A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors (BETA-PRIME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04673942|
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : September 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult Cancer Neoplasms||Biological: AdAPT-001||Phase 1|
This is a dose escalation protocol to determine, first and foremost, the safety, tolerability and feasibility of intratumoral administration of AdAPT-001.
The study has 2 parts. Different groups of patients will participate in each part.
PART 1: Dose Escalation Safety Run-In
During part 1, all participants will be treated with AdAPT-001 as a single injection, one time. Participants will be assigned to different dose levels to find the highest dose of AdAPT-001 that is safe and tolerable.
PART 2: Dose Expansion Single-Agent
All participants in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles. The dose of AdAPT-001 used in Part 2 will be decided by the results from Part 1.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||The study is an exploratory open label single-arm interventional study using a 3 + 3 dose escalation safety run-in (Part 1) followed by a dose expansion single-agent (Part 2).|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, First in Human, Study to Evaluate the Safety and Tolerability of AdAPT-001 in Subjects With Refractory Solid Tumors|
|Actual Study Start Date :||March 29, 2021|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||June 1, 2023|
Experimental: Part 1: Dose Escalation Safety Run-In
Subjects will be treated with AdAPT-001 as a single injection, one time.
Oncolytic virus administered by intratumoral injection
Experimental: Part 2: Dose Expansion Single-Agent
6 subjects will be enrolled in the Lead In Cohort. A Safety Analysis will be performed after 6 subjects have received at least 4 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.
Oncolytic virus administered by intratumoral injection
- Dose Limiting Toxicities (DLT) [ Time Frame: 28 days ]All subjects in part 1 will be assessed for the development of dose-limiting toxicity (DLT) during treatment with AdAPT-001. The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up). A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
- Maximum tolerated dose [ Time Frame: 28 days ]In part 1, A MTD is determined if any cohort experiences 2 subjects with DLT's.
- Safety of a multiple dose regimen of AdAPT-001 [ Time Frame: 6 months ]The safety data will include adverse events, serious adverse events, performance status, clinical laboratory tests, vital signs and physical examination results.
- Anti-tumor activity of AdAPT-001 [ Time Frame: 6 months ]In part 2, overall response rate (ORR) and best overall response rates per response evaluation criteria outlined in Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), as well as progression-free survival (PFS), and duration of response will be assessed.
- Anti-tumor activity by iRECIST [ Time Frame: 6 months ]ORR and best overall response rates per Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
- Biodistribution [ Time Frame: 6 months ]This outcome will measure TGFβ trap concentrations in the serum and, in patients who consent to tissue collections, test for TGFβ trap expression in the treated tumors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673942
|Contact: Jeannie Williamsfirstname.lastname@example.org|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Victoria Villaflor, MD 877-467-3411|
|Principal Investigator: Victoria Villaflor, MD|
|California Cancer Associates for Research and Excellence, cCARE||Recruiting|
|San Marcos, California, United States, 92069|
|Contact: Alberto Bessudo, MD 760-747-8935|
|Principal Investigator: Alberto Bessudo, MD|
|Providence Saint John's Health Center||Recruiting|
|Santa Monica, California, United States, 90404|
|Contact: Naveed Wagle, MD 310-582-7448 email@example.com|
|Principal Investigator: Naveed Wagle, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Sarah Kabalan 866-223-8100|
|Principal Investigator: Brian Gastman, MD|
|United States, Texas|
|Mary Crowley Cancer Research||Recruiting|
|Dallas, Texas, United States, 75230|
|Contact: Minal Barve, MD 972-566-3000 firstname.lastname@example.org|
|Principal Investigator: Minal Barve, MD|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Anthony P Conley, MD|
|Principal Investigator: Anthony P Conley, MD|
|Study Director:||Bryan Oronsky, MD PhD||EpicentRx, Inc.|