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Recruiting NCT07612176

A Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors

Conditions: Locally Advanced (Unresectable) or Metastatic Solid Tumors

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 155
Sponsor: NEOK Bio, Inc.

Location: Memorial Sloan Kettering Cancer Center New York New York

Summary

This is a first in human (FIH), Phase 1, dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).

Eligibility Criteria

Key Inclusion Criteria: * Participants must have locally advanced or metastatic disease in a select tumor type, for which no standard therapy is available. * Participants must have at least 1 measurable target lesion based on RECIST v1.1. * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participants must have adequate hematologic, hepatic, and renal function. * Participants should have available archived tumor tissue from their most recent biopsy. Key Exclusion Criteria: * Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component. * Participants with known symptomatic central nervous system (CNS) metastases or any evidence of leptomeningeal disease or evidence of unstable CNS metastases, even if asymptomatic. * Participants with a known history of interstitial lung disease (ILD) requiring steroid treatment, or for whom suspected ILD cannot be ruled out by imaging at screening. * Participants with clinically severe pulmonary compromise due to intercurrent pulmonary illness and/or pulmonary disorder requiring supplemental oxygen or any prior pneumonectomy. * Participants with a QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07612176). StuddyBuddy aggregates publicly available trial information.