Phase II Clinical Study of LTC004 in Patients With mCRC

NCT06384235 | Not Yet Recruiting Phase 1

• 1 other identifier: LTC004-203
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Locally Advanced or Metastatic CRC

Outcome Measures

Primary Outcomes (1)

• ORR

  Antitumor efficacy of LTC004 treated CRC patients

  up to 12 months

Secondary Outcomes (3)

• DOR

  up to 12 months

• PFS

  up to 12 months

• OS

  up to 12 months

Study Arms (2)

PHASE 1

EXPERIMENTAL

Enrollment of 10 consecutive evaluable CRC 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 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.
• Non-radical resectable metastatic colorectal cancer confirmed by histology or cytology (pathology report required).
• Those who have progressed on, or are intolerant to, at least three lines of prior systemic antitumor therapy for metastatic colorectal cancer. Patients must have received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, as well as patients with mCRC who have received or are not candidates for prior anti-VEGF therapy, TKI agents, and anti-epidermal growth factor receptor therapy (RAS wild-type).
• 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.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.
• Tumor invasion of vital arteries resulting in high risk of bleeding, significant risk of perforation or already formed fistulae.
• Patients with uncontrolled pleural effusion, pericardial effusion or abdominal effusion as judged by the investigator at screening.
• Patients with untreated or clinically symptomatic spinal cord compression that has not been controlled.
• Previous antitumor regimens include immunotherapy such as PD-1/L1 inhibitors, LAG3, TIGIT, IL-2, IL-15, CD3-like immunoagonists, and other cellular therapies.
• ≥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 bleeding disorders, including gastrointestinal bleeding, as evidenced by vomiting of blood, profuse hemoptysis, or black stools, have occurred in the 6 months prior to enrollment.
• 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.

Sponsors & Collaborators

• Letolab: lead

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 25, 2024
• Primary Completion: August 23, 2025
• Study Completion: August 23, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share