Cancer Clinical Trial
Official title:
An Adapted Phase 2a/2b, Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Subjects With Refractory Solid Tumors
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.
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 3 parts. Different groups of patients will participate in each part. PHASE 1 PART 1: Dose Escalation Safety Run-In (CLOSED - Enrollment Completed) 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. PHASE 1 PART 2: Dose Expansion Single-Agent (CLOSED - Enrollment Completed) All participants in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles. PHASE 1 PART 3: Expansion (CLOSED - Enrollment Completed) Subjects will be assigned to the following two arms. If a checkpoint inhibitor is indicated for the subject, the subject may be enrolled on Arm 2 per investigator discretion, otherwise subjects may be enrolled on Arm 1. Arm 1: Intratumoral administration of AdAPT-001 (1.0 x 10¹² viral particles) on Day 1 and 15 of each 28-day cycle for up to 12 injections. Arm 2: Intratumoral administration of AdAPT-001 (1.0 x 10¹² viral particles) on Day 1 and 15 of each 28-day cycle for up to 12 injections plus a checkpoint inhibitor per investigator discretion PHASE 2: (OPEN to Enrollment) Subjects with advanced solid tumors will participate in a basket two-arm parallel group evaluation (Phase 2) where eligible participants will be assigned to the following two arms based on confirmed histology by the treating investigator. Arm 1: Confirmed Histological Diagnosis of Sarcoma Intratumoral Administration of AdAPT-001 (1.0 x 10¹² viral particles) on Day 1 and 15 of each 28-day cycle for up to 12 injections with or without a checkpoint inhibitor. Arm 2: Confirmed Histological Diagnosis of Advanced Solid Tumor indicated to receive at least one checkpoint inhibitor. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
| Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
| Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
| Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
| Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
| Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
| Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
| Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
| Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
| Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
| Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|