This is an open-label, nonrandomized, multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MK-6204 as monotherapy in participants with advanced solid tumors.
This is an open-label, nonrandomized, multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MK-6204 as monotherapy in participants with advanced solid tumors. The primary objectives are to evaluate the safety and tolerability of MK-6204. The secondary endpoints include PK parameters, ORR, DOR, and immunogenicity of MK-6204. The study will include a Screening Phase, a Treatment Phase, and a Post-treatment Follow up Phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
MK-6204 (SKB535) for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
Beijing Cancer Hospital
Beijing, China
RECRUITINGHunan Cancer Hospital
Changsha, China
NOT_YET_RECRUITINGWest China Hospital of Sichuan University
Chengdu, China
Dose Limiting Toxicities (DLT)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during the evaluation period and is at least possibly related to study drug.
Time frame: From the date of first dose until up to 21 days of intervention
Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention.
Time frame: From the date of first dose until up to 30 days after the last dose of intervention
Serious Adverse Event (SAE)
An SAE is defined as any serious untoward medical occurrence that meets the pre-specified criteria in the protocol
Time frame: From the date of first dose until up to 30 days after the last dose of intervention
PK parameter AUC
PK parameter AUC after single and multiple doses
Time frame: Through study completion, an average of 2 years
PK parameter Cmax
PK parameter Cmax after single and multiple doses
Time frame: Through study completion, an average of 2 years
PK parameter Cmin
PK parameter Cmin after single and multiple doses
Time frame: Through study completion, an average of 2 years
Objective response rate (ORR)
ORR refers to the proportion of participants who have achieved confirmed complete response (CR) or partial response (PR).
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Chongqing University Cancer Hospital
Chongqing, China
NOT_YET_RECRUITINGFujian Provincial Cancer Hospital
Fuzhou, China
NOT_YET_RECRUITINGShanghai East Hospital
Shanghai, China
NOT_YET_RECRUITINGHubei Cancer Hospital
Wuhan, China
NOT_YET_RECRUITINGTime frame: Through study completion, an average of 2 years
Duration of response (DOR)
DOR refers to the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Through study completion, an average of 2 years
Immunogenicity of MK-6204
ADA incidence
Time frame: Through study completion, an average of 2 years