A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

Part of paid clinical trials in New York, New York.

Sponsor
Avacta Life Sciences Ltd
Study ID
NCT04969835
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AVA6000 — DRUG
    AVA6000 is a FAP-activated doxorubicin.

Study Details

This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.

Key Dates

Start date
Jul 16, 2021
Status verified
May 2026
Primary completion
Jun 15, 2026
Completion
Aug 15, 2026

Study Design

Enrollment
158 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AVA6000 Phase 1a Dose Escalation Q3W
    Patients in this arm will receive escalating doses of AVA6000 following a 3+3 design, Q3W 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 1a Dose Escalation Q2W
    Patients in this arm will receive escalating doses of AVA6000 following a 3+3 design, Q2W 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 Dose Expansion
    Patients in this arm will receive AVA6000 at the recommended dose for expansion, until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first.
  • Experimental: AVA6000 Phase 1b Dose Expansion (dose identification)
    Dosing on this arm will occur at RDE -1 to identify the optimal biologic dose of AVA6000. Patients on this arm will receive AVA6000 until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first.

Primary Outcome Measure

Dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days after the first dose of study therapy ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Dr William Tap (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer CenterSeattleWashington98109
Dr Jennifer Specht (PRINCIPAL_INVESTIGATOR)

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Memorial Sloan Kettering Cancer Center· New York, NYUniversity of Texas MD Anderson Cancer Center· Houston, TXFred Hutchinson Cancer Center· Seattle, WA

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