
- Combined with severe infection or persistent infection and cannot be effectively controlled;
- Central nervous system metastasis and/or cancerous meningitis;
- With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
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 |
|---|---|---|
| LM303Treatment with LM303 injection | Drug | LM303 |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Up to 1 years
Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
4 secondary outcomes
Number of Participants With Objective Response
Time frame: Up to 2 years
Disease Control Rate (DCR）
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
The changes of the immunoreactivity during treatment
Time frame: Up to 2 years
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 19 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LM303 in people with Solid Tumor, run by Suzhou BlueHorse Therapeutics Co., Ltd. at 1 site 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 7 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Feng e Li (13821072072, rosetea85@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Up to 1 years). 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 19 Nov 2024.