NEOK002 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, NEOK002, for individuals with certain advanced solid tumors lacking standard treatment options. The goal is to determine the optimal dose of NEOK002 and evaluate its effectiveness in these cancers. Suitable candidates for this trial have a measurable tumor that has progressed and currently lack other standard treatments. Initially, the trial will test various doses and then expand to assess the effectiveness of the optimal dose. As a Phase 1 trial, this research aims to understand how NEOK002 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the 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 NEOK002 is likely to be safe for humans?
Research has shown that NEOK002 has a good safety record in early studies. Tests with monkeys demonstrated that the treatment was well tolerated even at high doses, suggesting safety at these levels. Additionally, initial studies indicated that NEOK002 reduced toxicity related to a protein called EGFR.
The treatment is now undergoing Phase 1 clinical trials, which primarily focus on safety. Reaching this stage indicates that NEOK002 has already demonstrated some safety in earlier tests. However, as this is the first time it is being tested in humans, the main goal is to assess how well people tolerate NEOK002 and identify any potential side effects.12345Why do researchers think this study treatment might be promising?
Researchers are excited about NEOK002 because it offers a new approach to cancer treatment. Unlike traditional chemotherapy that attacks rapidly dividing cells indiscriminately, NEOK002 is designed to target specific cancer pathways, potentially leading to fewer side effects. Additionally, NEOK002 is being tested in both dose escalation and expansion phases, which means researchers are fine-tuning its effectiveness and safety profile. This targeted mechanism and the ongoing optimization make NEOK002 a promising candidate in the fight against cancer.
What evidence suggests that NEOK002 might be an effective treatment for cancer?
Research has shown that NEOK002 has promising results in early studies. This treatment targets two proteins: EGFR, which aids cell growth, and MUC1, often present in cancer cells. In studies using tumors from patients, NEOK002 stopped tumor growth in all 36 tested cases and shrank tumors in 78% of them. These findings suggest that NEOK002 might effectively treat certain solid tumors by specifically attacking cancer cells while sparing healthy ones. Although these results come from early research, they provide a strong basis for further study. Participants in this trial will join either the Dose Escalation or Dose Expansion arms to further evaluate NEOK002's effectiveness and safety.12345
Are You a Good Fit for This Trial?
This trial is for adults with certain solid tumors (types of cancer) that have not responded to standard treatments or for whom no effective therapy exists. Participants must be in generally good health aside from their cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation and Backfill (Part A)
Participants receive NEOK002 to determine the recommended dose and assess dose-limiting toxicities
Dose Expansion (Part B)
Participants receive the recommended dose of NEOK002 to evaluate objective response rate and adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NEOK002
Trial Overview
The study is testing NEOK002, a new drug designed to target EGFR and MUC1 proteins found on some cancers. The trial will first find the safest dose, then test how well it works in more people with these cancers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Recommended Dose of NEOK002 for Expansion
NEOK002
Find a Clinic Near You
Who Is Running the Clinical Trial?
NEOK Bio, Inc.
Lead Sponsor
Citations
1.
aacrjournals.org
aacrjournals.org/mct/article/doi/10.1158/1535-7163.MCT-26-0088/783946/ABL209-NEOK002-Designing-an-EGFRxMUC1-bispecificABL209 (NEOK002) : Designing an EGFRxMUC1 bispecific ...
ABL209 demonstrated tumor growth inhibition across all 36 tested patient-derived xenograft models, inducing tumor regressions in 78% of models and showing ...
NEOK Bio Initiates Phase 1 Clinical Trials of Both Lead ...
NEOK002 is a novel bispecific ADC targeting EGFR epidermal growth factor receptor (EGFR) and MUC1 (Mucin 1)-expressing solid tumors. Each Phase ...
A Study of NEOK002, an EGFR and MUC1 Targeting ...
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so ...
ABL Bio
- Strong anti-tumor efficacy and favorable safety profile demonstrated in preclinical studies- Currently in Phase 1 clinical trials in the U.S.; initial ...
NEOK002 / ABL Bio, NEOK Bio
NEOK002 (ABL209): Redesigning an EGFRxMUC1 bispecific TOP1i ADC with promising anti-tumor activity and enhanced therapeutic window (AACR 2026) - "The in ...
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