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Recruiting
NCT07612189
A Study of NEOK002, an EGFR and MUC1 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: Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona DDU Orlando Florida
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 metatstatic 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.
* Participant 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.
Source: ClinicalTrials.gov (NCT07612189). StuddyBuddy aggregates publicly available trial information.