First-in-human test of CKD-703 for advanced solid tumors and non-small cell lung cancer

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 Phase 1/2a open-label, multicenter trial gives CKD‑703 to adults with advanced c‑Met–expressing solid tumors and to patients with MET‑amplified or c‑Met–overexpressing nonsquamous NSCLC after prior therapy. The study includes dose-escalation and expansion cohorts (Parts 1–3) to identify a safe dose, characterize pharmacokinetics, and observe anti-tumor activity measured by RECIST 1.1. CKD‑703 is an antibody–drug conjugate that links a c‑Met–targeting monoclonal antibody to the cytotoxic agent MMAE to deliver chemotherapy directly to c‑Met–positive cancer cells. Eligible patients must have measurable progressive disease, ECOG 0–1, and generally have failed standard approved therapies for their condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and females ≥ 19-year-old
* Part 1 : Solid tumors including NSCLC for which standard therapy has failed or was not tolerated, and no other effective therapy exists
* Part 2 : Histologically or cytologically documented c-Met overexpressing nonsquamous NSCLC having failed at least 1 line of SoC therapy (platinum-based chemotherapy and/or immune checkpoint inhibitor).
* Part 3 : Histologically or cytologically documented c-Met expressing solid tumors for which standard therapy has failed or was not tolerated.
* In all parts of the study, subjects with NSCLC with documented actionable genetic alterations must have failed at least 1 line of country-level approved targeted therapies
* Life expectancy ≥ 12 weeks as judged by the Investigator
* Documented progressive and measurable disease as defined by RECIST 1.1
* ECOG Performance Status 0 or 1

Exclusion Criteria:

* Subject has received radiation therapy to the lung \< 6 months prior to the first dose of study drug
* Prior radiotherapy to ≥ 25% of bone marrow
* Anticancer systemic therapy such as immunotherapy, biologic, cytotoxic chemotherapy, or any investigational therapy (including cell therapy or gene therapy) within a period of 28 days prior to the first dose of study drug. Any anticancer therapy small molecule (eg. kinase inhibitor) or herbal therapy within 14 days prior to the first dose of study drug
* Prior c-Met-targeted antibody therapy or any MMAE-containing ADC (prior c-Met targeting small molecules are allowed)
* Use of strong P-gp and/or CYP3A4/5 inducers within 21 days prior or strong P-gp and/or CYP3A4/5 inhibitors within 14 days prior to the first dose of study drug
* Use of sensitive CYP3A4/5 substrate within 3 days or 5 times half-life prior to the first dose of study drug.
* Evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis that required treatment with systemic steroids within 12 months of the planned first dose of the study drug
* History of drug induced interstitial lung disease
* Prior or active ocular or corneal disease based on ophthalmic evaluation (slit lamp and visual acuity)
* Prior Grade 3 neuropathy or chronic Grade 2 neuropathy

Where it's running

• Gabrail Cancer Center
  Ohio City, Ohio, United States Recruiting

Similar studies

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

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• KQB368 as a single-drug treatment for adults with advanced solid tumors

  This study tests whether taking KQB368 by mouth every day can help shrink tumors and is safe for adults with advanced solid cancers.

  Recruiting at 14 sites Phase 1 Kumquat Biosciences Inc. · Los Angeles, California and 13 other locations · NCT07542704

• FL-261 imaging to detect and stage c-MET–expressing cancers

  This first-in-human test uses FL-261 labeled for PET or SPECT to see if it safely highlights c-MET–positive tumors in adults with advanced solid tumors such as non-small cell lung, colorectal, or head and neck cancer.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07510321

• Combination of YL201 and ivonescimab (AK112) for advanced solid tumors

  This trial will test whether combining YL201 and ivonescimab (AK112) helps people with advanced solid tumors, including non‑small cell and small cell lung cancer.

  Recruiting Phase 1/2 MediLink Therapeutics (Suzhou) Co., Ltd. · Guangzhou, Guangdong · NCT07208773

• YL202 combined with immunotherapy or targeted therapy for advanced solid tumors

  This trial tests whether adding YL202 to other anti-tumor treatments helps adults with advanced solid tumors (including breast cancer and non‑small cell lung cancer) tolerate therapy and control tumor growth.

  Recruiting Phase 1/2 MediLink Therapeutics (Suzhou) Co., Ltd. · Hefei, Anhui and 19 other locations · NCT07169994

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

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.