Clinical trial · Interventional
A Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors
A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific Antibody-Drug Conjugate, in Participants With Select, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
NCT07612176CI-TRIAL-00125368recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced (Unresectable) or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NEOK001 | Drug | — | UNRESOLVED |
| NEOK001 RDE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- interventionNames
- Drug: NEOK001
- type
- EXPERIMENTAL
- label
- Expansion
- interventionNames
- Drug: NEOK001 RDE
Primary outcomes (4)
- measure
- Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)
- timeFrame
- 21 Days
- description
- Incidence and severity of DLTs during the first cycle of treatment in Part A
- measure
- Part A: Incidence and Severity of Adverse Events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKwon JA, Lee S, Kim J, Yoo BM, Park HJ, Ryu I, Kim J, Eom J, Son YG, Yeom D, Sung B, Yoo M, Seo A, Yoo J, Park JY, Jung J, Ahn J, You WK, Lee SH, Ko MJ. Preclinical development of ABL206, a novel bispecific antibody-drug conjugate targeting B7-H3 and ROR1. MAbs. 2026 Dec;18(1):2731283. doi: 10.1080/19420862.2026.2731283. Epub 2026 Sep 12. PMID 42731893