Actively Recruiting
A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of MK-6204 (SKB535) for Injection in Participants With Advanced Solid Tumors
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-07
90
Participants Needed
7
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of MK-6204 (SKB535) for Injection in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically or cytologically confirmed advanced/metastatic solid tumor including colorectal cancer, gastric or gastroesophageal junction adenocarcinoma, esophageal carcinoma, pancreatic cancer, non-small cell lung cancer, cervical carcinoma, or head and neck squamous cell carcinoma
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Provided documented informed consent
- Agree to provide archival or new tumor biopsy samples
- Recovered to Grade 1 or baseline from adverse events due to previous anticancer therapies; endocrine-related adverse events controlled with hormone replacement; neuropathy Grade 2 or lower
You will not qualify if you...
- Active severe digestive diseases such as gastric outlet obstruction, persistent vomiting, severe gastrointestinal hemorrhage, gastric or duodenal ulcers, acute gastrointestinal perforation, acute necrotizing pancreatitis, ulcerative enteritis, congenital megacolon, or Crohn's disease
- History or current interstitial lung disease or noninfectious pneumonitis requiring steroids, or suspected lung inflammation not ruled out by imaging
- Use of strong CYP3A4 inhibitors or inducers within 2 weeks before first dose or within 5 half-lives of drug elimination
- Use of strong breast cancer resistance protein inhibitors within 2 weeks before first dose or within 5 half-lives of drug elimination
- Prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives before intervention
- Known progressing additional malignancy requiring treatment within the past 2 years
- Active CNS metastases or carcinomatous meningitis; stable treated brain metastases allowed if no progression for at least 4 weeks and no steroid treatment for at least 14 days before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, China, 410031
Not Yet Recruiting
3
West China Hospital of Sichuan University
Chengdu, China
Not Yet Recruiting
4
Chongqing University Cancer Hospital
Chongqing, China
Not Yet Recruiting
5
Fujian Provincial Cancer Hospital
Fuzhou, China
Not Yet Recruiting
6
Shanghai East Hospital
Shanghai, China
Not Yet Recruiting
7
Hubei Cancer Hospital
Wuhan, China
Not Yet Recruiting
Research Team
L
Lin Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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