Loading clinical trials...

Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas

A Phase 1/2a, Dose-escalation Study of FF-10502-01 for the Treatment of Advanced Solid Tumors and Lymphomas

NCT02661542•Fujifilm Pharmaceuticals U.S.A., Inc.

Summary

A Phase 1/2a, dose-escalation study of FF-10502-01 in Patients with Advanced Solid Tumors and Lymphomas. A total of up to 9 cohorts will be enrolled in Phase 1 to establish the MTD. Phase 2 will consist of 2 cohorts: Cohort 1 will include subjects with Pancreatic Cancer. Cohort 2 will include subjects with another tumor type enrolled in the Phase 1 dose-escalation phase who have demonstrated Clinical Benefit by Week 16.

Detailed Description

Subjects will receive doses of FF-10502-01 intravenously (IV) weekly for three weeks, repeated every 28 days (= 1 cycle). Disease assessments, based on computed tomography (CT), magnetic resonance image (MRI), and, for lymphoma, \[18F\]-fluorodeoxyglucose positron emission tomography (FDG-PET) scans, will be obtained at Week 8 and every 8 weeks thereafter until documented progression of disease (PD). Subjects who demonstrate clinical benefit will be allowed to continue therapy with FF-10502-01 until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in the subject's condition that prevents further study participation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females ≥ 18 years of age
•Histologically or cytologically confirmed advanced or metastatic solid tumor or l lymphoma, that is refractory to standard therapy, relapsed after standard therapy, or for which no standard therapy available that is expected to improve survival by at least three months
•At least 4 weeks beyond the last chemotherapy (or ≥ 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1)
•Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
•Life expectancy of ≥ 3 months
•Adequate hematologic parameters without ongoing transfusional support:
•Hemoglobin (Hb) ≥ 9 g/dL
•Absolute neutrophil count (ANC) ≥ 1.0 x 109 cells/L
•Platelets ≥ 100 x 109 cells/L
•Adequate renal and hepatic function:
+6 more criteria

Exclusion Criteria

•Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV
•Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
•Active central nervous system (CNS) malignant disease in subjects with a history of CNS malignancy. Subjects with stable, prior or currently treated brain metastases are allowed.
•Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
•Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment
•Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
•Pregnant or breast-feeding

Locations (2)

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

January 1, 2016

Primary Completion Date

November 5, 2020

Completion Date

November 5, 2020

Last Updated

April 13, 2022

Enrollment

ACTUAL participants

Conditions

Solid TumorsLymphomas

Interventions

FF-10502-01

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

View study

RECRUITINGNA

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

NCT06658951

HER2-positive Advanced Malignant Solid Tumors

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

A Study of ASP1002 in Adults for Treatment of Solid Tumors

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors