Advanced Malignant TumorsPhase 1NCT06226363
Phase I Study of LNF1901 in Advanced Malignant Tumors
A Phase 1 study testing LNF1901 Monoclonal Antibody Injection in people with Advanced Malignant Tumors, run by Shandong New Time Pharmaceutical Co., LTD.
Trial summary
This is a multicenter, open, phase I dose-escalation and dose-expansion study to evaluate the safety, tolerability, initial antitumor efficacy, PK and immunogenic characteristics of LNF1901 in patients with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- LNF1901 Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Feb 2027
- Phase
- 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
- Male or female ≥18 years of age;
- Patients with advanced malignant tumors who have been confirmed histologically or cytologically and have failed to receive standard therapy, or cannot tolerate standard therapy, or cannot receive standard therapy for other reasons;
- Participants enrolled in the dose expansion phase had at least one measurable lesion; (4) Those who adopted the United States Eastern Oncology Consortium (ECOG) physical status score of 0~1;
- 5) The researchers judged that the expected life of the subjects was ≥3 months; 6) The function of vital organs meets the following requirements (drugs with blood components and cytokines are not allowed to be used within 14 days before the first administration) : Blood routine: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥80×109/L; Hemoglobin (Hb) ≥90g/L; Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN, serum total bilirubin (TBIL) ≤1.5×ULN; If liver metastasis exists, AST and ALT≤5×ULN, TBIL≤1.5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50mL/min (Cr > 1.5×ULN); Coagulation function: International Normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN; Thyroid function: Thyroid stimulating hormone (TSH) within the normal range or free triiodothyronine (FT3), free thyroxine (FT4) normal or abnormal without clinical significance; 7) Subjects voluntarily participate in the study and sign the informed consent after receiving full informed consent.
Who cannot join
- Those who have previously received antibody treatment with any tumor necrosis factor receptor (TNFR) superfamily agonists, such as CD40, OX40, CD137, CD27, CD357, etc.;
- Those who have received anti-tumor therapy 4 weeks before the first administration or within 5 half-lives of the drug (whichever is shorter);
- Chronic systemic glucocorticoid therapy within 2 weeks prior to initial administration (daily dose equivalent to prednisone \> 10mg of systemic corticosteroids) or any other form of immunosuppressive therapy;
- The toxicity of previous anti-tumor therapy has not returned to CTCAE5.0 version of the definition ≤ Class 1 (except hair loss);
- A history of cancer within the past 5 years, except for locally curable cancers (radical melanoma, basal or squamous cell carcinoma, carcinoma in situ of the bladder or cervix);
- Patients with primary central nervous system (CNS) malignancies, CNS metastases after local treatment failure, and cancerous meningitis; Patients with asymptomatic brain metastases or stable neurological symptoms without steroid hormones or other BMS for ≥4 weeks could be enrolled.
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- Patients with a history of organ transplantation or allogeneic bone marrow transplantation or who have received autologous stem cell transplantation within 3 months before the first administration of the drug;
- Those who have undergone major surgery or have not recovered from surgery within 4 weeks prior to the first dosing (except for diagnostic surgery);
- Physical examination or laboratory examination, any of the following conditions:
- Hepatitis B: HBsAg positive and/or HBcAb positive with HBV-DNA titers positive or higher than the upper limit of normal (excluded if only the lower limit of detection is present); Hepatitis C: HCV antibody positive and HCV-RNA positive or greater than the upper limit of normal; Human immunodeficiency virus (Anti-HIV) positive; active treponema pallidum infection;
- Uncontrolled or severe cardiovascular disease, such as New York Heart Association (NYHA) Class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular disease, poorly controlled arrhythmias, within 6 months before the first administration of the drug. Difficult to control hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg after adequate treatment);
- Patients with a history of the following, including but not limited to active autoimmune diseases, active infections (such as active tuberculosis), severe mental illness, and severe endocrine disorders;
- Patients who have been treated with any other investigational drug/device within 4 weeks prior to initial administration;
- Have a history of drug abuse or alcoholism within 6 months before the first dose;
- Have a history of severe allergy, and known subjects are previously allergic to macromolecular protein preparations/monoclonal antibodies and to any investigational drug components;
- Those who received live or attenuated vaccine within 4 weeks before the first dose or planned to receive live or attenuated vaccine during the study period;
- Pregnant or lactating women, female subjects of childbearing age, or male subjects whose partners are women of childbearing age who do not consent to the use of medically approved effective contraceptive methods (such as Iuds or condoms) during the study period and within 6 months after the last study drug treatment;
- Those who were judged not suitable for inclusion by the researchers.
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of LNF1901 in Advanced Malignant Tumors
This is a multicenter, open, phase I dose-escalation and dose-expansion study to evaluate the safety, tolerability, initial antitumor efficacy, PK and immunogenic characteristics of LNF1901 in patients with advanced malignancies.
