AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Avacta Life Sciences Ltd
Study ID
NCT07454642
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Colorectal Cancer
  • GEJ Adenocarcinoma
  • Gastric Adenocarcinoma
  • Hormone Receptor Positive Breast Carcinoma
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Small Cell Carcinoma of Lung
  • Vulvar Adenocarcinoma

Eligibility Criteria

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

Interventions

  • AVA6103 — DRUG
    AVA6103 is a FAP-activated Exatecan

Study Details

This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors 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
Mar 31, 2026
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
174 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AVA6103 Phase 1a Dose Escalation Q3W
    Patients in this arm will receive escalating doses of AVA6103 Q3W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first.
  • Experimental: AVA6103 Phase 1a Dose Escalation Q2W
    Patients in this arm will receive escalating doses of AVA6103 Q2W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first.
  • Experimental: AVA6103 Phase 1b Dose Expansion
    Patients in this arm will receive AVA6103 at the recommended phase 2 dose, until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first.

Primary Outcome Measure

Adverse events (AEs) [ Time Frame: From Day 1 until up to 30 days after last dose of study drug. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
START MidwestGrand RapidsMichigan49546
Ronan Pleass
[email protected]
NEXT OncologyIrvingTexas75039
Mofopefoluwa Akinwale
[email protected]
(972) 893-8800
NEXT Oncology VirginiaFairfaxVirginia22031
Maybelle De La Rosa
[email protected]
(703) 783-4518

Find similar trials in Grand Rapids, MI

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
START Midwest· Grand Rapids, MINEXT Oncology· Irving, TXNEXT Oncology Virginia· Fairfax, VA

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