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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NEOK002 — DRUG
  Escalating doses of NEOK002
• NEOK002 RDE — DRUG
  Recommended NEOK002 dose(s) for Expansion

Study Details

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).

Key Dates

Start date

Apr 22, 2026

Status verified

May 2026

Primary completion

Feb 28, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

155 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation
  NEOK002
• Experimental: Dose Expansion
  Recommended Dose of NEOK002 for Expansion

Primary Outcome Measure

Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

• Beth Lepping, RN, BSN, MS
  610-207-2119
  [email protected]

Locations (8)

Find similar trials in New York, NY

Related Studies

• A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors
  PHASE1 · Recruiting · NEOK Bio, Inc. · New York, New York