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Unresectable or Metastatic SarcomaPhase 1/2NCT06384248

Phase II Clinical Study of LTC004 in Patients With Advanced Sarcoma

A Phase 1/2 study testing LTC004 in people with Unresectable or Metastatic Sarcoma, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in patients with locally advanced or metastatic sarcoma；Enrollment of 10 evaluable subjects in Phase I. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Unresectable or Metastatic Sarcoma
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
30 participants
Where
No sites listed yet
Study dates
26 Apr 2024to 28 Dec 2025
Phase
Phase 1/2
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

  • Aged 18 to 75 years；
  • Subjects with histologically or cytologically confirmed non-surgically treatable and failed standard therapy recommended by existing clinical standards of care or guidelines at screening (PD during treatment or PD after final treatment), or locally advanced or metastatic sarcoma that cannot tolerate standard therapy and/or for which there is currently no effective standard therapy (if recurrence or metastasis occurs during adjuvant therapy or within 6 months of completion, adjuvant therapy is considered a first-line treatment failure). Note: Embryonal rhabdomyosarcoma, follicular rhabdomyosarcoma, Ewing's sarcoma/primitive neuroectodermal tumor, gastrointestinal mesenchymal tumors, and malignant mesothelioma should be excluded.
  • At least one measurable tumor lesion based on RECIST V1.1 criteria；
  • ECOG PS ≤1；
  • Expected survival ≥12 weeks；
  • Adequate organ function；
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  • 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.
  • 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；
  • 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 and no progressive or uncontrolled neurologic symptoms or signs for at least 4 weeks prior to the first study treatment;
  • Patients with untreated or clinically symptomatic spinal cord compression that has not been controlled.
  • Patients with uncontrolled pleural effusion, pericardial effusion or abdominal effusion as judged by the investigator at screening;
  • Previous immunotherapy, including IL-2, IL-15, PD-1/L1 inhibitors, NK, and TCR-T cell therapy.
  • ≥2 malignant tumors within 5 years prior to first dose of drug；
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  • Moderate to severe dyspnea at rest, severe primary lung disease, current need 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 prior antineoplastic therapy；
  • Presence of severe infection within 4 weeks prior to first dose of medication，Presence of active infection requiring systemic antibiotic therapy with CTCAE grade ≥2 within 2 weeks prior to first dose
  • History of serious cardiovascular disease；
  • Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;
  • Patients with active, or previous autoimmune disease with potential for recurrence;
  • Immunodeficiency diseases or history of such diseases, including a positive serologic test for human immunodeficiency virus (HIV)
  • Arterial/venous thrombotic events within 6 months prior to the first dose of the drug;
  • Those who received radical radiation therapy within 4 weeks prior to the first dose and those who received palliative radiation within 14 days prior to the first dose.
  • Received other unlisted clinical investigational drug or treatment within 4 weeks prior to 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 period；
  • Major surgery (other than surgery for diagnostic purposes) within 4 weeks prior to the first dose, anticipation of major surgery (other than surgery for diagnostic purposes) during the study period, or diagnostic or low-invasive surgery within 7 days prior to the first dose (excluded for puncture biopsies).
  • Tumor invasion into peripheral vital organs (e.g., aorta and trachea) or risk of esophageal-tracheal fistula or esophageal-pleural fistula; history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the drug；
  • Adverse effects of prior antitumor therapy have not recovered to CTCAE version 5.0 grade rating ≤1；
  • Patients who have received a previous allogeneic bone marrow/hematopoietic stem cell transplant or solid organ transplant；
  • Pregnant and lactating women；
  • Subjects who in the judgment of the investigator, have a history of other serious systemic disease or are unfit to participate in this trial for any other reason (the presence of psychiatric disorders in the patient that may affect compliance with the trial, alcohol, drug or substance abuse, etc.)

About this study

Official title: An Open, Single-Arm, Phase II Clinical Study Evaluating the Efficacy and Safety of LTC004 Alone in Patients With Locally Advanced or Metastatic Sarcoma Who Have Failed Standard Treatment

This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in patients with locally advanced or metastatic sarcoma；Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission or SD lasting >12 weeks, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004

Being tested
LTC004
Medical subject headings
Sarcoma

What participants receive

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

  • LTC004Drug

    LTC004,45μg/kg,IV,Day 1,Q3W;

Study groups in NCT06384248
Study groupRoleWhat they receive
PHASE 1ExperimentalEnrollment of 10 consecutive evaluable sarcoma subjects with failure of existing standard therapy or lack of effective treatment Treated with LTC004 in Phase I
Receives: Drug: LTC004
PHASE 2ExperimentalIf ≥2 subjects experience objective remission or SD lasting >12 weeks in PHASE 1, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004
Receives: Drug: LTC004

What is being measured

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

  1. ORR

    Antitumor efficacy of LTC004 treated sarcoma patients

    Measured: up to 12 months

Secondary outcomes (3)

  1. DOR

    Duration of Response of LTC004 treated sarcoma patients

    Measured: up to 12 months

  2. PFS rate

    12 weeks and 24 weeks Progression-Free Survival rate of LTC004 treated sarcoma patients

    Measured: up to 12 months

  3. OS

    Overall Survival of LTC004 treated sarcoma patients

    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 posted25 Apr 2024
  2. Study start26 Apr 2024 (estimated)
  3. Primary completion28 Dec 2025 (estimated)
  4. Study completion28 Dec 2025 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06384248
Sponsor's protocol ID
LTC004-205
Status last verified
Apr 2024
First submitted
22 Apr 2024
Last updated
25 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LTC004 in people with Unresectable or Metastatic Sarcoma, 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 25 Apr 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 combined 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.

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?

Results are not available in the source record.

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?

ORR (time frame: up to 12 months). 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 NCT06384248.

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 25 Apr 2024.

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