Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy

NCT06490068 | Recruiting Phase 2

• 1 other identifier: LTC004-204
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of LTC004 in combination with Toripalimab in 10 patients with advanced solid tumors resistant to first-line immunotherapy, all eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• ORR

  Antitumor efficacy of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy

  up to 12 months

Secondary Outcomes (4)

• DCR

  up to 12 months

• DOR

  up to 12 months

• PFS

  up to 12 months

• OS

  up to 12 months

Study Arms (1)

LTC004+Toripalimab

EXPERIMENTAL

Eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab.

Drug: LTC004+Toripalimab

Interventions

LTC004+Toripalimab DRUG

LTC004 on D1 of Week 1 and D1 of week 3. IV,90μg/kg. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab. LTC004:D3,iv,45μg/kg,Q3W. Toripalimab:D1,iv,240mg,Q3W.

Also known as: LTC004 combine with Toripalimab

LTC004+Toripalimab

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.
• 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.
• 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 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.
• irAE with ≥ grade 3 or discontinuation due to immunotherapy in the past.
• 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 with clear anti-tumor indications in the package insert within 4 weeks prior to the first dose of study drug.
• Severe infection, including but not limited to bacteremia requiring hospitalization and severe pneumonia, occurs within 4 weeks prior to the first medication; Active infection of grade CTCAE≥2 requiring treatment with systemic antibiotics was present within 2 weeks prior to the first dose.
• The subject has active interstitial lung disease (ILD) or pneumonia; A history of needing hormones or other immunosuppressants to treat ILD or (non-infectious) pneumonia.
• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• Ning Li, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li

CONTACT

010-87788495; cancergcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: June 4, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)