A Phase 1 interventional study of MK-6204 (SKB535) for Injection in Advanced Solid Tumors, sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. Recruiting at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is the lead sponsor of 55 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Several dose levels of MK-6204 (SKB535) for Injection are planned and administered every 3 weeks.
Drug: MK-6204 (SKB535) for Injection
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.
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).
Time 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
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.