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Adult Solid TumorPhase 1NCT05666635

Study of LTC004 in Subjects With Advanced Malignant Tumors

A Phase 1 study testing LTC004 in people with Adult Solid Tumor, run by Letolab.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This was a multicenter, open, multi-cohort PHASE I study, consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib multi-cohort expansion). The objective of this study was to evaluate safety, tolerability, pharmacokinetic， Pharmacodynamics and biological characteristics, and initial efficacy… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Adult Solid Tumor
What is being tested?
LTC004
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
No sites listed yet
Study dates
Dec 2022to Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged 18 to 75 years (including upper and lower limit) at the time of signing the informed consent form (ICF)；
  • Subjects with locally advanced or metastatic solid tumors or lymphoma who have histologically or cytologically confirmed inoperable disease at screening and have failed from standard treatment，or cannot tolerate standard treatment and/or currently have no effective standard treatment；
  • Patients must have at least 1 lesion that qualifies as a target lesion；
  • ECOG≤1；
  • Life expectancy ≥3 months；
  • Adequate organ function；
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  • Patients who have received any chemotherapy or anti-tumor monoclonal antibody drugs within 4 weeks prior to the first dose of study drug (excluding mitomycin and nitrosoureas within 6 weeks prior to the first dose of study drug）; small molecule targeted drugs within 2 weeks prior to the first dose of study drug; Chinese medicine therapy (Chinese medicine therapy with clear anti-tumor indications in the package insert ）within 4 weeks prior to the first dose of study drug；
  • Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for 6 months after the last infusion of LTC004.
  • Understands and provides written informed consent and willing to follow the requirements specified in protocol

Who cannot join

  • History of severe hypersensitivity reactions to other mAbs.
  • Untreated, unstable or uncontrolled central nervous system (CNS) metastases with following exceptions:A. Clinically stable MRI scans (at least 2 consecutive scans within prior 6 months including 1 scan within 28 days prior to screening) and no progressive or uncontrolled neurologic symptoms or signs (e.g., seizures, headaches, central nausea/emesis, progressive neurologic deficits, papilledema) for at least 4 weeks prior to the first study treatment;
  • Patients with uncontrolled pleural effusion, pericardial effusion or abdominal effusion (requiring repeated drainage, more than one month or more frequently) as judged by the investigator at screening;
  • Patients with untreated or clinically uncontrolled spinal cord compression (except for those who have been treated and have stable symptoms and image for at least 4 weeks before the first dose, and no evidence of cerebral edema, and no need for glucocorticoid therapy);
  • Concurrent malignancy within 5 years prior to entry, except for adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma;
  • Moderate to severe dyspnea at rest, severe primary lung disease required for continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or pneumonia due to advanced cancer or its complications; ≥ Grade 3 interstitial pneumonia during previous anti-tumor treatment;
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  • History of moderate to severe dyspnea at rest due to advanced cancer or their complications, severe primary lung disease, current need of continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or pneumonitis.
  • Severe infection within 4 weeks before the first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; active infection with CTCAE ≥ grade 2 requiring systemic antibiotics within 2 weeks before the first dose；
  • History of serious cardiovascular and cerebrovascular diseases, including but not limited to: severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 and above cardiovascular and cerebrovascular events within 6 months before the first dose; New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) < 50% or clinically uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
  • Patients who have any known liver disease, including chronic hepatitis B (HBsAg positive and HBV DNA ≥ ULN of local site and excluding hepatitis caused by drugs or other reasons), hepatitis C, autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis; Patients who have concurrent, serious, uncontrolled infections or known infection with HIV, or have a diagnosed acquired immunodeficiency syndrome (AIDS); or an uncontrolled autoimmune disease, or have undergone organ transplant；
  • Syphilis positive patients at screening；
  • Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) at screening, or have suffered from autoimmune diseases that may relapse, except for patients with clinically stable autoimmune thyroid disease；
  • History of immunodeficiency disease , including positive human immunodeficiency virus (HIV) serum test；
  • Patients who have experienced bleeding symptoms of significant clinical significance within 3 months before the first dose; Subjects who had a significant cough of blood and hemoptysis of half a teaspoon (2.5 mL) or more per occasion within 4 weeks prior to the first dose of study drug; arterial/venous thrombotic events such as cerebrovascular accident, deep venous thrombosis, pulmonary embolism within 6 months prior to the first dose; and those who were receiving anticoagulant therapy at screening；
  • Patients who have received systemic immunosuppressive therapy (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, etc.) within 2 weeks before the first dose；
  • Immunomodulatory drugs within 2 weeks (or 5 drug half-lives, whichever is longer) before the first dose, including but not limited to thymosin, IL-2, IL-15, interferon, etc.
  • Receiving non-thoracic radical radiotherapy > 30 Gy within 4 weeks before the first dose, thoracic radiotherapy > 30 Gy within 24 weeks before the first dose, and palliative radiotherapy ≤ 30 Gy within 14 days before the first dose.
  • Received other unmarketed clinical study drugs or treatments within 4 weeks before the first dose.
  • Use of live or attenuated vaccines within 4 weeks prior to the first dose, or anticipated need for live or attenuated vaccines during the study.
  • 20:Received major surgery within 4 weeks prior to the first dose (except for procedures for diagnostic purposes), anticipated major surgery during the study (except for procedures for diagnostic purposes), or diagnostic or less invasive surgery within 7 days prior to the first dose (not in this range for needle biopsy).
  • 21：Have not recovered from previous anti-tumor treatment， CTCAE 5.0 grade evaluation ≤ 1 (alopecia and grade 2 neurotoxicity caused by chemotherapeutic drugs, as well as grade 2 hypothyroidism caused by anti-tumor treatment); 22：Patients who have previously received allogeneic bone marrow/hematopoietic stem cell transplantation or solid organ transplantation.
  • 23：Pregnant and lactating women. 24：The subjects have a history of other serious systemic diseases or any other reason (patients with mental illness, alcoholism, drug abuse or drug abuse that may affect the compliance of the trial) should not participate in this trial as judged by investigator.

