A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorChong Kun Dang Pharmaceutical
About this trial
This is a Phase 1/2a open-label multicenter study to evaluate the safety, efficacy, and pharmacokinetics of CKD-703 in Advanced c-Met Expressing Solid Tumors, and in MET-Amplified and c-Met Overexpressing Non-Small Cell Lung Cancer.
CKD-703 is composed of a c-Met-targeting monoclonal antibody (mAb) coupled to a cytotoxic payload consisting of the anti-microtubule drug monomethyl auristatin E (MMAE); thus, CKD-703 is a novel ADC offering a highly targeted approach with potential improvement of efficacy while reducing off-target effects for patients with NSCLC and other cancers.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- CKD-703
Treatment groups
140 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov