CKD-512 alone and with pembrolizumab for advanced or metastatic solid tumors
A Multicenter, Open-label, Dose-escalation, Phase Ia/Ib Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CKD-512 Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumor
This study will try CKD-512 by itself and together with pembrolizumab in people with advanced or metastatic solid tumors who have exhausted standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chong Kun Dang Pharmaceutical Industry-sponsored |
| Drugs / interventions | Radiation, pembrolizumab |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07215637 on ClinicalTrials.gov |
What this trial studies
This first-in-human, Phase Ia/Ib interventional trial tests escalating doses of CKD-512 as monotherapy and in combination with the PD-1 inhibitor pembrolizumab in adults with advanced or metastatic solid tumors. Primary goals are to define safety, tolerability, and pharmacokinetics, with pharmacodynamic markers and preliminary anti-tumor activity measured using RECIST v1.1. The trial enrolls patients with measurable disease and ECOG 0–1 who have progressed on or are intolerant to standard therapies, using dose-escalation cohorts followed by combination expansion cohorts. Study procedures include serial blood sampling for PK/PD, imaging for tumor response, and close monitoring for immune-related or other adverse events at a single site in Seoul.
Who should consider this trial
Good fit: Adults with histologically confirmed advanced or metastatic solid tumors, measurable disease per RECIST v1.1, ECOG 0–1, adequate labs, and who have progressed on or cannot tolerate standard therapies are the intended participants.
Not a fit: Patients with active central nervous system disease, uncontrolled serious medical or psychiatric conditions, recent systemic anticancer therapy within protocol-specified windows, or those who still have effective standard treatment options are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, CKD-512 alone or with pembrolizumab could provide a new treatment option that enhances anti-tumor immune responses in patients who have no standard therapies left.
How similar studies have performed: Adenosine A2A receptor antagonists have shown immune-stimulating effects in preclinical work and early-phase combination signals with PD-1 inhibitors, but large randomized successes are not yet established.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Seoul
- Severance Hospital, Yonsei University Health System — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.