Locally Advanced (Unresectable) or Metastatic Solid Tumors
Conditions
Keywords
Antibody-Drug Conjugate, ADC, Bispecific, B7-H3, ROR1, Locally Advanced, Unresectable, Metastatic, Solid Tumor, oncology
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).
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.
Interventions
DRUGNEOK001
Escalating doses of NEOK001
DRUGNEOK001 RDE
Recommended Dose of NEOK001 for Expansion
Sponsors
NEOK Bio, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose Escalation followed by Expansion
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs) | 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) | 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) | Through study completion, estimated as 32 months | Percentage of participants who achieve a confirmed objective response (ORR) |
| Part B: Duration of Response (DOR) | Through study completion, estimated as 32 months | The time from the first documentation of tumor response (complete or partial) until disease progression or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Incidence of AEs | Through study completion, estimated as 32 months | Incidence of TEAEs and SAEs in participants in Part B |
| Maximum Concentration (Cmax) | 21 days | Assessment of plasma pharmacokinetics (PK) of NEOK001 maximum observed concentration (Cmax) of NEOK001. |
| Terminal Elimination Half Life (T1/2) | 21days | Assessment of plasma PK of NEOK001 terminal elimination half-life (T1/2). |
Countries
United States
Contacts
CONTACTWillie J Hudson, MS
Outcome results
None listed