MedTrace Logo

Evaluate the Safety of BEL-X-HG in Advanced Cancer Patients

NCT03256331 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-06-01

No results posted yet for this study

Summary

This is a Phase I, open-label, uncontrolled, multicenter dose escalation and extension study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate safety / tolerability and preliminary effects of BEL-X-HG in patients with advanced refractory solid tumors. Dose escalation during the study will be made based on dose-limiting toxicity (DLT).

Conditions

Interventions

DRUG

BEL-X-HG

This study will be carried out in 2 parts: 1. A sequential Dose Escalation Part of four doses following a 3 + 3 design where dose escalation will be made based on DLT, for a single cycle (28 days) of BEL-X-HG treatment 2. A Dose Extension Part of up to 5 cycles (28 days each) at the same dose level (starting dose) of BEL-X-HG treatment Escalating dose levels of BEL-X-HG in 5 study cohorts and one modified dose will be as follows: * Cohort 1: Dose level 1 - 0.5 g/day (0.25 g, bid) * Cohort 2: Dose level 2 - 1.0 g/day (0.5 g, bid) * Cohort 3: Dose level 3 - 2.0 g/day (1.0 g, bid) * Cohort 4: Dose level 4 - 4.0 g/day (2.0 g, bid) Modified dose level Cohort 5: Dose level 5 - 1.5 g/day (0.75g bid) This re-escalation is allowed only when dose de-escalates from Dose level 3 to Dose level 2, and 1 DLT in 6 evaluable subjects of Dose level 2.

Sponsors & Collaborators

  • A2 Healthcare Taiwan Corporation

    collaborator INDUSTRY

  • Belx Bio-Pharmaceutical (Taiwan) Corporation

    lead INDUSTRY

Principal Investigators

  • Chia-Chi Lin, MD, PhD · National Taiwan University Hospital

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2020-03-30
Completion
2020-03-30
FDA Drug
Yes

Countries

  • Taiwan

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 NCT03256331 on ClinicalTrials.gov