A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of MK-6
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.
| Condition(s) | Advanced Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. ≥ 18 years of age 2. 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. 3. 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. 4. Have a performance status of 0 or 1 on the ECOG Performance Scale. 5. The participant has provided documented informed consent for the study. 6. Part |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Locations | Beijing, China; Changsha, China; Chengdu, China; Chongqing, China; Fuzhou, China; Shanghai, China (+1 more sites) |
| Start date | 2024-12-12 |
| NCT ID | NCT06726369 |
| Official listing | https://clinicaltrials.gov/study/NCT06726369 |