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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-16

Study Completion Date

2027-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Advanced Solid Tumors Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Monotherapy

Dose Level(DL) 1 to DL 6

Group Type EXPERIMENTAL

CKD-512

Intervention Type DRUG

Orally administered BID

Part B: Combination therapy

DL N to DL N+2, combination with Pembrolizumab

Group Type EXPERIMENTAL

CKD-512

Intervention Type DRUG

Orally administered BID

Pembrolizumab

Intervention Type COMBINATION_PRODUCT

Intravenous (IV) Infusion

Interventions

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CKD-512

Orally administered BID

Intervention Type DRUG

Pembrolizumab

Intravenous (IV) Infusion

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No