RECRUITING

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

Conditions

Ovarian Cancer Pancreas Cancer Urothelial Carcinoma Renal Cell Carcinoma Hepatocellular Carcinoma Gastrointestinal Cancer Lung Cancer Prostate Cancer Breast Cancer QXL138AM-001 CD138 Interferon A Nammi Therapeutics Inc.

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A First-in-human Phase 1a/1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable and/or Metastatic Solid Tumors and Multiple Myeloma

Quick Facts

Study Start:2024-08-28

Study Completion:2028-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06582017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. 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.

Inclusion Criteria

Exclusion 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.

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.
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.

Contacts and Locations

Study Contact

David Stover, PhD

CONTACT

818-926-3428

David.Stover@nammirx.com

Principal Investigator

Dennis Kim, MD

STUDY_DIRECTOR

Nammi Therapeutics Inc

Study Locations (Sites)

University of Southern California

Los Angeles, California, 90033

United States

Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer

Los Angeles, California, 90048

United States

Hoag Memorial Hospital Presbyterian

Newport, California, 92663

United States

Sarah Cannon Research Institute - Denver DDU

Denver, Colorado, 80218

United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322

United States

New York Cancer & Blood Specialists

New York, New York, 11967

United States

University of Rochester - Wilmot Cancer Institute

Rochester, New York, 14642

United States

START San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Nammi Therapeutics Inc

Dennis Kim, MD, STUDY_DIRECTOR, Nammi Therapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28

Study Completion Date2028-05-30

Study Record Updates

Study Start Date2024-08-28

Study Completion Date2028-05-30

Terms related to this study

Keywords Provided by Researchers

QXL138AM-001
CD138
Interferon A
Nammi Therapeutics Inc.

Additional Relevant MeSH Terms

Ovarian Cancer
Pancreas Cancer
Urothelial Carcinoma
Renal Cell Carcinoma
Hepatocellular Carcinoma
Gastrointestinal Cancer
Lung Cancer
Prostate Cancer
Breast Cancer