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.
- Solid Tumors, Adult
3 Primary · 1 Secondary · Reporting Duration: 6 months
Awards & Highlights
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
79 Total Participants · 5 Treatment Groups
Primary Treatment: AdAPT-001 · No Placebo Group · Phase 1 & 2
Who is running the clinical trial?
Age 18+ · All Participants · 0 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Kesari, Santosh, Alberto Bessudo, Brian R Gastman, Anthony P Conley, Victoria M Villaflor, Lisle M Nabell, DeLisa Madere, et al.. 2022. “BETA PRIME: Phase I Study of Adapt-001 as Monotherapy and Combined with a Checkpoint Inhibitor in Superficially Accessible, Treatment-refractory Solid Tumors”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2022-0481.
- Kesari S, Bessudo A, Gastman BR, Conley AP, Villaflor VM, Nabell LM, Madere D, Chacon E, Spencer C, Li L, Larson C, Reid T, Caroen S, Oronsky B, Stirn M, Williams J, Barve MA. BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors. Future Oncol. 2022 Sep;18(29):3245-3254. doi: 10.2217/fon-2022-0481. Epub 2022 Aug 11. Review.
- Kesari S, Bessudo A, Gastman BR, Conley AP, Villaflor VM, Nabell LM, Madere D, Chacon E, Spencer C, Li L, Larson C, Reid T, Caroen S, Oronsky B, Stirn M, Williams J, Barve MA. BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors. Future Oncol. 2022 Sep;18(29):3245-3254. doi: 10.2217/fon-2022-0481. Epub 2022 Aug 11.
- 2021. "A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04673942.
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
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
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
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