RE: AVA6000 for the treatment of soft tissue sarcoma.6 Apr 2023 10:31
Intervention Model Description: This Phase I study will follow a standard 3+3 design in Part 1a to determine the maximum tolerated dose (MTD) and/or recommended dose of AVA6000, given as an intravenous infusion, to be used in Part 1b in the dose-expansion phase in up to 3 tumour types.
Experimental: AVA6000 Phase 1a
Patients in Phase Ia will receive escalating doses of AVA6000 following a 3+3 design, commencing with a starting dose of 80mg/m2, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first.
Experimental: AVA6000 Phase 1b
Patients in Phase Ib will receive the RP2D dose of AVA6000, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first. One to three tumour types will be selected based on the assessment of Phase 1a data.
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : June 30, 2023
https://clinicaltrials.gov/ct2/show/NCT04969835