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RECRUITING Phase 1

Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma

NCT06582017 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 100 participants
Start Date 2024-08-28
Est. Completion 2028-05-30
Phase Phase 1

Sponsor

Nammi Therapeutics

28 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nammi Therapeutics, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06582017 reports 8 study locations spanning 5 distinct geographic areas — top geographies include California, New York, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06582017?

The interventions under investigation include: QXL138AM Injection every 2 weeks by IV Infusion (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06582017?

This trial is sponsored by Nammi Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial