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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Nammi Therapeutics Inc
Study ID
NCT06582017
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QXL138AM Injection every 2 weeks by IV Infusion — BIOLOGICAL
    masked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a

Study Details

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

Key Dates

Start date
Aug 28, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
May 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a Dose Escalation in Solid Tumors - Part A1
    Dose escalation of QXL138AM in participants with locally advanced un-resectable and/or metastatic solid tumors.
  • Experimental: Phase 1a Dose Escalation in Multiple Myeloma - Part A2
    Dose escalation of QXL138AM in participants with multiple myeloma.
  • Experimental: Phase 1b Dose Expansion in Solid Tumors - Part B1
    Dose expansion in solid tumors using the recommended dose for expansion from Part A1
  • Experimental: Phase 1b Dose Expansion in Multiple Myeloma - Part B2
    Dose expansion in Multiple Myeloma using the recommended dose for expansion from Part A2

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Throughout study - anticipated 3.5 years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Cedars-Sanai Medical CenterLos AngelesCalifornia90048
Alain Mita, MD
Cedars-Sanai Medical Center - Samuel Oschin Comprehensive CancerLos AngelesCalifornia90048
Kamya Sankar, MD
[email protected]
248-802-2041
University of Southern CaliforniaLos AngelesCalifornia90033
Anthony El-Khoueiry, MD
[email protected]
323-865-3962
Hoag Memorial Hospital PresbyterianNewportCalifornia92663
Benjamin Goldenson, MD
[email protected]
949-764-4060
Sarah Cannon Research Institute - Denver DDUDenverColorado80218
Jason T Henry, MD
[email protected]
720-754-2610
Emory University - Winship Cancer InstituteAtlantaGeorgia30322
Fatemeh Ardeshir, MD
[email protected]
404-778-0202
New York Cancer & Blood SpecialistsNew YorkNew York11967
Richard Zuniga, MD
[email protected]
613-675-5075
University of Rochester - Wilmot Cancer InstituteRochesterNew York14642
Brea Lipe, MD
[email protected]
585-276-6302
START San AntonioSan AntonioTexas78229
Drew Drasco, MD
[email protected]
210-593-5258
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Binod Dhakal, MD

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