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NM32-2668 in Adult Patients With Selected Advanced Solid Tumors
A Phase 1 Study of NM32-2668 (Anti-ROR1/CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients With Selected Advanced Solid Tumors
1 other identifier
interventional
11
1 country
11
Brief Summary
This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2024
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2025
CompletedJuly 23, 2025
July 1, 2025
12 months
February 26, 2024
July 18, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Incidence of Dose Limiting Toxicities (DLTs)
Through 28 days post-infusion
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 / ASTCT (for Cytokine Release Syndrome [CRS])
Through 50 days post-final dose administration
Frequency of dose interruptions/reductions
Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first
Duration of dose interruptions/reductions
Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first
Secondary Outcomes (22)
Assessment of the maximum observed serum concentration (Cmax)
From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the the minimum observed serum concentration (Cmin)
From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Time from dosing at which maximum observed serum concentration is apparent (Tmax)
From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the terminal phase (apparent elimination) rate constant (λz)
From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the elimination half-life (t½)
From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
- +17 more secondary outcomes
Study Arms (1)
NM32-2668
EXPERIMENTALInterventions
Anti-ROR1/Anti-Cluster of Differentiation 3 (CD3)/Anti-Human Serum Albumin (HSA) Tri-Specific Antibody
Eligibility Criteria
You may qualify if:
- Patients with histologically confirmed, advanced-stage protocol-specified solid tumors.
- Confirmed ROR1 tumor expression.
- Patients who have undergone at least one prior systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable or have medical contraindications to standard therapy.
You may not qualify if:
- Prior treatment with any agent targeting ROR1 or prior treatment with a CD3 T-cell engaging therapy.
- Prior treatment with chimeric antigen receptor (CAR) cell therapy within 90 days prior to first dose of NM32-2668.
- Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of NM32-2668.
- Wide-field radiotherapy (\> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of NM32-2668, or no recovery from side effects of such prior interventions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637, United States
Duke University
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2024
First Posted
March 7, 2024
Study Start
May 1, 2024
Primary Completion
April 18, 2025
Study Completion
April 18, 2025
Last Updated
July 23, 2025
Record last verified: 2025-07