Actively Recruiting
Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-07-08
10
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years.
- Diagnosed with locally advanced or metastatic solid tumors that cannot be surgically removed or treated with radical concurrent chemoradiotherapy.
- Received no more than one line of systemic chemotherapy and one line of systemic PD-1/PD-L1 inhibitor treatment, with treatment failure after at least 6 months and best response of complete or partial remission.
- Have at least one measurable tumor lesion based on RECIST V1.1 criteria.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Expected survival of at least 12 weeks.
- Adequate organ function.
- Patients of reproductive potential must agree to use adequate contraception during and for 6 months after the last infusion.
- Understand and provide written informed consent and agree to follow the study protocol requirements.
You will not qualify if you...
- History of severe hypersensitivity reactions to monoclonal antibodies.
- Untreated, unstable, or uncontrolled central nervous system metastases, except clinically stable cases with no progressive neurological symptoms for at least 4 weeks before treatment.
- Tumor invasion of vital arteries causing high bleeding risk, risk of perforation, or fistula formation.
- Uncontrolled pleural, pericardial, or abdominal effusion.
- Untreated or symptomatic spinal cord compression.
- Previous treatments with immunotherapies such as LAG3, TIGIT, IL-2, IL-15, CD3-like immunoagonists, or cellular therapies.
- Two or more malignant tumors within 5 years before the first dose.
- Immune-related adverse events grade 3 or higher or treatment discontinuation due to immunotherapy.
- Chemotherapy or anti-tumor monoclonal antibody drugs within 4 weeks before first dose; small molecule targeted drugs within 2 weeks; Chinese medicine therapy with anti-tumor indications within 4 weeks.
- Severe infections requiring hospitalization or systemic antibiotics within 4 weeks before first dose.
- Active interstitial lung disease or pneumonia, or history requiring immunosuppressive treatment.
- Serious cardiovascular disease.
- Active bleeding disorders within 6 months before enrollment.
- Active hepatitis B, hepatitis C, syphilis, or active tuberculosis infection.
- Active or previous autoimmune diseases with risk of recurrence.
- Immunodeficiency diseases or positive HIV test.
- Arterial or venous thrombotic events within 6 months before first dose.
- Recent radical or palliative radiation therapy within 4 weeks or 14 days respectively before first dose.
- Use of live or attenuated vaccines within 4 weeks before first dose or anticipated need during study.
- Major surgery within 4 weeks before first dose or planned major surgery during study, except diagnostic procedures.
- Unresolved adverse effects from prior antitumor therapy worse than grade 1.
- Previous allogeneic bone marrow, hematopoietic stem cell, or solid organ transplant.
- Pregnant or lactating women.
- Other serious systemic diseases or conditions making participation unsafe as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
N
Ning Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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