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NCT Number: NCT07215637

Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors

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.

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Key information

Conditions

Advanced Solid Tumors Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location status: Recruiting

Location contact

Severance Hospital, Yonsei University Health System

CONTACT

82-2-2228-1004

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CKD-512

Drug

Orally administered BID

Pembrolizumab

Combination Product

Intravenous (IV) Infusion

Primary outcomes

  1. Part A: Maximum tolerated dose (MTD) or Optimal biologically effective dose (OBED)

    Time frame: Up to 2 years

    Number and proportion of subjects who experience at least 1 DLT based on incidence, nature, and severity of TEAEs and SAEs graded according to NCI-CTCAE version 5.0 as well as on changes from baseline assessments.

  2. Part B: Recommended dose for expansion (RDE)

    Time frame: Up to 2 years

    Number and proportion of subjects who experience at least 1 DLT based on incidence, nature, and severity of TEAEs and SAEs graded according to NCI-CTCAE version 5.0 as well as on changes from baseline assessments.

Secondary outcomes

  1. Safety and tolerability

    Time frame: Up to 2 years

    Incidence and severity of TEAEs, incidence of SAEs and TRAEs etc. according to the NCI-CTCAE version 5.0

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to 2 years

    Cmax is defined as the maximum observed plasma concentration of CKD-512

  3. Cmax at steady state (Cmax_ss)

    Time frame: Up to 2 years

    Cmax_ss is defined as the maximum observed plasma concentration of CKD-512 at steady state

  4. Area Under the Curve to the last measurable concentration (AUClast)

    Time frame: Up to 2 years

    AUClast is defined as the area under the plasma concentration-time curve of CKD-512 from the time of dosing to the time of the last measurable concentration.

  5. Area Under the Curve over the dosing interval tau (AUCtau)

    Time frame: Up to 2 years

    AUCtau is defined as the area under the plasma concentration-time curve of CKD-512 over a dosing interval (tau), usually at steady state.

  6. Overall Response Rate (ORR)

    Time frame: Up to 2 years

    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  7. Duration of Response (DOR)

    Time frame: Up to 2 years

    DOR is defined as the time from the date of the first documented objective tumor response (CR or PR) assessed according to RECIST or iRECIST criteria, until the date of the first documented disease progression or death from any cause, whichever occurs first.

  8. Disease Control Rate (DCR)

    Time frame: Up to 2 years

    DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD), assessed according to RECIST version 1.1 or iRECIST criteria.

  9. Progression-Free Survival (PFS)

    Time frame: Up to 2 years

    PFS is defined as the time from the date of treatment initiation to the date of the first documented disease progression or death from any cause, whichever occurs first, assessed according to RECIST version 1.1 or iRECIST criteria.

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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