Targeted cancer therapy using NEOK002 for select solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label, multicenter dose-escalation and expansion study of NEOK002, a bispecific EGFR and MUC1 exatecan antibody-drug conjugate. It aims to determine the safe dose and expand findings in subsets of patients with select solid tumors that have no standard therapy options. The trial includes a Dose Escalation and Backfill portion followed by a Dose Expansion portion, with intravenous administration on each cycle. Eligibility requires measurable disease, good performance status, and adequate organ function, among other criteria.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Participants must have locally advanced or metatstatic 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.
* Participant 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.

Where it's running

• Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona DDU
  Orlando, Florida, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Sarah Cannon Research Institute Oncology Partners
  Nashville, Tennessee, United States Recruiting
• NEXT Oncology
  Austin, Texas, United States Recruiting
• Sarah Cannon Research Institute at Mary Crowley
  Dallas, Texas, United States Recruiting
• NEXT Oncology
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Beth Lepping, RN, BSN, MS
• Email: blepping@neokbio.com
• Phone: please use email

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Test a combination of SSGJ-705 and SSGJ-612 (with or without chemotherapy) in advanced HER2-expressing solid cancers

  This phase 2 study tests whether SSGJ-705 plus SSGJ-612, with or without chemotherapy, can help adults with advanced HER2-expressing solid tumors like colorectal, urothelial, breast, gastric, or biliary cancers.

  Recruiting Phase 2 Shenyang Sunshine Pharmaceutical Co., LTD. · Hangzhou, Zhejiang · NCT07646626

• NEOK001: a new B7-H3 and ROR1-targeting cancer treatment given by IV infusion

  This early-phase study tests NEOK001, a bispecific antibody-drug conjugate, in people with locally advanced or metastatic solid tumors to see if it is safe and how it behaves in the body.

  Recruiting at 9 sites Phase 1 NEOK Bio, Inc. · New York, New York and 8 other locations · NCT07612176

• Evaluating TXN10128 for patients with solid tumors

  This study is testing a new treatment called TXN10128 to see if it's safe and effective for people with advanced solid tumors, both on its own and when combined with other cancer drugs.

  Recruiting at 6 sites Phase 1 Txinno Bioscience Inc. · Seongnam-si, Gyeonggi-do and 5 other locations · NCT05978492

• SG1906 treatment for certain solid tumors

  This study is testing a new treatment called SG1906 for people with certain hard-to-treat solid tumors to see if it is safe and effective.

  Recruiting at 9 sites Phase 1 Hangzhou Sumgen Biotech Co., Ltd. · Beijing, Beijing Municipality and 8 other locations · NCT05857332

• Testing IBI354 in patients with advanced solid tumors

  This study is testing a new drug called IBI354 to see if it is safe and effective for people with advanced solid tumors that can't be removed by surgery.

  Recruiting at 2 sites Phase 1/2 Innovent Biologics (Suzhou) Co. Ltd. · Randwick, New South Wales and 5 other locations · NCT05636215

• Testing IBI343 in patients with advanced solid tumors

  This study is testing a new drug called IBI343 to see if it is safe and effective for people with advanced solid tumors that can't be removed by surgery.

  Recruiting at 38 sites Phase 1 Innovent Biologics (Suzhou) Co. Ltd. · Austin, Texas and 38 other locations · NCT05458219

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.