Recruiting
Phase 1

QXL138AM

Sponsor:

Nammi Therapeutics Inc

Code:

NCT06582017

Conditions

Ovarian Cancer

Pancreas Cancer

Urothelial Carcinoma

Renal Cell Carcinoma

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

QXL138AM Injection every 2 weeks by IV Infusion

Study Details

Brief 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

Ovarian Cancer

Pancreas Cancer

Urothelial Carcinoma

Renal Cell Carcinoma

Hepatocellular Carcinoma

Study ID

NCT06582017

Start date

Aug 28, 2024

Status verified date

Apr, 2026

Completion date

May 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants with Solid Tumors

  • Histopathologically confirmed diagnosis of an advanced, unresectable, or metastatic solid tumor (ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal (GI), lung, prostate, and breast cancer).
  • Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator. Patients must have no available therapeutic options known to confer clinical benefit for their tumor type.
2. Participants with Multiple Myeloma

  • Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator.
  • Patients must have failed at least 3 prior therapies for myeloma and should have had prior exposure to a proteosome inhibitor, an IMiD, and an anti-CD38-directed therapy.

2\. Male or female participants ≥18 years of age at the time of informed consent 3. An Eastern Cooperative Oncology Group (ECOG) performance status scale of 0, 1, or 2 at Screening 4. Must have at least 1 measurable lesion by RECIST version 1.1 (solid tumors only), or evaluable disease by IMWG Uniform Response Criteria (multiple myeloma only) 5. Adequate organ function and bone marrow reserve 6. Adequate cardiac function as estimated by left ventricular ejection fraction 7. Female participants of child-bearing potential must:

  • Have a negative serum pregnancy test at screening and a negative pregnancy test at Week 1 Day 1 prior to first dose of QXL138AM, AND
  • Agree to use at least 1 highly effective method of contraception for the duration of study participation, and for 120 days after last dose of QXL138AM.

8\. Male participants of child-bearing potential must:
  • Agree to use at least 1 highly effective method of contraception for the duration of study participation, and for 120 days after last dose of QXL138AM, AND
  • Refrain from sperm donation prior to the first dose of investigational product through 120 days following the last dose of QXL138AM.

Exclusion Criteria:

1. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, a history of risk factors for Torsades de Pointes (TdP), including heart failure, hypokalemia, and family history of long QTc syndrome, or evidence of ischemia on ECG.

Symptomatic ischemic heart disease or unstable angina pectoris; or history of cardiac angioplasty, cardiac stenting, or coronary artery bypass graft. A clinically significant baseline prolongation of QT/QTcF interval at screening.
2. The use of concomitant medications that may significantly prolong the QT/QTc interval.
3. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
4. Known hypersensitivity to the investigational product or components (anti-CD138 IgG1 antibody, Interferon A2a and/or the formulation excipients: histidine, sucrose, arginine, polysorbate 80).
5. Female participant is lactating.
6. Any other clinically significant comorbidities.
7. Received prior anticancer therapy within 28 days or 5x the half-life (whichever is shorter) prior to the first dose of investigational product.
8. Participants who received wide-field radiation therapy within 4 weeks prior to first dose of investigational product, (2 weeks for limited field radiation therapy)
9. Major surgery within 30 days before first dose of investigational product
10. Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent.
11. Active, clinically significant liver disease such as Hepatitis B or C, autoimmune hepatitis, or cirrhosis (Child Hugh Stage B or C).
12. Current or history of mood disorder such as major depression per DSM-5 within past two years not controlled with current therapy.
13. Active autoimmune disorders not controlled with current therapy.
14. Active endocrine disorders including hypothyroidism, hyperthyroidism, hypoglycemia, hyperglycemia, and diabetes mellitus not controlled with current therapy.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

QXL138AM Injection every 2 weeks by IV Infusion

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Anthony El-Khoueiry, MD

323-865-3962elkhouei@med.usc.edu

Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer

Recruiting

Los Angeles, California, United States, 90048

Contacts

Cedars-Sanai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Hoag Memorial Hospital Presbyterian

Recruiting

Newport, California, United States, 92663

Contacts

Sarah Cannon Research Institute - Denver DDU

Recruiting

Denver, Colorado, United States, 80218

Contacts

Emory University - Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

New York Cancer & Blood Specialists

Recruiting

New York, New York, United States, 11967

Contacts

University of Rochester - Wilmot Cancer Institute

Recruiting

Rochester, New York, United States, 14642

Contacts

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Froedtert Hospital & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Nammi Therapeutics Inc

Last update posted

Aug 27, 2026

Last verified

Apr, 2026

Keywords

  • QXL138AM-001
  • CD138
  • Interferon A
  • Nammi Therapeutics Inc.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nammi Therapeutics Inc on 2026-08-27.