A Study of AdAPT-001 for Sarcoma and Other Solid Tumors
This study is testing a treatment called AdAPT-001, which is an oncolytic virus (a virus that infects and kills cancer cells). It's given by injecting it directly into the tumor. Researchers want to see if AdAPT-001 is safe and tolerable, sometimes given along with a checkpoint inhibitor (a type of drug that helps your immune system fight cancer). This study is for adults aged 18 and older with advanced solid tumors, including sarcoma, who have already tried other standard treatments. The main goals are to find a safe dose and understand any side effects. Enrollment for all parts of this study is currently closed.
- Study design
- This is an interventional study with 140 planned participants. It has three parts, all of which are now closed to enrollment.
- What's involved
- In Part 1, participants received a single injection of AdAPT-001. In Part 2 and Arm 1 of Part 3, participants received injections of AdAPT-001 on specific days over 28-day cycles. Arm 2 of Part 3 involved AdAPT-001 with a checkpoint inhibitor.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured for up to 6 months after treatment.
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A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors
At a glance
Conditions
Where it's being run
6 sites across 3 statesStudy leadership
- Bryan Oronsky, MD PhD · STUDY_DIRECTOR · EpicentRx, Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Dose Limiting Toxicities (DLT)28 days
All subjects in PART 1 will be assessed for the development of dose-limiting toxicity (DLT) during treatment with AdAPT-001. The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up). A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
- Maximum tolerated dose28 days
In PART 1, A MTD is determined if any cohort experiences 2 subjects with DLT's.
- Safety of a multiple dose regimen of AdAPT-0016 months
The safety data will include adverse events, serious adverse events, performance status, clinical laboratory tests, vital signs and physical examination results.
- Anti-tumor activity of the two-arm dose regimens of AdAPT-001 in Phase 26 months
To evaluate the efficacy of the two-arm dose regimens of AdAPT-001 in subjects with advanced solid tumors that have progressed after treatment with standard therapies or for which there are no appropriate therapies available as measured by durable (≥4 months) stable disease per Response Evaluation Criteria in Solid Tumors (RECIST).