RECRUITING

A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors

Conditions

Solid Tumor, Adult Cancer Neoplasms Sarcoma Sarcoma,Soft Tissue Chondrosarcoma oncolytic virus immunotherapy adenovirus intratumoral injection AdAPT-001

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-29

Study Completion:2027-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04673942

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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. 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.

Inclusion Criteria

Exclusion 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).

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.
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.

Contacts and Locations

Study Contact

Jeannie Williams

CONTACT

858-947-6644

info@epicentrx.com

Principal Investigator

Bryan Oronsky, MD PhD

STUDY_DIRECTOR

EpicentRx, Inc.

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

California Cancer Associates for Research and Excellence, cCARE

San Marcos, California, 92069

United States

Providence Saint John's Health Center

Santa Monica, California, 90404

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: EpicentRx, Inc.

Bryan Oronsky, MD PhD, STUDY_DIRECTOR, EpicentRx, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-29

Study Completion Date2027-03-01

Study Record Updates

Study Start Date2021-03-29

Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

oncolytic virus
immunotherapy
adenovirus
intratumoral injection
AdAPT-001
Sarcoma

Additional Relevant MeSH Terms

Solid Tumor, Adult
Cancer
Neoplasms
Sarcoma
Sarcoma,Soft Tissue
Chondrosarcoma