Locally Advanced (Unresectable) or Metastatic Solid TumorsPhase 1NCT07612189
A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors
A Phase 1 study testing NEOK002 and NEOK002 RDE in people with Locally Advanced (Unresectable) or Metastatic Solid Tumors, run by NEOK Bio, Inc. at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced (Unresectable) or Metastatic Solid Tumors
- What is being tested?
- NEOK002 and NEOK002 RDE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 10 sitesUnited States
- Study dates
- 22 Apr 2026to Feb 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
NEXT Oncology
Austin, Texas, 78758
Heather Watson, 737-610-5202, hwatson@nextoncology.com
- Recruiting
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75230
Douglas Orr, MD, 972-566-3000, MaryCrowleyReferral@scri.com
- Recruiting
NEXT Oncology
Dallas, Texas, 78299
Mofopefoluwa "Fope" Akinwale, 972-893-8800, fakinwale@nextoncology.com
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
Maybelle De La Rosa, 703-783-4518, Mdelarosa@nextoncology.com
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
713-563-1055
- Recruiting
NEXT Oncology
Houston, Texas, 77054
Emma Morales, 832-384-7912, emorales@nextoncology.com
- Recruiting
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, 37203
Tracey Zimmer, 972-566-3000, Tracey.Zimmer@scri.com
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
646-888-4167
- Recruiting
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona DDU
Orlando, Florida, 32827
904-380-2410
- Recruiting
NEXT Oncology
San Antonio, Texas, 75039
Jordan Georg, 210-580-9521, Jgeorg@nextoncology.com
About this study
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
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).
Read the 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.
- Being tested
- NEOK002, NEOK002 RDE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEOK002Drug
Escalating doses of NEOK002
NEOK002 RDEDrug
Recommended NEOK002 dose(s) for Expansion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | NEOK002 Receives: Drug: NEOK002 |
| Dose Expansion | Experimental | Recommended Dose of NEOK002 for Expansion Receives: Drug: NEOK002 RDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)
Incidence and severity of DLTs during the first cycle of treatment in Part A
Measured: 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
Measured: 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)
Measured: 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.
Measured: Through study completion, estimated as 32 months
Secondary outcomes (3)
Part B: Incidence of AEs
Incidence of TEAEs and SAEs in participants in Part B
Measured: Through study completion, estimated as 32 months
Maximum Concentration (Cmax) of NEOK002
Assessment of plasma pharmacokinetics (PK) parameters of NEOK002: Cmax
Measured: 21 days
Terminal Elimination Half Life (T1/2) of NEOK002
Assessment of plasma PK parameters of NEOK002: T1/2
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start22 Apr 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced (Unresectable) or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose Escalation followed by Dose Expansion
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEOK Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612189
- Sponsor's protocol ID
- NEOK002-1
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No