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Trial Title:
NM32-2668 in Adult Patients With Selected Advanced Solid Tumors
NCT ID:
NCT06299163
Condition:
Ovarian Carcinoma
Fallopian Tube Carcinoma
Peritoneal Carcinoma
Endometrial Cancer
Adenocarcinoma of Lung
Triple Negative Breast Cancer
Liposarcoma
Leiomyosarcoma
Mesothelioma, Malignant
Adenocarcinoma - Gastroesophageal Junction (GEJ)
Adenocarcinoma of the Stomach
Melanoma, Malignant
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Melanoma
Adenocarcinoma
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Mesothelioma
Mesothelioma, Malignant
Leiomyosarcoma
Liposarcoma
Adenocarcinoma of Lung
Melanoma, Cutaneous Malignant
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
NM32-2668
Description:
Anti-ROR1/Anti-Cluster of Differentiation 3 (CD3)/Anti-Human Serum Albumin (HSA)
Tri-Specific Antibody
Arm group label:
NM32-2668
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jacob thomas
Investigator:
Last name:
Jacob thomas
Email:
Principal Investigator
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Faith Gilchrist
Investigator:
Last name:
Niharika Mettu, MD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Regina Yu
Investigator:
Last name:
Dale Shepard
Email:
Principal Investigator
Facility:
Name:
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Jandecka
Investigator:
Last name:
Jason Luke
Email:
Principal Investigator
Facility:
Name:
Lifespan Cancer Institute at Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benedito A. Carneiro, MD
Investigator:
Last name:
Benedito A. Carneiro, MD
Email:
Principal Investigator
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas W. Orr, MD
Investigator:
Last name:
Douglas W. Orr, MD
Email:
Principal Investigator
Start date:
May 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Numab Therapeutics AG
Agency class:
Industry
Source:
Numab Therapeutics AG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06299163