NCT07215637 Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors
| NCT ID | NCT07215637 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chong Kun Dang Pharmaceutical |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-10-16 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this first-in-human (FiH) study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CKD-512 given alone and in combination with pembrolizumab in subjects with advanced or metastatic solid tumors who have failed all standard available therapy.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed advanced or metastatic solid tumors. * Progressive disease after or intolerance to standard therapy and no other effective therapeutic options available. * Measurable disease as defined in Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Suitable venous access for the study-required blood sampling, including PK and PD sampling. * Adequate clinical laboratory values and other measures Exclusion Criteria: * Active disease involvement of the central nervous system. * Any serious or life-threatening medical condition unrelated to cancer, psychiatric illness, drug or alcohol abuse, that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol. * Systemic anticancer treatment within the protocol-specified period prior to the first dose. * History of any immune-related toxicity that lead to permanent discontinuation of prior anticancer therapy * Radiation therapy on a limited area is allowed until 4 weeks prior to the first dose of study drug, provided that the radiated lesion is clinically stable. * Prior treatment with investigational agents ≤21 days before the first dose of study drug(s).
Frequently Asked Questions
Who can join the NCT07215637 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07215637 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07215637 currently recruiting?
Yes, NCT07215637 is actively recruiting participants. Visit ClinicalTrials.gov or contact Chong Kun Dang Pharmaceutical to inquire about joining.
Where is the NCT07215637 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07215637 clinical trial?
NCT07215637 is sponsored by Chong Kun Dang Pharmaceutical. The trial plans to enroll 60 participants.