Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Dose Escalation Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Biological Properties of Recombinant Human IL-21 Oncolytic Vaccinia Virus Injection (hV01) in Patients With Advanced Malignant Solid Tumors
The goal of this clinical trial is to evaluate the safety, tolerance, pharmacokinetics, and biological properties of recombinant human IL-21 oncolytic vaccinia virus injection (hV01) in patients with advanced solid tumors.
This is a multi-site, single-arm, open-label, dose-escalation study. It consists of two phases: Part A involves a single-dose escalation, and Part B evaluates the safety and tolerability of multiple doses of hV01. Part A: Dose escalation with four dose levels from 1.0×10^7 PFU to 8.0×10^8 PFU. The standard 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD). The participants will be observed for dose-limiting toxicities (DLTs) for 28 days after the single dose of the first cycle. Part B: After completion of Part A, the sub-MTD/MAD will be chosen for Part B, which will evaluate the safety and tolerability of hV01 administration at two different frequencies: twice per cycle (on days 1 and 8) and three times per cycle (on days 1, 8, and 15). The standard 3+3 design will also be used for this phase. The first cohort, receiving two doses per cycle, will be observed for DLTs for 35 days after the first dose, while the second cohort, receiving three doses per cycle, will be observed for DLTs for 42 days after the first dose. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04972981 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT05086822 -
A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03260322 -
A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT06040541 -
Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05862831 -
Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03641794 -
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT03665129 -
IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06413680 -
A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05914116 -
A Study of DB-1311 in Advanced/Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01693562 -
A Phase 1/2 Study to Evaluate MEDI4736
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04387916 -
A Study of KC1036 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT04095273 -
Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug
|
Phase 1 | |
| Not yet recruiting |
NCT03692520 -
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02997176 -
An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
|
Phase 1 | |
| Recruiting |
NCT04446260 -
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT02253992 -
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06076291 -
An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03545971 -
A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.
|
Phase 1 |