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New treatment option for Advanced Solid Tumors
Official title Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07215637
What this study is testing
What is CKD-512?
CKD-512 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Prior treatment with investigational agents ≤21 days before the first dose of study drug(s).
See the full eligibility 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
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.