NM32-2668 in Adult Patients With Selected Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06299163

Run by

Numab Therapeutics AG

People needed

11

Starts

2024-05-01

Expected to finish

2025-04-18

Last updated by the study team

2025-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• The University of Chicago Medical Center (UCMC) — Chicago, Illinois, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Lifespan Cancer Institute at Rhode Island Hospital — Providence, Rhode Island, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.