A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNEOK Bio, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- NEOK001
- NEOK001 RDE
Treatment groups
155 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov