Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors

NCT ID: NCT06086522

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-12-31

Brief Summary

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Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer).

Main questions:

* What does the study drug do to human body (Pharmacodynamics \[='PD'\])
* What does the body do to study drug (how processed in body (Pharmacokinetics \[='PK'\]) - Safety

Study drug by intravenous infusion ('IV') once weekly for 3 weeks every 4-week 'cycle.' Study treatment continues as long as patient and their study doctor agree that study treatment is in the best interest of the patient.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Dose escalation, Dose expansion
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Starting dose in Phase 1a dose escalation

Group Type OTHER

QN-302

Intervention Type DRUG

Phase 1 dose-finding study, the study design is for QN-302 to be given once a week, intravenously over 60 min, on Day 1, Day 8, and Day 15 of a 28-Day cycle.

Cohort 2

2nd cohort in Phase 1a dose escalation

Group Type OTHER

QN-302

Intervention Type DRUG

Phase 1 dose-finding study, the study design is for QN-302 to be given once a week, intravenously over 60 min, on Day 1, Day 8, and Day 15 of a 28-Day cycle.

Interventions

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QN-302

Phase 1 dose-finding study, the study design is for QN-302 to be given once a week, intravenously over 60 min, on Day 1, Day 8, and Day 15 of a 28-Day cycle.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically confirmed locally advanced or metastatic solid carcinomas, who have had tumor progression after receiving all standard of care therapies or for which there is no approved therapy 2. Evaluable or measurable disease by RECIST 1.1

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Translational Drug Development

OTHER

Sponsor Role collaborator

Qualigen Theraputics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tariq Arshad, MD

Role: STUDY_DIRECTOR

Qualigen Theraputics, Inc.

Locations

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HonorHealth

Scottsdale, Arizona, United States

Site Status RECRUITING

Yale

New Haven, Connecticut, United States

Site Status NOT_YET_RECRUITING

START Midwest

Grand Rapids, Michigan, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Tariq Arshad, MD

Role: CONTACT

use email

Facility Contacts

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Andrew Islas

Role: primary

833-354-6667

Role: backup

Abigail VanKirk

Role: primary

616-389-1824

Abigail VanKirk

Role: backup

616.389.1824

Other Identifiers

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302P1V01

Identifier Type: -

Identifier Source: org_study_id

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