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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

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