Trial locations and contacts

No sites are listed yet.

Jinying Zhou contact

+8618911370622

zhoujinying@letolab.net

About this study

Official title: A Phase I Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LTC004 in Patients With Advanced or Metastatic Malignancies

This was a multicenter, open, multi-cohort PHASE I study, consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib multi-cohort expansion). The objective of this study was to evaluate safety, tolerability, pharmacokinetic， Pharmacodynamics and biological characteristics, and initial efficacy in advanced malignant tumors.

Read the detailed description

Phase I dose escalation phase：This study predicted a total of 8 dose groups, 3, 15, 45, 90, 180，270，360 and 450 ug/kg.

Phase Ib expansion phase: This phase is the multi-cohort indication expansion phase. Based on the data obtained in phase I, chose an appropriate dose continue to explore multi-cohort indications.

Being tested
LTC004

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LTC004Biological

    LTC004 Phase I:Participants will be allocated to one of the following dose groups: 3, 15, 45, 90, 180，270,360 and 450 ug/kg, and receive a treatment of LTC004 followed by 21 days of dose limited toxicity (DLT) observation period.

    Phase Ib indication exploration

    Other Name: LTC004 for Injection

Study groups in NCT05666635
Study groupRoleWhat they receive
Experimental：LTC004ExperimentalMonotherapy, dose escalation
Receives: Biological: LTC004

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Event (AE)

    safety and tolerability as measured by the incidence of treatment-emergent adverse events.

    Measured: up to 12 months

  2. Number of participants with DLTs

    DLTs as measured by the incidence during Cycle 1.

    Measured: up to 21 days

Secondary outcomes (4)

  1. Objective response rate (ORR)

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

    Measured: up to 12 months

  2. Serum concentrations of LTC004

    Concentration data will be summarized by dose level

    Measured: up to 12 months

  3. Immunogenicity of LTC004

    Results will be summarized by dose level

    Measured: up to 12 months

  4. Serum concentrations of cytokines and T cell

    including IFNγ, TNF-α, IL-1B, IL-6, IL-10，total T cells, CD8+ T cells, NK cells and Treg cells

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study startDec 2022 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
Sequential
Model description
Participants will be assigned to sequentially escalating dose cohorts of LTC004
Masking
None (open label)
Enrolment
368 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05666635
Sponsor's protocol ID
LTC004-101
Status last verified
Dec 2022
First submitted
10 Nov 2022
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LTC004 in people with Adult Solid Tumor, run by Letolab.

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 22 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: status not confirmed, as of the sponsor's last update on 28 Dec 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jinying Zhou (+8618911370622, zhoujinying@letolab.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Event (AE) (time frame: up to 12 months). 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?

On the ClinicalTrials.gov record for NCT05666635.

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 28 Dec 2022.

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