CKD-512 alone and with pembrolizumab for advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Severance Hospital, Yonsei University Health System
  Seoul, South Korea Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TROP2-targeted CAR-NK cell therapy for advanced solid tumors

  This study tests EB-NK-301, an off-the-shelf CAR-NK cell therapy, in adults with advanced or metastatic TROP2-expressing solid tumors after standard treatments have failed.

  Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07589530

• Combining RAS(ON) inhibitors with ivonescimab for adults with RAS‑mutant advanced solid tumors

  This trial will test whether combining RAS(ON) inhibitors with ivonescimab is safe and can shrink or control tumors in adults with advanced or metastatic solid tumors that have RAS mutations.

  Recruiting at 19 sites Phase 1/2 Revolution Medicines, Inc. · Scottsdale, Arizona and 18 other locations · NCT07397338

• EIK1005 (Werner helicase inhibitor) alone or with pembrolizumab for advanced MSI-H/dMMR and other solid tumors

  This trial tests whether EIK1005, given alone or together with pembrolizumab, can be safely given and help people with advanced solid tumors, especially MSI‑H/dMMR cancers.

  Recruiting at 44 sites Phase 1/2 Eikon Therapeutics · Los Angeles, California and 44 other locations · NCT07262619

• ABX-001 alone or with pembrolizumab for advanced solid tumors

  This tests whether the new immunotherapy ABX-001, given alone or with pembrolizumab, is safe and shows signs of benefit in adults with advanced solid tumors that have stopped responding to prior treatments.

  Recruiting at 5 sites Phase 1 Abalos Therapeutics GmbH · Berlin and 4 other locations · NCT07231458

• Combining PYX-201 with Pembrolizumab for Advanced Solid Tumors

  This study is testing a new combination of two cancer treatments, PYX-201 and pembrolizumab, to see how well they work and how safe they are for people with advanced solid tumors like certain types of breast and head and neck cancers.

  Recruiting at 22 sites Phase 1/2 Pyxis Oncology, Inc · San Diego, California and 21 other locations · NCT06795412

• Evaluating ODC-IL2 for advanced or metastatic solid tumors

  This study is testing a new treatment called ODC-IL2 to see if it is safe and can help adults with advanced or metastatic solid tumors.

  Recruiting Phase 1 Trutino Biosciences Inc. · Scottsdale, Arizona · NCT06770764

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.