155 Participants NeededMy employer runs this trial

NEOK001 for Cancer

Recruiting at 8 trial locations
WJ
Overseen ByWillie J Hudson, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, NEOK001, for certain solid tumors that have spread or cannot be removed. The goal is to determine the optimal dose and evaluate its effectiveness. The trial has two parts: one to identify the safest dose and another to test this dose more broadly. Suitable participants have a type of cancer with no current standard treatment and at least one measurable tumor. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the NEOK001 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NEOK001 is likely to be safe for humans?

Research has shown that NEOK001 is promising in terms of safety. Studies indicate it has a good safety profile, meaning most patients can handle the treatment well. In trials, NEOK001 was generally well-tolerated, which is a positive sign for safety. Although this trial marks the first time NEOK001 is tested in humans, early data from lab and animal studies are encouraging. The treatment targets specific proteins in cancer cells, allowing it to attack the cancer effectively while reducing side effects. However, since this is an early-stage trial, researchers are still studying all potential risks.12345

Why do researchers think this study treatment might be promising?

NEOK001 is unique because it targets cancer cells in a novel way, potentially offering a new mechanism of action compared to existing treatments like chemotherapy and radiation, which primarily aim to kill fast-dividing cells indiscriminately. This selective targeting could mean fewer side effects and better outcomes for patients. Researchers are excited about NEOK001 as it represents a promising shift towards more personalized and precise cancer therapies.

What evidence suggests that NEOK001 might be an effective treatment for cancer?

Research has shown that NEOK001 is a promising new treatment for certain types of cancer. This drug combines an antibody with a cancer-fighting agent, targeting two proteins, B7-H3 and ROR1, commonly found on cancer cells. In animal studies, NEOK001 stopped tumor growth in 81% of cases and caused tumors to shrink in 54% of cases. These results suggest that NEOK001 could effectively target cancer cells in humans and potentially reduce the chance of treatment resistance. This trial will include two experimental arms: a Dose Escalation arm and an Expansion arm, both evaluating the effectiveness of NEOK001 in treating solid tumors in people.34567

Are You a Good Fit for This Trial?

This trial is for adults with certain solid tumors (types of cancer) who have already tried standard treatments or have no other options. Participants need to be in generally good health aside from their cancer.

Inclusion Criteria

My blood, liver, and kidney functions are within normal limits.
I have a sample of my most recent tumor biopsy available.
I have at least one tumor that can be measured on scans.
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Exclusion Criteria

Participants with a QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec
I do not have interstitial lung disease needing steroid treatment.
I have severe lung problems or need extra oxygen, or I have had a lung removed.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Backfill (Part A)

Participants receive NEOK001 in a dose escalation format to determine the maximum tolerated dose

21 days
Multiple visits per cycle

Dose Expansion (Part B)

Participants receive NEOK001 at the determined dose to further evaluate safety and efficacy

Estimated 32 months
Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Estimated 32 months

What Are the Treatments Tested in This Trial?

Interventions

  • NEOK001

Trial Overview

The study is testing NEOK001, a new drug designed to target two proteins found on some cancers. The trial will first find the safest dose and then test how well it works in people with select solid tumors.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: ExpansionExperimental Treatment1 Intervention
Group II: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NEOK Bio, Inc.

Lead Sponsor

Citations

NEOK Bio Receives FDA IND Approval for NEOK001, A ...

NEOK001 is a bispecific ADC designed to target B7-H3 and ROR1, two surface proteins highly expressed in cancer cells. The therapy is conjugated ...

NEOK Bio Initiates Phase 1 Clinical Trials of Both Lead ...

NEOK001 is a first-in-class bispecific ADC designed to target B7-H3 and ROR1, two surface proteins highly expressed in cancer cells. NEOK002 is ...

A Phase 1 Study of NEOK001, a B7-H3 and ROR1 ...

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

Abstract 1724: NEOK001 (ABL206): A first in class B7 ...

In vivo, NEOK001 demonstrates tumor growth inhibition in 81% (n=37) and regression in 54% of PDX models across multiple tumor types including ...

ABL Bio

It demonstrated potent anti-tumor efficacy in PDX models and showed the potential to improve the therapeutic window, supported by favorable pharmacokinetics (PK) ...

NEOK Bio Receives FDA IND Approval for NEOK001, A ...

NEOK Bio Receives FDA IND Approval for NEOK001, A First-In-Class B7-H3/ROR1 Bispecific ADC for Treatment of Solid Tumor Cancers. Published : ...

NEOK Bio Receives FDA IND Approval for NEOK001, A ...

NEOK001 is a bispecific ADC designed to target B7-H3 and ROR1, two surface proteins highly expressed in cancer cells. The therapy is ...