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NCT06582017 · ClinicalTrials.gov registry record · Phase 1
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
A Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by Nammi Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 8
- Study locations
NCT06582017 is a Phase 1 study of Breast Cancer and Prostate Cancer that is actively recruiting participants, run by Nammi Therapeutics. The registered enrollment target is 100 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 5 states.
The verdict
NCT06582017, a Phase 1 study of Breast Cancer and Prostate Cancer, is actively recruiting participants, sponsored by Nammi Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 8
- Study locations
Study Summary
Study QXL138AM-001 is a Phase 1a/1b study to investigate the safety, pharmacokinetics, and preliminary activity of QXL138AM in subjects with locally advanced un-resectable and/or metastatic solid tumors and multiple myeloma. The study is an open-label, multicenter, first in human study to be conducted in two major parts which are further organized into two sub-parts. Part A Dose Escalation is a modified 3+3 with the first two cohorts consisting of one subject each based on the low clinical starting dose. Dose escalation in solid tumors (Part A1) will be followed by dose finding in multiple myeloma (Part A2). Part B consists of dose expansion in solid tumors (Part B1) and multiple myeloma (Part B2) using the recommended dose for expansion from Part A
Conditions Studied
Interventions
- BIOLOGICAL QXL138AM Injection every 2 weeks by IV Infusion
Study Locations (8)
California
- University of Southern California - Los Angeles
- Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport
New York
- New York Cancer & Blood Specialists - New York
- University of Rochester - Wilmot Cancer Institute - Rochester
Colorado
- Sarah Cannon Research Institute - Denver DDU - Denver
Georgia
- Emory University - Winship Cancer Institute - Atlanta
Texas
- START San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-08-28 |
| Est. Completion | 2028-05-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06582017
The ClinicalTrials.gov registry entry for NCT06582017 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Nammi Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which QXL138AM Injection every 2 weeks by IV Infusion is the first listed.
NCT06582017 reports 8 study locations spanning 5 distinct geographic areas - top geographies include California, New York, Colorado.
Frequently Asked Questions
What is clinical trial NCT06582017 about?
NCT06582017 is a clinical study titled "Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma". Study QXL138AM-001 is a Phase 1a/1b study to investigate the safety, pharmacokinetics, and preliminary activity of QXL138AM in subjects with locally advanced un-resectable and/or metastatic solid tumors and multiple myeloma. The study is an open-label, multicenter, first in human study to be conduct...
What is the current status of trial NCT06582017?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-08-28. Estimated completion is 2028-05-30.
What conditions does trial NCT06582017 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Lung Cancer, Ovarian Cancer, Hepatocellular Carcinoma.
What interventions are being tested in trial NCT06582017?
The interventions under investigation include: QXL138AM Injection every 2 weeks by IV Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT06582017?
This trial is sponsored by Nammi Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06582017 being conducted?
This trial has 8 study locations across California, Colorado, Georgia, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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