AdAPT-001 for Cancer

Mary Crowley Cancer Research, Dallas, TX
Cancer+2 More ConditionsAdAPT-001 - Biological
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new cancer treatment, AdAPT-001, which is an injected virus that kills cancer cells. The purpose is to find the highest dose that is safe and tolerable. If successful, this could be used to treat others with cancer in the future.

Eligible Conditions
  • Solid Tumors, Adult
  • Cancer
  • Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Study Objectives

3 Primary · 1 Secondary · Reporting Duration: 6 months

28 days
Dose Limiting Toxicities (DLT)
Maximum tolerated dose
6 months
Anti-tumor activity by iRECIST
Anti-tumor activity of AdAPT-001
Biodistribution
Safety of a multiple dose regimen of AdAPT-001

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

5 Treatment Groups

Part 2: Dose Expansion Single-Agent
1 of 5
Part 1: Dose Escalation Safety Run-In
1 of 5
PART 1: Dose Escalation Safety Run-In
1 of 5
PART 2: Dose Expansion Single-Agent
1 of 5
PART 3: Expansion
1 of 5

Experimental Treatment

79 Total Participants · 5 Treatment Groups

Primary Treatment: AdAPT-001 · No Placebo Group · Phase 1 & 2

Part 2: Dose Expansion Single-Agent
Biological
Experimental Group · 1 Intervention: AdAPT-001 · Intervention Types: Biological
Part 1: Dose Escalation Safety Run-In
Biological
Experimental Group · 1 Intervention: AdAPT-001 · Intervention Types: Biological
PART 1: Dose Escalation Safety Run-In
Biological
Experimental Group · 1 Intervention: AdAPT-001 · Intervention Types: Biological
PART 2: Dose Expansion Single-Agent
Biological
Experimental Group · 1 Intervention: AdAPT-001 · Intervention Types: Biological
PART 3: ExpansionExperimental Group · 2 Interventions: AdAPT-001, Checkpoint Inhibitor, Immune · Intervention Types: Biological, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

EpicentRx, Inc.Lead Sponsor
14 Previous Clinical Trials
698 Total Patients Enrolled
Bryan Oronsky, MD PhDStudy DirectorEpicentRx, Inc.

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

How many participants are involved in this medical research?

"Affirmative, the data hosted on clinicaltrials.gov attests that this medical trial is actively recruiting participants. The investigation was first posted back in March 29th 2021 and has been revised as recently as August 31st 2022. 40 individuals are needed for 6 different sites to take part in this study." - Anonymous Online Contributor

Unverified Answer

How many medical centers are taking part in the experiment?

"Six medical centres are involved in the running of this trial, including Mary Crowley Cancer Research (Dallas), Cleveland Clinic (Cleveland) and MD Anderson Cancer Center (Houston). There are also three additional facilities." - Anonymous Online Contributor

Unverified Answer

Has the AdAPT-001 drug been sanctioned by the FDA?

"Due to limited data regarding its safety and efficacy, AdAPT-001 was assigned a score of 1 on the risk scale." - Anonymous Online Contributor

Unverified Answer

Are there any open slots in this clinical trial at the present time?

"Affirmative. Clinicaltrials.gov contains evidence that this medical trial, initially announced on March 29th 2021, is actively recruiting patients. In total, 40 individuals are required to be recruited from 6 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.