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

Chong Kun Dang

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors; Metastatic Solid Tumors

Treatments: Combination Product: Pembrolizumab; Drug: CKD-512

Study type: Interventional

Funder types: Industry

Identifiers

NCT07215637

A150_01ST2410

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Part A: Monotherapy

Experimental group

Description:

Dose Level(DL) 1 to DL 6

Treatment:

Drug: CKD-512

Part B: Combination therapy

Experimental group

Description:

DL N to DL N+2, combination with Pembrolizumab

Treatment:

Drug: CKD-512

Combination Product: Pembrolizumab