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

  • Recruiting
  • Treatment
  • Interventional
  • Non Randomized
  • Biological
  • PHASE1
  • Nammi Therapeutics Inc
  • 18 Years -


Study Purpose

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

Intervention

Biological : QXL138AM Injection every 2 weeks by IV Infusion


Eligibility Requirements

info icon 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.

info icon 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.

info icon 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:

info icon 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

info icon 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:

info icon 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

info icon Refrain from sperm donation prior to the first dose of investigational product through 120 days following the last dose of QXL138AM.

info icon 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.

info icon 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.

info icon The use of concomitant medications that may significantly prolong the QT/QTc interval.

info icon Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.

info icon Known hypersensitivity to the investigational product or components (anti-CD138 IgG1 antibody, Interferon A2a and/or the formulation excipients: histidine, sucrose, arginine, polysorbate 80).

info icon Female participant is lactating.

info icon Any other clinically significant comorbidities.

info icon Received prior anticancer therapy within 28 days or 5x the half-life (whichever is shorter) prior to the first dose of investigational product.

info icon Participants who received wide-field radiation therapy within 4 weeks prior to first dose of investigational product, (2 weeks for limited field radiation therapy)

info icon Major surgery within 30 days before first dose of investigational product

info icon Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent.

info icon Active, clinically significant liver disease such as Hepatitis B or C, autoimmune hepatitis, or cirrhosis (Child Hugh Stage B or C).

info icon Current or history of mood disorder such as major depression per DSM-5 within past two years not controlled with current therapy.

info icon Active autoimmune disorders not controlled with current therapy.

info icon Active endocrine disorders including hypothyroidism, hyperthyroidism, hypoglycemia, hyperglycemia, and diabetes mellitus not controlled with current therapy.

Recruiting status

Recruiting

Estimated enrollment

100

 
Study start date

Aug 28, 2024

Study end date

May 30, 2028

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Biological

Study phase

PHASE1

Allocation

Non Randomized

 

Sponsor:

Nammi Therapeutics Inc

Collaborator:

N/A

Investigator:

Dennis Kim, MD

NCT06582017

Clinic Location Investigator Distance RECRUITING STATUS Contact