Study on AdAPT-001 for Patients with Sarcoma and Hard-to-Treat Solid Tumors

Sponsor: EpicentRx, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04673942

Provider View

This clinical trial is testing a new treatment called AdAPT-001, an oncolytic virus, to see if it is safe and can be tolerated by patients with sarcoma and other solid tumors that have not responded to standard treatments.

Patient Parameters

Program Overview

AdAPT-001 is a type of virus designed to attack cancer cells. It is given directly into the tumor or through an artery. The study aims to find out if AdAPT-001 is safe and if it works well, either alone or with another type of cancer treatment called a checkpoint inhibitor.

Description

This study is being conducted in phases to determine the safety and effectiveness of AdAPT-001, a virus-based treatment for cancer. The study has three parts:

  • Phase 1 Part 1 (Closed): Participants received a single injection of AdAPT-001 to find the highest safe dose.
  • Phase 1 Part 2 (Closed): Participants received AdAPT-001 injections on Days 1 and 15 of a 28-day cycle.
  • Phase 1 Part 3 (Closed): Participants were divided into two groups. One group received AdAPT-001 alone, and the other received AdAPT-001 with a checkpoint inhibitor.

Phase 2 (Open to Enrollment):

  • Participants with advanced solid tumors will be divided into two groups based on their cancer type.
    • Group 1: Patients with sarcoma will receive AdAPT-001 injections, with or without a checkpoint inhibitor.
    • Group 2: Patients with other advanced solid tumors will receive AdAPT-001 and at least one checkpoint inhibitor.

Eligibility Criteria

Inclusion Criteria

  • Must understand the study and provide written consent.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of an advanced solid tumor that is accessible for treatment.
  • Must have a good performance status (ECOG 0-1).
  • Must have acceptable liver function based on specific blood tests.
  • Must have acceptable kidney function.
  • Must have acceptable blood cell counts.
  • Must have a normal blood clotting time.
  • Women of childbearing potential and men with partners of childbearing potential must use effective contraception during the study and for four weeks after the last dose.
  • Must be willing to follow all study procedures and visits.
  • Optional: Provide previous tumor samples if available.

Exclusion Criteria

  • Have a serious medical condition or lab finding that suggests an untreated disorder.
  • Have an uncontrolled active infection.
  • Have a history of HIV.
  • Have active hepatitis.
  • If female, must not be pregnant or breastfeeding.
  • Have an active autoimmune disease or history of one that could affect vital organs or require immune-suppressing treatment.
  • Have had prior adenoviral therapy, except for certain vaccinations.
  • Have had chemotherapy or immunotherapy within 14 days of starting the study treatment. Hormonal therapy is allowed.

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