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

Part of paid clinical trials in Duarte, California.

Sponsor
EpicentRx, Inc.
Study ID
NCT04673942
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AdAPT-001 — BIOLOGICAL
    Oncolytic virus administered by intratumoral injection
  • Checkpoint Inhibitor, Immune — DRUG
    Checkpoint Inhibitor per investigator discretion based on diagnosis and subject tolerability

Study Details

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.

Key Dates

Start date
Mar 29, 2021
Status verified
Oct 2024
Primary completion
Dec 1, 2025
Completion
Mar 1, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PART 1: Dose Escalation Safety Run-In (Enrollment Completed)
    Subjects will be treated with AdAPT-001 as a single injection, one time.
  • Experimental: PART 2: Dose Expansion Single-Agent (Enrollment Completed)
    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.
  • Experimental: PART 3: Expansion (Enrollment Completed)
    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.
  • Experimental: Phase 2 (Enrollment Open)
    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..

Primary Outcome Measure

Dose Limiting Toxicities (DLT) [ Time Frame: 28 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
California Cancer Associates for Research and Excellence, cCARESan MarcosCalifornia92069-
Providence Saint John's Health CenterSanta MonicaCalifornia90404-
Cleveland ClinicClevelandOhio44195
Cancer Answer
216-444-7923
Brielle Eble
Lucy Boyce Kennedy, MD (PRINCIPAL_INVESTIGATOR)
Mary Crowley Cancer ResearchDallasTexas75230-
MD Anderson Cancer CenterHoustonTexas77030
Anthony P Conley, MD
Anthony P Conley, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CACalifornia Cancer Associates for Research and Excellence, cCARE· San Marcos, CAProvidence Saint John's Health Center· Santa Monica, CACleveland Clinic· Cleveland, OHMary Crowley Cancer Research· Dallas, TXMD Anderson Cancer Center· Houston, TX

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