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This was a multicenter, open PHASE I study of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced/Metastatic Malignancies Tumor, the study design consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib expansion). The objective of this study was to evaluate combination safety, tolerability, pharmacokinetic,pharmacodynamics characteristics, and initial efficacy in advanced malignant tumors.
Enrollment
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Inclusion criteria
Aged 18 to 75 years;
Subjects with a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic solid tumor or lymphoma that is not amenable to surgical treatment at the time of screening and that has failed after standard treatment as recommended by existing clinical standards of care or guidelines or that is not refractory to standard treatment and/or for which there is no currently effective standard of care.
The current open indication population is patients with soft tissue sarcoma, with the following specific requirements:
Histologically/cytologically confirmed diagnosis of unresectable or metastatic soft tissue sarcoma with failure of existing standard therapy or lack of effective treatment, as follows: 1) For pathological subtypes other than adenovascular soft tissue sarcoma and epithelioid sarcoma, failure of, or intolerance to, at least standard chemotherapy regimens of adriamycin or adriamycin in combination with isocyclophosphamide; and 2) For adenovascular soft tissue sarcoma and epithelioid sarcoma. Prior treatment failure or intolerance to a targeted agent [anti-angiogenic class such as amlotinib, pezopanib, etc.] is required; Note: Disease progression <6 months after the end of treatment in neoadjuvant or adjuvant patients is considered first-line treatment;
At least one measurable tumor lesion based on RECIST V1.1 criteria;
ECOG PS ≤1;
Expected survival ≥12 weeks;
Adequate organ function;
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;
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.
Understands and provides written informed consent and willing to follow the requirements specified in protocol.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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48 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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