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A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer

ConditionsAdvanced Solid TumorsNon-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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • CKD-703

    Drug

    Intravenous (IV) Infusion

Treatment groups

140 Participants
are divided into 3 treatment groups
Group A: Part 1Experimental treatment 1 intervention
Group B: Part 2Experimental treatment 1 intervention
Group C: Part 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of patients with dose limiting toxicity (DLT)

Collect all adverse events at each visit

Time frame
first 21-day period of therapy
2

Part 2 and Part 3: Object Response Rate (ORR)

ORR defined as the proportion of subjects with a best Investigator-assessed confirmed objective response of CR or PR according to RECIST 1.1

Time frame
Up to 24 months

Secondary outcomes

1

All parts : Treatment-Emergent Adverse Events (TEAE)

Incidence of SAEs, SUSARs, TEAEs, and AESI

Time frame
Up to 24 months
2

All parts : Immunogenicity (ADA)

Blood samples were collected and assessed by validated immunoassays for immunogenicity of CKD-703, including the incidence of anti-drug antibodies (ADA)

Time frame
Up to 24 months
3

All parts : Immunogenicity (NAb)

Blood samples were collected and assessed by validated immunoassays for immunogenicity of CKD-703, including the incidence of neutralizing antibodies (NAb)

Time frame
Up to 24 months
4

Part 1 and Part 2 : Pharmacokinetic parameter

CKD-703 (conjugated antibody)

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chong Kun Dang Pharmaceutical

Lead sponsor

Source ClinicalTrials.gov
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