Phase II Clinical Study of LTC004 in Patients With Advanced Sarcoma

NCT06384248 | Not Yet Recruiting Phase 1

• 1 other identifier: LTC004-205
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Unresectable or Metastatic Sarcoma

Outcome Measures

Primary Outcomes (1)

• ORR

  Antitumor efficacy of LTC004 treated sarcoma patients

  up to 12 months

Secondary Outcomes (3)

• DOR

  up to 12 months

• PFS rate

  up to 12 months

• OS

  up to 12 months

Study Arms (2)

PHASE 1

EXPERIMENTAL

Enrollment of 10 consecutive evaluable sarcoma subjects with failure of existing standard therapy or lack of effective treatment Treated with LTC004 in Phase I

Drug: LTC004

PHASE 2

EXPERIMENTAL

If ≥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

Drug: LTC004

Interventions

LTC004 DRUG

LTC004,45μg/kg,IV,Day 1,Q3W;

PHASE 1; PHASE 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• 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.

You may not qualify if:

• 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；
• 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.

Sponsors & Collaborators

• Letolab: lead

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: April 26, 2024
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share