Locally Advanced (Unresectable) or Metastatic Solid TumorsPhase 1NCT07612176
A Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors
A Phase 1 study testing NEOK001 and NEOK001 RDE in people with Locally Advanced (Unresectable) or Metastatic Solid Tumors, run by NEOK Bio, Inc. at 9 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?
- NEOK001 and NEOK001 RDE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Apr 2026to Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
NEXT Oncology
Austin, Texas, 78758
Heather Watson, 737-610-5202, hwatson@nextoncology.com
- Recruiting
NEXT Oncology
Dallas, Texas, 75039
Mofopefoluwa "Fope" Akinwale, 972-893-8800, fakinwale@nextoncology.com
- Recruiting
SCRI at Mary Crowley
Dallas, Texas, 75230
Douglas Orr, M.D., 972-566-3000, MaryCrowleyReferral@scri.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
Romeena Momin, 713-563-1055, RBMomin@mdanderson.org
- Recruiting
NEXT Oncology
Houston, Texas, 77054
Emma Morales, 832-384-7912, emorales@nextoncology.com
- Recruiting
SCRI 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
Jamie Walters, 917-843-7966, waltersj@mskcc.org
- Recruiting
NEXT Oncology
San Antonio, Texas, 78299
Jordan Georg, 210-580-9521, Jgeorg@nextoncology.com
About this study
Official title: A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 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 B7-H3 x ROR1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.
- Being tested
- NEOK001, NEOK001 RDE
- Keywords
- Antibody-Drug Conjugate, ADC, Bispecific, B7-H3, ROR1, Locally Advanced, Unresectable, Metastatic, Solid Tumor, oncology
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEOK001Drug
Escalating doses of NEOK001
NEOK001 RDEDrug
Recommended Dose of NEOK001 for Expansion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Not described Receives: Drug: NEOK001 |
| Expansion | Experimental | Not described Receives: Drug: NEOK001 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 participants in Part A
Measured: Through study completion, estimated as 32 months
Part B: Investigator Assessment of Objective Response Rate (ORR)
Percentage of participants 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)
Assessment of plasma pharmacokinetics (PK) of NEOK001 maximum observed concentration (Cmax) of NEOK001.
Measured: 21 days
Terminal Elimination Half Life (T1/2)
Assessment of plasma PK of NEOK001 terminal elimination half-life (T1/2).
Measured: 21days
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 start21 Apr 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 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
- NCT07612176
- Sponsor's protocol ID
- NEOK001-1
- Status last verified
- Aug 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
Publications
Kwon JA, Lee S, Kim J, Yoo BM, Park HJ, Ryu I, Kim J, Eom J, Son YG, Yeom D, Sung B, Yoo M, Seo A, Yoo J, Park JY, Jung J, Ahn J, You WK, Lee SH, Ko MJ. Preclinical development of ABL206, a novel bispecific antibody-drug conjugate targeting B7-H3 and ROR1. MAbs. 2026 Dec;18(1):2731283. doi: 10.1080/19420862.2026.2731283. Epub 2026 Sep 12.
PubMed 42731893
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific Antibody-Drug Conjugate, in Participants With Select, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07612176
- Acronym / sponsor ID
- NEOK001-1
- Keywords
- Antibody-Drug Conjugate, ADC, Bispecific, B7-H3, ROR1, Locally Advanced, Unresectable, Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- NEOK Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 B7-H3 x ROR1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose Escalation followed by Expansion
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: NEOK001 |
| Expansion | Experimental | Drug: NEOK001 RDE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEOK001Escalating doses of NEOK001 | Drug | Dose Escalation |
| NEOK001 RDERecommended Dose of NEOK001 for Expansion | Drug | Expansion |
Primary outcome
Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)
Time frame: 21 Days
Incidence and severity of DLTs during the first cycle of treatment in Part A
Part A: Incidence and Severity of Adverse Events (AEs)
Time frame: Through study completion, estimated as 32 months
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in participants in Part A
Part B: Investigator Assessment of Objective Response Rate (ORR)
Time frame: Through study completion, estimated as 32 months
Percentage of participants who achieve a confirmed objective response (ORR)
Part B: Duration of Response (DOR)
Time frame: Through study completion, estimated as 32 months
The time from the first documentation of tumor response (complete or partial) until disease progression or death.
3 secondary outcomes
Part B: Incidence of AEs
Time frame: Through study completion, estimated as 32 months
Maximum Concentration (Cmax)
Time frame: 21 days
Terminal Elimination Half Life (T1/2)
Time frame: 21days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 42731893Kwon JA, Lee S, Kim J, Yoo BM, Park HJ, Ryu I, Kim J, Eom J, Son YG, Yeom D, Sung B, Yoo M, Seo A, Yoo J, Park JY, Jung J, Ahn J, You WK, Lee SH, Ko MJ. Preclinical development of ABL206, a novel bispecific antibody-drug conjugate targeting B7-H3 and ROR1. MAbs. 2026 Dec;18(1):2731283. doi: 10.1080/19420862.2026.2731283. Epub 2026 Sep 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NEOK001 and NEOK001 RDE in people with Locally Advanced (Unresectable) or Metastatic Solid Tumors, run by NEOK Bio, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Willie J Hudson, MS (615-507-4263, whudson@neokbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs) (time frame: 21 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07612176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.