MedTrace Logo

A Phase 1 Study to Evaluate FN-1501 Monotherapy in Patients With Advanced Solid Tumors and R/R AML

NCT03690154 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-10-13

No results posted yet for this study

Summary

This research study is being done in people with advanced-stage solid tumor cancer. Advanced stage solid tumor cancer is a cancer that forms an abnormal mass of tissue that usually does not contain cysts or liquid areas. Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors include lung cancer, breast cancer, prostate cancer, kidney cancer, colorectal cancer, melanoma and sarcoma.

The purpose of this research study is to evaluate the safety of the investigational study drug, FN-1501, at different dose levels. FN-1501 has not previously been given to human subjects. It is intended for the treatment in this study of patients with advanced solid tumor cancers. This study will determine the effects, good and/or bad, on patients' cancer. The main objective of this study is to define the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of FN-1501. The MTD is the highest dose a person can take without having bad side effects, and the RP2D will be the dose of FN-1501 used in future studies.

Conditions

Interventions

DRUG

FN-1501

Eligible patients will receive a single intravenous infusion of study drug on Days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Dosing will begin at 2.5 mg once per day on the assigned days. Dose escalation will use the traditional 3+3 design and follow a modified Fibonacci sequence until MTD is reached. Increments of 33% in the dose of FN-1501 will be undertaken after reaching 30 mg/day. At least 3 patients will be enrolled in each cohort. Administration of FN-1501 will be continued until disease progression, intolerable toxicity, withdrawal of consent, or termination according to the Principal Investigator's judgment or at the sponsor's request.

Sponsors & Collaborators

  • Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Ai-Min Hui, MD, PhD · Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2022-02-11
Completion
2022-02-11
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690154 on ClinicalTrials.gov