A Study of MAX-40279combined With KN046 in Patients With Advanced / Metastatic Solid Tumors
NCT05425602 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2022-06-21
Summary
This include two parts, Stage 1 is a dose climbing study and Stage 2 is a dose extending study.
Conditions
- Advanced / Metastatic Solid Tumors
Interventions
- DRUG
-
MAX-40279-01: 50mg/70mg
\[Stage 1\]The starting dose of MAX-40279 was 35 mg BID, and three dose levels were initially set: 35 mg, 50 mg, and 70 mg administered twice daily (BID) continuously, and the dose of KN046 was 5 mg/kg as a fixed dose administered every 3 weeks. \[Stage 2\]When the RP2D dose is obtained in the dose-finding phase, the trial will enter the dose expansion phase.
Sponsors & Collaborators
-
Maxinovel Pty., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-31
- Primary Completion
- 2023-12-30
- Completion
- 2024-12-30
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