Patient dosing has begun in a phase 1 trial evaluating QXL138AM, a masked immunocytokine targeting CD138, in advanced solid tumors and multiple myeloma.
Trial Name: A First-in-human Phase 1a/1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Unresectable and/or Metastatic Solid Tumors and Multiple Myeloma
ClinicalTrials.gov Identifier: NCT06582017
Sponsor: Nammi Therapeutics Inc
Recruitment Contact: David Stover, PhD, 818-926-3428, David.Stover@nammirx.com
Completion Date: May 30, 2028
The first patient has been dosed with QXL138AM in a first-in-human, phase 1 trial (NCT06582017) for the treatment of locally advanced unresectable and/or metastatic solid tumors and multiple myeloma.1
QXL138AM is a masked immunocytokine composed of a masked interferon alpha fused to an antibody that targets the CD138 protein on the surface of the tumor cells. Previously, the agent was granted orphan drug designation from the FDA in pancreatic cancer.
This 2-part, open-label, multicenter, phase 1 trial is now evaluating the safety, pharmacokinetics (PK), and preliminary activity of QXL138AM in approximately 100 patients with advanced CD138-expressing cancers.2
"Interferon alpha 2 is a potent anticancer therapeutic, but its clinical benefit is limited by significant toxicity when administered systematically. QXL138AM utilizes Nammi's masked immunocytokine technology, whereby the interferon alpha 2 is masked and fused to a tumor-targeting antibody. The antibody anchors QXL138AM on the surface of tumor cells where proteases can remove the mask thereby activating the Interferon alpha 2, facilitating a wider therapeutic window," said Dennis Kim, MD, chief medical officer for the study, in a press release.1
In part A of the trial, experts will evaluate the safety and tolerability of QXL138AM given at escalating doses.2 The secondary end points include PK and immunogenicity. For part B, dose-expansion in 3 cohorts, 2 of which are solid tumor indications with high CD138 prevalence and 1 for multiple myeloma. The primary end points being evaluated in this portion of the study include safety and tolerability, and secondary end points will evaluate antitumor activity.
For those enrolled with solid tumors, patients are required to have a histopathologically confirmed diagnosis of an advanced, unresectable, or metastatic ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal, lung, prostate, or breast cancer. Eligible patients should have experienced disease progression despite standard therapies or have tumors for which conventional treatments are ineffective or intolerable, as assessed by the investigator. Patients must lack alternative therapeutic options that are known to provide clinical benefit for their specific tumor type.
Patients with multiple myeloma must have experienced disease progression despite standard therapies or have tumors for which conventional treatments are ineffective or intolerable, as determined by the investigator. Moreover, all patients must have failed at least 3 prior myeloma treatments and should have previously been treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38–directed therapy.
Enrollment is also open to patients aged 18 years and older who have an ECOG performance status scale of 0, 1, or 2 at screening 4, at least 1 measurable lesion by RECIST version 1.1, adequate organ function and bone marrow reserve, and adequate cardiac function.
The study is being conducted at investigator sites across the US. The estimated study completion date is May 30, 2028.
"We're very excited to have dosed the first patient with QXL138AM here at START," stated Drew W. Rasco, MD, associate director at The START Center for Cancer Research in San Antonio, TX, in a press release.1 "We believe that there is significant potential with Nammi's immunocytokine technology in the treatment of multiple cancer types, and we look forward to working with the Nammi team to develop this new therapy over the coming years.”
