NM32-2668 in Adult Patients with Selected Advanced Solid Tumors

Last updated: November 12, 2024
Sponsor: Numab Therapeutics AG
Overall Status: Active - Recruiting

Phase

1

Condition

Endometrial Cancer

Adenocarcinoma

Carcinoma

Treatment

NM32-2668

Clinical Study ID

NCT06299163
NB-NM032-2668-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with histologically confirmed, advanced-stage protocol-specified solidtumors.

  • Confirmed ROR1 tumor expression.

  • Patients who have undergone at least one prior systemic therapy and haveradiologically or clinically determined progressive disease during or after mostrecent line of therapy, and for whom no further standard therapy is available, orwho are intolerable or have medical contraindications to standard therapy.

Exclusion

Exclusion Criteria:

  • Prior treatment with any agent targeting ROR1 or prior treatment with a CD3 T-cellengaging therapy.

  • Prior treatment with chimeric antigen receptor (CAR) cell therapy within 90 daysprior to first dose of NM32-2668.

  • Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever isshorter, prior to first dose of NM32-2668.

  • Wide-field radiotherapy (> 30% of marrow-bearing bones) within 28 days, or focalradiation for analgesic purpose or for lytic lesions at risk of fracture within 14days prior to first dose of NM32-2668, or no recovery from side effects of suchprior interventions.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: NM32-2668
Phase: 1
Study Start date:
May 01, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Lifespan Cancer Institute at Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

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