An Adapted Phase 2a/2b, Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Subjects With Refractory Solid Tumors
EpicentRx, Inc.
Summary
AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor.
Description
This is a dose escalation protocol to determine, first and foremost, the safety, tolerability and feasibility of intratumoral administration of AdAPT-001. The study has 3 parts. Different groups of patients will participate in each part. PHASE 1 PART 1: Dose Escalation Safety Run-In (CLOSED - Enrollment Completed) During PART 1, all participants will be treated with AdAPT-001 as a single injection, one time. Participants will be assigned to different dose levels to find the highest dose of AdAPT-001 that is safe and tolerable. PHASE 1 PART 2: Dose Expansion Single-Agent (CLOSED - Enrollment…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is capable of understanding the purpose and risks of the study and has provided written Informed Consent. 2. Subject is male or female, aged at least 18 years. 3. Subject has a histologically or cytologically confirmed diagnosis of an advanced malignant solid tumor(s) who have received all conventional therapies considered appropriate by Investigator and have a tumor that is easily accessible and/or palpable for treatment. Ultrasound guidance may be used to aid administration. 4. Subject's Eastern Cooperative Group (ECOG) performance status is 0-1 at Screening.…
Interventions
- BiologicalAdAPT-001
Oncolytic virus administered by intratumoral injection
- DrugCheckpoint Inhibitor, Immune
Checkpoint Inhibitor per investigator discretion based on diagnosis and subject tolerability
Locations (6)
- City of HopeDuarte, California
- California Cancer Associates for Research and Excellence, cCARESan Marcos, California
- Providence Saint John's Health CenterSanta Monica, California
- Cleveland ClinicCleveland, Ohio
- Mary Crowley Cancer ResearchDallas, Texas
- MD Anderson Cancer CenterHouston, Texas