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.
≥ 18 years of age
Have a histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have failed or do not have available standard treatments. The tumor types will be limited to: CRC; Gastric carcinoma or gastroesophageal junction (GEJ) adenocarcinoma; Esophageal carcinoma; Pancreatic cancer; NSCLC; Cervical carcinoma; Head and Neck squamous cell carcinoma.
Have measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Target lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
Have a performance status of 0 or 1 on the ECOG Performance Scale.
Active severe digestive disease, including but not limited to complete or incomplete gastric outlet obstruction, persistent/recurrent vomiting, severe gastrointestinal hemorrhage, gastric or duodenal ulcers, acute gastrointestinal perforation, acute necrotizing pancreatitis, ulcerative enteritis, congenital megacolon, or Crohn's disease.
Participants with a history of interstitial lung disease (ILD) or a history of noninfectious pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Received strong cytochrome P450 (CYP3A4) inhibitors or inducers within 2 weeks prior to the first dose of study intervention or within 5 half-lives of drug elimination, whichever is longer.
Received strong breast cancer resistance protein (BCRP) inhibitors within 2 weeks prior to the first dose of study intervention or within 5 half-lives of drug elimination, whichever is longer.
Single group
MK-6204 (SKB535) for Injection
DrugMK-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.
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.
Serious Adverse Event (SAE)
An SAE is defined as any serious untoward medical occurrence that meets the pre-specified criteria in the protocol
PK parameter AUC
PK parameter AUC after single and multiple doses
PK parameter Cmax
PK parameter Cmax after single and multiple doses
PK parameter Cmin
PK parameter Cmin after single and multiple doses
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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