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

Qualigen Theraputics

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: QN-302

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06086522

302P1V01

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Cohort 1

Other group

Description:

Starting dose in Phase 1a dose escalation

Treatment:

Drug: QN-302

Cohort 2

Other group

Description:

2nd cohort in Phase 1a dose escalation

Treatment:

Drug: QN-302