AdAPT-001 for Cancer
(BETA-PRIME Trial)
Recruiting at 5 trial locations
JW
Overseen ByJeannie Williams
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: EpicentRx, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have chemotherapy or immunotherapy within 14 days of starting the study treatment. Hormonal therapies and certain other treatments are allowed.
Research Team
BO
Bryan Oronsky, MD PhD
Principal Investigator
EpicentRx, Inc.
Eligibility Criteria
Adults with advanced solid tumors that have failed conventional treatments can join this trial. They must have good liver, kidney, and blood health, not be pregnant or breastfeeding, use contraception if of childbearing potential, and understand the study's risks. Excluded are those with HIV, active hepatitis or autoimmune diseases requiring steroids, recent chemotherapy or immunotherapy (within 14 days), uncontrolled infections including COVID-19 within 14 days.Inclusion Criteria
Subject has an INR < 1.5
I have an advanced cancer that has been confirmed by tests, and it's accessible for treatment.
AST (SGOT) and ALT (SGPT) < 3.0 x ULN (upper limit of normal)
See 13 more
Exclusion Criteria
You have a serious medical condition or an untreated health problem that could interfere with the study.
I have not had adenoviral therapy except for vaccines, and it's been 7 days since my last vaccine.
I haven't had chemotherapy or immunotherapy in the last 14 days, but I may be on hormonal therapy or treatments for bone health.
See 6 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation Safety Run-In
Participants receive a single injection of AdAPT-001 to determine the highest safe and tolerable dose
28 days
1 visit (in-person)
Dose Expansion Single-Agent
Participants receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles
6 months
12 visits (in-person)
Expansion
Participants receive AdAPT-001 with or without a checkpoint inhibitor on Days 1 and 15 of 28-day cycles
6 months
12 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- AdAPT-001
Trial Overview The trial is testing AdAPT-001—an oncolytic virus injected into tumors—to determine its highest safe dose for future cancer treatment. It's a first-in-human study to see if it could help treat various cancers by injecting directly into the tumor sites.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Phase 2 (Enrollment Open)Experimental Treatment2 Interventions
Approximately 55 to 80 subjects with advanced solid tumors including sarcoma to receive either AdAPT-001 on Days 1 and 15 of 28-day cycles or AdAPT-001 on Days 1 and 15 plus a checkpoint inhibitor of 28-day cycles..
Group II: PART 3: Expansion (Enrollment Completed)Experimental Treatment2 Interventions
Up to 45 subjects will be enrolled in the expansion cohort to receive either AdAPT-001 on Days 1 and 15 of 28-day cycles or AdAPT-001 on Days 1 and 15 plus a checkpoint inhibitor of 28-day cycles.
Group III: PART 2: Dose Expansion Single-Agent (Enrollment Completed)Experimental Treatment1 Intervention
6 subjects will be enrolled in the Lead In Cohort. A Safety Analysis will be performed after 6 subjects have received at least 24 doses. Upon Safety team review as a continuous reassessment of safety, an additional 19 subjects may be enrolled. All subjects in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles.
Group IV: PART 1: Dose Escalation Safety Run-In (Enrollment Completed)Experimental Treatment1 Intervention
Subjects will be treated with AdAPT-001 as a single injection, one time.
AdAPT-001 is already approved in United States for the following indications:
Approved in United States as AdAPT-001 for:
- Recurrent or refractory advanced or metastatic soft tissue sarcoma (STS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
EpicentRx, Inc.
Lead Sponsor
Trials
16
Recruited
1,000+
Findings from Research
A new screening method using phage display successfully identified specific peptides recognized by antibodies from prostate cancer patients, highlighting a consensus motif linked to cancer progression.
The presence of antibodies against this peptide motif was associated with shorter survival rates and the development of metastatic disease, suggesting its potential as a molecular marker for targeted therapies.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Fingerprinting the circulating repertoire of antibodies from cancer patients.Mintz, PJ., Kim, J., Do, KA., et al.[2023]
Research has shown that tumor antigens can trigger immune responses in cancer patients, but these responses often fail to stop tumor progression, highlighting the need for enhanced immunization strategies.
Early clinical trials of cancer vaccines have shown some clinical benefits, but challenges remain in identifying effective antigens, defining the immune responses needed, and selecting suitable delivery systems for the vaccines.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Cancer vaccines and immunotherapies: emerging perspectives.Henderson, RA., Mossman, S., Nairn, N., et al.[2005]
Disease-related antigens are crucial in clinical settings for cancer screening, monitoring therapy responses, and serving as therapeutic targets, highlighting their importance in cancer management.
Protein microarrays have been effectively utilized to identify these antigens across various diseases, including cancer, by comparing immune responses from patient samples to those of healthy controls.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Serum profiling using protein microarrays to identify disease related antigens.Sharon, D., Snyder, M.[2021]
References
Fingerprinting the circulating repertoire of antibodies from cancer patients. [2023]
Cancer vaccines and immunotherapies: emerging perspectives. [2005]
Serum profiling using protein microarrays to identify disease related antigens. [2021]
Preclinical strategies to define predictive biomarkers for therapeutically relevant cancer subtypes. [2021]
Feasibility and first reports of the MATCH-R repeated biopsy trial at Gustave Roussy. [2022]
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