- Conditions
- Advanced Malignant Tumors
- Being tested
- LNF1901 Monoclonal Antibody Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNF1901 Monoclonal Antibody InjectionDrug
LNF1901，7 dose groups:0.003mg/kg、0.03mg/kg、0.1mg/kg、0.3mg/kg、1mg/kg、2mg/kg、3mg/kg，IV, infusion time 60min±10min, Q3W, until disease progression or other reasons to stop treatment, the longest administration to 2 years, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| LNF1901 monotherapy | Experimental | Not described Receives: Drug: LNF1901 Monoclonal Antibody Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities
DLTs will include Grade 4 neutropenia, anemia, thrombocytopenia, Grade 4 cytokine release syndrome and other Grade 3 non-hematological toxicity etc
Measured: Up to 21 days following first dose of APX005M
Incidence of adverse events
Incidence and severity of AEs and specific laboratory abnormalities graded according to NCI-CTCAE, v5.0
Measured: Through up to approximately 30 days following last dose of LNF1901
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226363
- Sponsor's protocol ID
- NTP-LNF1901-001
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of LNF1901 in Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT06226363
- Acronym / sponsor ID
- NTP-LNF1901-001
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Jan 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 multicenter, open, phase I dose-escalation and dose-expansion study to evaluate the safety, tolerability, initial antitumor efficacy, PK and immunogenic characteristics of LNF1901 in patients with advanced malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LNF1901 monotherapy | Experimental | Drug: LNF1901 Monoclonal Antibody Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥18 years of age;
- Patients with advanced malignant tumors who have been confirmed histologically or cytologically and have failed to receive standard therapy, or cannot tolerate standard therapy, or cannot receive standard therapy for other reasons;
- Participants enrolled in the dose expansion phase had at least one measurable lesion; (4) Those who adopted the United States Eastern Oncology Consortium (ECOG) physical status score of 0~1;
- 5) The researchers judged that the expected life of the subjects was ≥3 months; 6) The function of vital organs meets the following requirements (drugs with blood components and cytokines are not allowed to be used within 14 days before the first administration) : Blood routine: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥80×109/L; Hemoglobin (Hb) ≥90g/L; Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN, serum total bilirubin (TBIL) ≤1.5×ULN; If liver metastasis exists, AST and ALT≤5×ULN, TBIL≤1.5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50mL/min (Cr > 1.5×ULN); Coagulation function: International Normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN; Thyroid function: Thyroid stimulating hormone (TSH) within the normal range or free triiodothyronine (FT3), free thyroxine (FT4) normal or abnormal without clinical significance; 7) Subjects voluntarily participate in the study and sign the informed consent after receiving full informed consent.
Key exclusion criteria (18 listed)
- Those who have previously received antibody treatment with any tumor necrosis factor receptor (TNFR) superfamily agonists, such as CD40, OX40, CD137, CD27, CD357, etc.;
- Those who have received anti-tumor therapy 4 weeks before the first administration or within 5 half-lives of the drug (whichever is shorter);
- Chronic systemic glucocorticoid therapy within 2 weeks prior to initial administration (daily dose equivalent to prednisone \> 10mg of systemic corticosteroids) or any other form of immunosuppressive therapy;
- The toxicity of previous anti-tumor therapy has not returned to CTCAE5.0 version of the definition ≤ Class 1 (except hair loss);
- A history of cancer within the past 5 years, except for locally curable cancers (radical melanoma, basal or squamous cell carcinoma, carcinoma in situ of the bladder or cervix);
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 |
|---|---|---|
| LNF1901 Monoclonal Antibody InjectionLNF1901，7 dose groups:0.003mg/kg、0.03mg/kg、0.1mg/kg、0.3mg/kg、1mg/kg、2mg/kg、3mg/kg，IV, infusion time 60min±10min, Q3W, until disease progression or other reasons to stop treatment, the longest administration to 2 years, whichever occurs first. | Drug | LNF1901 monotherapy |
Primary outcome
Incidence of dose limiting toxicities
Time frame: Up to 21 days following first dose of APX005M
DLTs will include Grade 4 neutropenia, anemia, thrombocytopenia, Grade 4 cytokine release syndrome and other Grade 3 non-hematological toxicity etc
Incidence of adverse events
Time frame: Through up to approximately 30 days following last dose of LNF1901
Incidence and severity of AEs and specific laboratory abnormalities graded according to NCI-CTCAE, v5.0
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 26 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LNF1901 Monoclonal Antibody Injection in people with Advanced Malignant Tumors, run by Shandong New Time Pharmaceutical Co., LTD.
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 4 inclusion and 18 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: opening soon, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (time frame: Up to 21 days following first dose of APX005M). The study lists 2 primary outcomes in all. 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 26 Jan 2024.