A Phase I Study of LTC004 Combin With FC in Patients With Advanced/Metastatic Malignancies Tumor
ConditionAdult Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLetolab
About this trial
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.
Eligibility criteria
Qualifiers
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.
At least one measurable tumor lesion based on RECIST V1.1 criteria；
ECOG PS ≤1；
Disqualifiers
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;
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.
Trial design
Treatments tested in this trial
- LTC004 in Combination With Cyclophosphamide and Fludarabine
Treatment groups
48 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov