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NM32-2668 in Adult Patients With Selected Advanced Solid Tumors

N

Numab Therapeutics

Status and phase

Enrolling
Phase 1

Conditions

Melanoma, Malignant
Ovarian Carcinoma
Adenocarcinoma - Gastroesophageal Junction (GEJ)
Mesothelioma, Malignant
Fallopian Tube Carcinoma
Peritoneal Carcinoma
Liposarcoma
Endometrial Cancer
Adenocarcinoma of the Stomach
Leiomyosarcoma
Renal Cell Carcinoma
Triple Negative Breast Cancer
Adenocarcinoma of Lung

Treatments

Biological: NM32-2668

Study type

Interventional

Funder types

Industry

Identifiers

NCT06299163
NB-NM032-2668-101

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

180 participants in 1 patient group

NM32-2668
Experimental group
Treatment:
Biological: NM32-2668

Trial contacts and locations

5

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Central trial contact

Martin Stern, MD

Data sourced from clinicaltrials.gov

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