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RecruitingInterventionalPhase 1

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

NCT ID: NCT07612176Sponsor: NEOK Bio, Inc.Last updated: 2026-05-28

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).

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.

Arms & interventions

  • DrugNEOK001

    Escalating doses of NEOK001

  • DrugNEOK001 RDE

    Recommended Dose of NEOK001 for Expansion

Outcome measures

Primary

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

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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.

    Time frame: Through study completion, estimated as 32 months

Secondary

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (8)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Not Yet Recruiting
Jamie Walters · Contact

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting
Tracey Zimmer · Contact

NEXT Oncology

Austin, Texas, 78758

Not Yet Recruiting
Heather Watson · Contact

NEXT Oncology

Dallas, Texas, 75039

Not Yet Recruiting
Mofopefoluwa "Fope" Akinwale · Contact

MD Anderson Cancer Center

Houston, Texas, 77030

Not Yet Recruiting
Romeena Momin · Contact

NEXT Oncology

Houston, Texas, 77054

Not Yet Recruiting

NEXT Oncology

San Antonio, Texas, 78299

Recruiting

NEXT Oncology

Fairfax, Virginia, 22031

Not Yet Recruiting
Maybelle De La Rosa · Contact
A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors | Cancerify