NCT07215637

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
16mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Oct 2025Sep 2027

First Submitted

Initial submission to the registry

September 24, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 10, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

October 16, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 2, 2026

Status Verified

October 1, 2025

Enrollment Period

1.4 years

First QC Date

September 24, 2025

Last Update Submit

January 29, 2026

Conditions

Advanced Solid TumorsMetastatic Solid Tumors

Keywords

A2aRadenosine A2A receptorCKD-512Advanced Solid TumorsMetastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 2 years

  • 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.

    Up to 2 years

Secondary Outcomes (9)

  • Safety and tolerability

    Up to 2 years

  • Maximum Observed Plasma Concentration (Cmax)

    Up to 2 years

  • Cmax at steady state (Cmax_ss)

    Up to 2 years

  • Area Under the Curve to the last measurable concentration (AUClast)

    Up to 2 years

  • Area Under the Curve over the dosing interval tau (AUCtau)

    Up to 2 years

  • +4 more secondary outcomes

Study Arms (2)

Part A: Monotherapy

EXPERIMENTAL

Dose Level(DL) 1 to DL 6

Drug: CKD-512

Part B: Combination therapy

EXPERIMENTAL

DL N to DL N+2, combination with Pembrolizumab

Drug: CKD-512Combination Product: Pembrolizumab

Interventions

CKD-512DRUG

Orally administered BID

Part A: MonotherapyPart B: Combination therapy
PembrolizumabCOMBINATION_PRODUCT

Intravenous (IV) Infusion

Part B: Combination therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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.
  • Adequate clinical laboratory values and other measures

You may not qualify 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 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 10, 2025

Study Start

October 16, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

February 2, 2026

Record last verified: 2025-10

Locations

KR(1)