Using AdAPT-001 to treat sarcoma and refractory solid tumors

An Adapted Phase 2a/2b, Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Subjects With Refractory Solid Tumors

This study is testing a new treatment called AdAPT-001 for people with advanced sarcoma and other tough-to-treat solid tumors to see how well it works and what the best dose is.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: EpicentRx, Inc. (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy, prednisone
• Locations: 6 sites (Duarte, California and 5 other locations)
• Trial ID: NCT04673942 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of AdAPT-001, an oncolytic virus administered directly into tumors or through intraarterial injection. The study consists of multiple phases, including dose escalation and expansion, to determine the optimal dosage and efficacy of AdAPT-001, both alone and in combination with checkpoint inhibitors. Participants with advanced solid tumors will be enrolled in a basket trial format to assess the treatment's effectiveness across different tumor types.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced malignant solid tumors that are accessible for treatment and have exhausted standard treatment options.

Not a fit: Patients with early-stage tumors or those who have not yet received conventional therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have not responded to conventional therapies.

How similar studies have performed: Other studies using oncolytic viruses and immunotherapy have shown promise, suggesting potential for success with this approach.

Eligibility criteria

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.
5. Subject has acceptable liver function at Screening, as evidenced by:

   1. Bilirubin \< 1.5 x ULN (upper limit of normal)
   2. AST (SGOT) and ALT (SGPT) \< 3.0 x ULN (upper limit of normal)
   3. Alkaline Phosphatase \< 2.5 x ULN (upper limit of normal)
6. Subject has a Serum Creatinine \< 1.5 x ULN (upper limit of normal)
7. Subject has acceptable hematologic status at Screening, as evidenced by:

   1. Absolute neutrophil count \> 1,500 cells/mm3; \> 1.5 x 109/L, and
   2. Platelet count \> 75,000/mm3; \> 75.0 x 109/L, and
   3. Hemoglobin (HGB) ≥ 8.0 g/dL; ≥ 5.6 mmol/L
8. Subject has an INR \< 1.5
9. Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least one year), and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of AdAPT-001. Medically acceptable contraception is defined as either: 1) usage by at least one of the partners of a barrier method of contraception, together with usage by the female partner, commencing at least three months prior to Study Day 1, of a stable regimen of any form of hormonal contraception or an intra-uterine device, or 2) usage by the couple of a double-barrier method of contraception. Use of a single-barrier method alone or abstinence alone is not considered adequate.
10. Subject is willing and able to comply with all protocol procedures, evaluations and rescue measures.
11. OPTIONAL: Archival formalin-fixed paraffin-embedded block(s) or previously cut archival tissue for at least 5 unstained slides (if available).

Exclusion Criteria:

1. Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
2. A known uncontrolled active bacterial, fungal, or viral infection. No subject with an active SARS-CoV-2 infection (within 14 days of a positive test)
3. Known positive history of human immunodeficiency virus (HIV) test
4. Subjects who have active hepatitis.
5. If female, subject is pregnant and/or breastfeeding.
6. Subjects with active autoimmune disease or history of autoimmune disease that might recur and may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded.

   Note: Subjects in any condition requiring systemic treatment with corticosteroids (prednisone \> 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before AdAPT-001), but currently or previously treated with any of the following steroid regimens were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; prophylactic short-term use of corticosteroids.
7. Prior adenoviral therapy for any indication except vaccination against infectious disease. Subjects receiving COVID-19 or live vaccination, cannot start treatment until 7 days after completing the vaccination. Recommend waiting at least 28 days from AdAPT-001 dose prior to receiving COVID-19 vaccination. Concurrent treatment with Evusheld is allowed.
8. Chemotherapy or immunotherapy within 14 days of study treatment. Hormonal therapy (including tamoxifen, aromatase inhibitors, and gonadotropin releasing hormone agonists) is allowed. Concurrent treatment with bisphosphonate and RANK ligand inhibitor is allowed.

Where this trial is running

Duarte, California and 5 other locations

• City of Hope — Duarte, California, United States (Active_not_recruiting)
• California Cancer Associates for Research and Excellence, cCARE — San Marcos, California, United States (Active_not_recruiting)
• Providence Saint John's Health Center — Santa Monica, California, United States (Active_not_recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• Mary Crowley Cancer Research — Dallas, Texas, United States (Active_not_recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Jeannie Williams

Conditions Solid Tumor, Adult; Cancer; Neoplasms; Sarcoma; Sarcoma,Soft Tissue; Chondrosarcoma; oncolytic virus; immunotherapy