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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

LTC004 in Combination With Cyclophosphamide and Fludarabine
Drug
LTC004 was given on day 1 and cyclophosphamide (250 mg/m2) in combination with fludarabine (25 mg/m2) was given on days 3 and 4 of each cycle, Q3W, until disease progression, withdrawn informed or intolerable

Treatment groups

48 Participants

are divided into 2 treatment groups

Group A: Dose-escalation phaseExperimental treatment 1 intervention

Group B: Dose-expansion phaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety, tolerability and antitumor efficacy of Combination.

Dose-limiting toxicity (DLT) Incidence;TEAE and SAE Incidence，Changes in safety indicators before and after administration

Time frame

up to 12 months

Secondary outcomes

PK Characteristics and immunogenicity of Combination

Serum concentration and antibody positivity of LTC004

Time frame

up to 12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Letolab

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: