Suspended

A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Immune System Diseases+5

+ Immunoproliferative Disorders

+ Lymphatic Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2004
See protocol details

Summary

Principal SponsorNovacea
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2004

Actual date on which the first participant was enrolled.

This study is for people who have advanced cancer for which standard chemotherapy did not work or for which there are no reliably, effective treatments. AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply; tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment. AQ4N may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide, causing tumors to die or to delay their growth. All patients in this study will receive AQ4N. The dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached.

Official TitleA Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies 
Principal SponsorNovacea
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type

Criteria

Inclusion Criteria: * Advanced solid malignancy or non-Hodgkin's lymphoma that is refractory to treatment or has recurred * Age \> 18 years * Adequate hematologic (blood), kidney and liver function * Negative pregnancy test (females of childbearing potential only) * Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment. Exclusion Criteria: * Any chemotherapy or radiation within the past 4 weeks * Symptomatic or uncontrolled brain metastases (patients with history of brain metastases who have had repeat brain scans within the past 30 days that demonstrate no evidence of tumor progression or brain swelling and who do not require corticosteriod treatment may be eligible) * Significant cardiovascular illness including, but not limited to, the following: active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, heart attack within the past six months, or uncontrolled, irregular heart beat * Inadequate cardiac function * Prior investigational therapy within the past 28 days * Pregnant or breast feeding women

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Weiler Hospital of Albert Einstein College of Medicine

Bronx, United StatesSee the location
Suspended

Cancer Therapy & Research Center / Institute for Drug Development

San Antonio, United States
Suspended2 Study Centers