NCT07612189

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for phase_1

Timeline
30mo left

Started Apr 2026

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Feb 2029

Study Start

First participant enrolled

April 22, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

May 21, 2026

Last Update Submit

May 28, 2026

Conditions

Locally Advanced (Unresectable) or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (4)

  • Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)

    Incidence and severity of DLTs during the first cycle of treatment in Part A

    21 days

  • Part A: Incidence and Severity of Adverse Events (AEs)

    Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients in Part A

    Through study completion, estimated as 32 months

  • Part B: Investigator Assessment of Objective Response Rate (ORR)

    Percentage of patients who achieve a confirmed objective response (ORR)

    Through study completion, estimated as 32 months

  • Part B: Duration of Response (DOR)

    The time from the first documentation of tumor response (complete or partial) until disease progression or death.

    Through study completion, estimated as 32 months

Secondary Outcomes (3)

  • Part B: Incidence of AEs

    Through study completion, estimated as 32 months

  • Maximum Concentration (Cmax) of NEOK002

    21 days

  • Terminal Elimination Half Life (T1/2) of NEOK002

    21 days

Study Arms (2)

Dose Escalation

EXPERIMENTAL

NEOK002

Drug: NEOK002

Dose Expansion

EXPERIMENTAL

Recommended Dose of NEOK002 for Expansion

Drug: NEOK002 RDE

Interventions

NEOK002DRUG

Escalating doses of NEOK002

Dose Escalation
NEOK002 RDEDRUG

Recommended NEOK002 dose(s) for Expansion

Dose Expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

NOT YET RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

NEXT Oncology

Austin, Texas, 78758, United States

NOT YET RECRUITING

NEXT Oncology

Dallas, Texas, 78299, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

NEXT Oncology

Houston, Texas, 77054, United States

NOT YET RECRUITING

NEXT Oncology

San Antonio, Texas, 75039, United States

RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

NOT YET RECRUITING

Central Study Contacts

Beth Lepping, RN, BSN, MS

CONTACT

610-207-2119blepping@neokbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Dose Escalation followed by Dose Expansion
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 28, 2026

Study Start

April 22, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(8)