A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NEOK002, NEOK002 RDE.
- Who it may be relevant to
- Registry conditions: Locally Advanced (Unresectable) or Metastatic Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific Antibody-Drug, Conjugate in Participants With Select Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
Overview
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).
Detailed description
This is a FIH, Phase 1, open-label, multicenter, multiple-dose, dose escalation and expansion study. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B). NEOK001 is a bispecific EGFR and MUC1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.
Interventions
- Drug NEOK002
Escalating doses of NEOK002 - Drug NEOK002 RDE
Recommended NEOK002 dose(s) for Expansion
Primary outcome measures
- Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs) [Time frame: 21 days]
- Part A: Incidence and Severity of Adverse Events (AEs) [Time frame: Through study completion, estimated as 32 months]
- Part B: Investigator Assessment of Objective Response Rate (ORR) [Time frame: Through study completion, estimated as 32 months]
- Part B: Duration of Response (DOR) [Time frame: Through study completion, estimated as 32 months]
Secondary outcome measures (3)
- Part B: Incidence of AEs [Time frame: Through study completion, estimated as 32 months]
- Maximum Concentration (Cmax) of NEOK002 [Time frame: 21 days]
- Terminal Elimination Half Life (T1/2) of NEOK002 [Time frame: 21 days]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- Memorial Sloan Kettering Cancer Center — New York
- SCRI Oncology Partners — Nashville
- NEXT Oncology — Austin
- NEXT Oncology — Dallas
- MD Anderson Cancer Center — Houston
- NEXT Oncology — Houston
- NEXT Oncology — San Antonio
- NEXT Oncology — Fairfax
Identifiers
NCT: NCT07612189 · NEOK002-1