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

RecruitingPhase 1Ages 18 Years - anyAllNEOK Bio, Inc.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ฅ 470 msec.
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What it tests

  • NEOK001
  • NEOK001 RDE
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Where

9 sites
Memorial Sloan Kettering Cancer Center
New York, United States
SCRI Oncology Partners
Nashville, United States
NEXT Oncology
Austin, United States
NEXT Oncology
Dallas, United States
SCRI at Mary Crowley
Dallas, United States
MD Anderson Cancer Center
Houston, United States
NEXT Oncology
Houston, United States
NEXT Oncology
San Antonio, United States

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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