CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 140 target
Drug / intervention
AdAPT-001 +1 morebiological
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Histologically or cytologically confirmed advanced malignant solid tumor(s)
  • ✓Received all conventional therapies considered appropriate
  • ✓Tumor easily accessible and/or palpable for treatment
  • ✓Age at least 18 years
Key exclusion· 9
  • ✕Serious co-morbid medical condition or clinically significant laboratory finding suggesting inadequately treated systemic disorder
  • ✕Uncontrolled active bacterial, fungal, or viral infection
  • ✕Active SARS-CoV-2 infection within 14 days of positive test
  • ✕Known positive HIV test

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04673942
NCT04673942Phase 2ActiveOn Track
CompareCT.gov

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

EpicentRx, Inc.·interventional·Posted Dec 17, 2020·Updated Jun 26, 2026

In Brief

A Phase 2 clinical trial evaluating AdAPT-001 and Checkpoint Inhibitor, Immune for Solid Tumor, Adult and 5 related conditions. Active but no longer recruiting, targeting 140 participants across 6 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Adult, Cancer, Neoplasms, Sarcoma, Sarcoma,Soft Tissue, Chondrosarcoma
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
2021202220232024202520262027
First PostedDec 17, 2020
Enrollment StartMar 29, 2021
Primary CompletionDec 1, 2026
Study CompletionMar 1, 2027
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 5.5 years agoPrimary completion in 5 months

Arms & Interventions

PART 1: Dose Escalation Safety Run-In (Enrollment Completed)experimental

Subjects will be treated with AdAPT-001 as a single injection, one time.

Biological: AdAPT-001
PART 2: Dose Expansion Single-Agent (Enrollment Completed)experimental

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.

Biological: AdAPT-001
PART 3: Expansion (Enrollment Completed)experimental

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.

Biological: AdAPT-001Drug: Checkpoint Inhibitor, Immune
Phase 2 (Enrollment Open)experimental

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..

Biological: AdAPT-001Drug: Checkpoint Inhibitor, Immune

Interventions

AdAPT-001biological

Oncolytic virus administered by intratumoral injection

Checkpoint Inhibitor, Immunedrug

Checkpoint Inhibitor per investigator discretion based on diagnosis and subject tolerability