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A Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors

ConditionLocally Advanced (Unresectable) or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNEOK Bio, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • NEOK001

    Drug

    Escalating doses of NEOK001

  • NEOK001 RDE

    Drug

    Recommended Dose of NEOK001 for Expansion

Treatment groups

155 Participants
are divided into 2 treatment groups
Group A: Dose EscalationExperimental treatment 1 intervention
Group B: ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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 outcomes

1

Part B: Incidence of AEs

Incidence of TEAEs and SAEs in participants in Part B

Time frame
Through study completion, estimated as 32 months
2

Maximum Concentration (Cmax)

Assessment of plasma pharmacokinetics (PK) of NEOK001 maximum observed concentration (Cmax) of NEOK001.

Time frame
21 days
3

Terminal Elimination Half Life (T1/2)

Assessment of plasma PK of NEOK001 terminal elimination half-life (T1/2).

Time frame
21days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NEOK Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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