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Advanced Solid TumorsPhase 1NCT07215637

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

A Phase 1 study testing CKD-512 and Pembrolizumab in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CKD-512 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
16 Oct 2025to Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul

    Severance Hospital, Yonsei University Health System, 82-2-2228-1004

    Recruiting

Other trials in South Korea

About this study

Official 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

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.

Being tested
CKD-512, Pembrolizumab
Keywords
A2aR, adenosine A2A receptor, CKD-512, Advanced Solid Tumors, Metastatic Solid Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-512Drug

    Orally administered BID

  • PembrolizumabCombination product

    Intravenous (IV) Infusion

Study groups in NCT07215637
Study groupRoleWhat they receive
Part A: MonotherapyExperimentalDose Level(DL) 1 to DL 6
Receives: Drug: CKD-512
Part B: Combination therapyExperimentalDL N to DL N+2, combination with Pembrolizumab
Receives: Drug: CKD-512; Combination Product: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Up to 2 years

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

    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.

    Measured: Up to 2 years

Secondary outcomes (9)

  1. Safety and tolerability

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

    Measured: Up to 2 years

  2. Maximum Observed Plasma Concentration (Cmax)

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

    Measured: Up to 2 years

  3. Cmax at steady state (Cmax_ss)

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

    Measured: Up to 2 years

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

    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.

    Measured: Up to 2 years

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

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

    Measured: Up to 2 years

  6. Overall Response Rate (ORR)

    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.

    Measured: Up to 2 years

  7. Duration of Response (DOR)

    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.

    Measured: Up to 2 years

  8. Disease Control Rate (DCR)

    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.

    Measured: Up to 2 years

  9. Progression-Free Survival (PFS)

    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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2025
  2. Study start16 Oct 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215637
Sponsor's protocol ID
A150_01ST2410
Status last verified
Oct 2025
First submitted
24 Sep 2025
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-512 and Pembrolizumab in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Maximum tolerated dose (MTD) or Optimal biologically effective dose (OBED) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07215637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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