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

NCT02661542 | Completed Phase 1 Results FDA Drug

• 1 other identifier: FF1050201US101
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Solid Tumors; Lymphomas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of Subjects With Overall Response Rates (ORR)

  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

  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)

  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

  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)

  Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months

Study Arms (5)

Phase 1, Cohorts 1-9

EXPERIMENTAL

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

Phase 2a, Cohort 10, Advanced solid tumors

EXPERIMENTAL

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

Phase 2a, Cohort 11, Cholangiocarcinoma

EXPERIMENTAL

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

Phase 2a, Cohort 12, Gall bladder carcinoma

EXPERIMENTAL

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

Phase 2a, Cohort 13, Urothelial carcinoma

EXPERIMENTAL

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

Interventions

FF-10502-01 DRUG

Phase 1, Cohorts 1-9; Phase 2a, Cohort 10, Advanced solid tumors; Phase 2a, Cohort 11, Cholangiocarcinoma; Phase 2a, Cohort 12, Gall bladder carcinoma; Phase 2a, Cohort 13, Urothelial carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujifilm Pharmaceuticals U.S.A., Inc.: lead

Study Sites (2)

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, 80218, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Vice President of Clinical Operations and Development
• Organization: FUJIFILM Pharmaceuticals U.S.A, Inc.

fphucontact@fujifilm.com

(617) 945-3763

Study Officials

• Filip Janku, MD

  University of Texas MD Anderson Center

  PRINCIPAL INVESTIGATOR

• Gerald Falchook, MD

  Sarah Cannon Research Institute-Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 22, 2016
• Study Start: January 1, 2016
• Primary Completion: November 5, 2020
• Study Completion: November 5, 2020
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)