Recruiting
Phase 1

Observational Study

Sponsor:

NEOK Bio, Inc.

Code:

NCT07612176

Conditions

Locally Advanced (Unresectable) or Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NEOK001

NEOK001 RDE

Study Details

Brief 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).

Conditions

Locally Advanced (Unresectable) or Metastatic Solid Tumors

Study ID

NCT07612176

Start date

Apr 21, 2026

Status verified date

Aug, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

155 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

experimental: Expansion

Interventions

NEOK001

Escalating doses of NEOK001

NEOK001 RDE

Recommended Dose of NEOK001 for Expansion

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Willie J Hudson, MS

615-507-4263whudson@neokbio.com

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Jamie Walters

917-843-7966waltersj@mskcc.org

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Tracey Zimmer

972-566-3000Tracey.Zimmer@scri.com

NEXT Oncology

Recruiting

Austin, Texas, United States, 78758

Contacts

Heather Watson

737-610-5202hwatson@nextoncology.com

NEXT Oncology

Recruiting

Dallas, Texas, United States, 75039

Contacts

Mofopefoluwa "Fope" Akinwale

972-893-8800fakinwale@nextoncology.com

SCRI at Mary Crowley

Recruiting

Dallas, Texas, United States, 75230

Contacts

Tracey Zimmer

972-566-3000Tracey.Zimmer@scri.com

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Romeena Momin

713-563-1055RBMomin@mdanderson.org

NEXT Oncology

Recruiting

Houston, Texas, United States, 77054

Contacts

Emma Morales

832-384-7912emorales@nextoncology.com

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78299

Contacts

Jordan Georg

210-580-9521Jgeorg@nextoncology.com

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

703-783-4518Mdelarosa@nextoncology.com

More Information

Sponsor

NEOK Bio, Inc.

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Antibody-Drug Conjugate
  • ADC
  • Bispecific
  • B7-H3
  • ROR1
  • Locally Advanced
  • Unresectable
  • Metastatic
  • Solid Tumor
  • oncology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NEOK Bio, Inc. on 2026-09-02.