Avacta Begins Phase 1 Trial of FAP-Exd Cancer Drug Candidate

First patient treated in FOCUS-01 study of sustained-release pre|CISION® peptide drug conjugate

Mar. 31, 2026 at 7:03am

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Avacta Therapeutics has dosed the first patient in the Phase 1 FOCUS-01 clinical trial of its FAP-Exd (AVA6103) cancer drug candidate. The open-label trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AVA6103 in patients with advanced solid tumors including pancreatic, cervical, gastric, and small cell lung cancers.

Why it matters

Avacta's pre|CISION® platform is designed to selectively deliver highly potent cancer payloads to the tumor microenvironment while minimizing systemic toxicity. The FOCUS-01 trial will test the company's second-generation sustained-release mechanism, which aims to provide prolonged exposure of the drug payload within the tumor.

The details

The Phase 1a dose escalation portion of the FOCUS-01 trial will enroll approximately 144 patients across four solid tumor types. The study will use a Bayesian statistical method to identify the optimal dose and regimen for further development. The first three clinical sites are located in Virginia, Texas, and Michigan.

  • The first patient was dosed on March 31, 2026.
  • Initial data from the FOCUS-01 trial is expected later this year.

The players

Avacta Therapeutics

A clinical-stage biopharmaceutical company developing the pre|CISION® tumor-activated oncology delivery platform.

FAP-Exd (AVA6103)

Avacta's second clinical candidate, a pre|CISION® peptide drug conjugate that utilizes a sustained-release mechanism to deliver a cancer payload directly to the tumor.

FOCUS-01 Trial

The Phase 1 clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of FAP-Exd (AVA6103) in patients with advanced solid tumors.

Alexander Spira, MD, PhD, FACP, FASCO

Co-Director of the Virginia Cancer Specialists (VCS) Research Institute and a lead investigator on the FOCUS-01 trial.

Christina Coughlin, CEO

The CEO of Avacta Therapeutics who commented on the milestone of dosing the first patient in the FOCUS-01 trial.

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What they’re saying

“Targeting a potent topoisomerase I inhibitor specifically to the tumor, and thereby minimizing damage to healthy cells, potentially marks a significant advance in cancer care. We're excited to work with Avacta and join this Phase 1 trial for AVA6103 and to bring this cutting-edge approach into reality and improve treatment options for patients in need.”

— Alexander Spira, MD, PhD, FACP, FASCO, Co-Director, Virginia Cancer Specialists (VCS) Research Institute

“We are maintaining our momentum with both a successful fundraise and a critical trial opening for patients, which is expected to demonstrate the benefits of the pre|CISION® Gen Two sustained release mechanism of our second pipeline asset, AVA6103.”

— Christina Coughlin, CEO, Avacta Therapeutics

What’s next

The FOCUS-01 trial is designed to identify a dose and regimen for further clinical development of FAP-Exd (AVA6103) using a Bayesian statistical method.

The takeaway

Avacta's pre|CISION® platform aims to selectively deliver highly potent cancer payloads to the tumor while minimizing systemic toxicity, potentially unlocking the full potential of cancer therapies. The FOCUS-01 trial of FAP-Exd (AVA6103) represents an important step in advancing this innovative approach.