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

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 Maximum Tolerated Dose (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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors; Lymphomas
• Intervention / Treatment: Drug: FF-10502-01

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Sarah Cannon Research Institute at HealthOne
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:
• Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula
• Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ( ≤ 2.5 times ULN, or < 5 times ULN for subjects with liver metastases
• QT interval corrected for rate (QTc) ≤ 480 msec on the electrocardiogram (ECG) obtained at Screening
• Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment.
• Ability to provide written informed consent

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1, Cohorts 1-9; FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing by cohort: Cohort 1, 8mg/m2; Cohort 2, 12mg/m2; Cohort 3, 18mg/m2, Cohort 4, 27mg/m2; Cohort 5, 40mg/m2; Cohort 6, 60mg/m2; Cohort 7, 90mg/m2; Cohort 8, 135mg/m2; Cohort 9, 100mg/m2.	Drug: FF-10502-01
Experimental: Phase 2a, Cohort 10, Advanced solid tumors; FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.	Drug: FF-10502-01
Experimental: Phase 2a, Cohort 11, Cholangiocarcinoma; FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.	Drug: FF-10502-01
Experimental: Phase 2a, Cohort 12, Gall bladder carcinoma; FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.	Drug: FF-10502-01
Experimental: Phase 2a, Cohort 13, Urothelial carcinoma; FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.	Drug: FF-10502-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Treatment Emergent Adverse Events (TEAE)	Safety and tolerability assessed by number of subjects with adverse events (AEs), and serious adverse events. (SAEs)	Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Overall Response Rates (ORR)	Number of subjects who had overall responses of Partial Response, Stable Disease, Progressive Disease or Not Evaluable	Responses assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug (every 28 days=1 cycle), up to 38 months
Number of Subjects With Objective Response (OR) Events	Number of subjects with objective response events, number of subjects with progressive disease or death events atter objective response and number of subjects censored after objective response	Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Objective Response (OR)	Median duration of objective response in days for each cohort".	Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Stable Disease (SD) Events	Number of subjects with stable disease, number of subjects with progressive disease or death after stable disease and number of subjects censored after stable disease	Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Stable Disease (SD)	Median duration of stable disease (SD) in days for each cohort	Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Progression-free Survival (PFS) Events	Number of subjects with progressive disease or death and number of subject censored.	Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Progression-free Survival (PFS)	This outcome measure shows the median number of days of progression-free survival (PFS) for each cohort	Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Overall Survival (OS) Events	Number of subjects with overall survival (OS) events in each cohort	Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Overall Survival (OS)	Median number of days of overall survival (OS) for each cohort	Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months

Collaborators and Investigators

• Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.
• Investigators: Principal Investigator: Filip Janku, MD, University of Texas MD Anderson Center; Principal Investigator: Gerald Falchook, MD, Sarah Cannon Research Institute-Denver

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): November 5, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (Estimated): January 22, 2016

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemic and Lymphatic Diseases; Lymphoma
• Other Study ID Numbers: FF1050201US101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No