Trials / Completed
CompletedNCT05390710
PhI to Solid Tumors and PhII to Locally Advanced or mTNBC
A PhI Dose Escalation Study of LAE005+Afuresertib+Nab_Paclitaxel in Advanced Solid Tumors and PhII Study to Evaluate the Safety and Efficacy of LAE005+Afur+Nab_Paclitaxel or LAE005/Afur+Nab-Paclitaxel in Locally Advanced or mTNBC
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Laekna Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
PhI Dose Escalation with BOIN design in advanced Solid Tumor with Triple combination therapy to determine MTD and RP2D
Detailed description
Phase I dose escalation for triple combination therapy with BOINcomb design,The safety (including DLT), tolerability, and PK are the study endpoints of phase I and to determine MTD and RP2D.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | LAE005 + Afuresertib + Nab-Paclitaxel | LAE005: 1200 mg IV Q3W, Afuresertib: 125 mg QD, Nab paclitaxel:125 mg/m D1, D8 Q3W |
Timeline
- Start date
- 2021-06-12
- Primary completion
- 2023-12-11
- Completion
- 2023-12-11
- First posted
- 2022-05-25
- Last updated
- 2024-10-10
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05390710. Inclusion in this directory is not an endorsement.