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

NCT06582017 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-13

No results posted yet for this 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

Interventions

BIOLOGICAL

QXL138AM Injection every 2 weeks by IV Infusion

masked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a

Sponsors & Collaborators

  • Nammi Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Dennis Kim, MD · Nammi Therapeutics Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-28
Primary Completion
2027-12-31
Completion
2028-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06582017 on ClinicalTrials.gov