Status:
RECRUITING
Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Detailed Description
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 progressio...
Eligibility Criteria
Inclusion
- Aged 18 to 75 years.
- Locally advanced or metastatic solid tumors confirmed by pathology or cytology that cannot be surgically resected or can not be treated with radical concurrent chemoratherapy, and immune checkpoint inhibitor ± chemotherapy has become the standard first-line treatment, such as NSCLC, cervical cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, etc. In addition, the patients had received no more than 1 line of systemic chemotherapy and no more than 1 line of systemic PD-1/PD-L1 inhibitor treatment at the same time or successively, and the treatment failed, and the previous PD-1/PD-L1 inhibitor treatment lasted more than 6 months, the best curative effect was CR/PR; No systemic antitumor therapy other than the above treatment was received (Note: if there is a second-line standard treatment, the second-line standard treatment is required to be completed before inclusion in this trial).
- 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.
Exclusion
- 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.
- 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.
- 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 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).
- 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.
Key Trial Info
Start Date :
June 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06490068
Start Date
June 4 2024
End Date
March 31 2026
Last Update
July 8 2024
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China