A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combi
This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended
| Condition(s) | Advanced or Metastatic Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards. |
| Who can participate | Inclusion Criteria: 1. Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard of care, no further standard can be used, or standard of care is not fit; 2. Eastern cooperative oncology grous performance status of 0-1; 3. Has at least 1 measurable lesion per RECIST 1.1; 4. Has adequate organ and bone marrow function as per study which including hemoglobin \> 90 g/L, platelet count \>=100\*10e9/L, absolute meutrophil count \>=1.5\*10e9/L; 5. Life expectancy of at least 3 months; 6. Provision of signed and dated written inform consent prior to any study-related procedures, sampling and analyses. Exclusion Criteria: 1. Active known second malignancy except adequately treated basal cell carcinoma, squamous cell skin can |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Kangabio AUSTRALIA LTD PTY |
| Locations | Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China; Shanghai, Shanghai Municipality, China |
| Start date | 2024-11-27 |
| NCT ID | NCT07260305 |
| Official listing | https://clinicaltrials.gov/study/NCT07260305 |