A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
NCT06273852 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-08-11
Summary
This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device.
Conditions
- Head and Neck Squamous Cell Carcinoma
- Soft Tissue Sarcoma Adult
- Triple Negative Breast Cancer
Interventions
- DRUG
-
PBA-0405
Intratumoral microdose injection by the CIVO device.
Sponsors & Collaborators
-
Presage Biosciences
collaborator INDUSTRY -
Pure Biologics S.A.
lead INDUSTRY
Principal Investigators
-
John Weinberg · Pure Biologics
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-29
- Primary Completion
- 2025-03-15
- Completion
- 2025-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Phase I Study of PM02734 in Subjects With Advanced Malignant Solid Tumors
NCT00404521 ·Status: TERMINATED ·Phase: PHASE1
-
A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies
NCT02013804 ·Status: COMPLETED ·Phase: PHASE1
-
Pazopanib Hydrochloride in Treating Patients With Advanced or Refractory Solid Tumors
NCT01552356 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study of PM060184 in Patients With Advanced Solid Tumors
NCT01299636 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors
NCT06293651 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors
NCT05901285 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of PY314 in Subjects With Advanced Solid Tumors
NCT04691375 ·Status: TERMINATED ·Phase: PHASE1
-
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
NCT02009449 ·Status: COMPLETED ·Phase: PHASE1
-
GW786034 in Treating Patients With Advanced Solid Tumors
NCT00060151 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
NCT01447225 ·Status: COMPLETED ·Phase: PHASE1
-
Study of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks
NCT01405391 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent
NCT06075849 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors
NCT06285097 ·Status: TERMINATED ·Phase: PHASE1
-
Part A: Radiolabel Study With GW786034 Part B: Single Dose of GW786034
NCT00478725 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors
NCT04344795 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Solid Tumors
NCT00104286 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia
NCT04891718 ·Status: WITHDRAWN ·Phase: EARLY_PHASE1
-
Phase I Ascending Multiple-Dose Study of BMS-986115 in Subjects With Advanced Solid Tumors
NCT01986218 ·Status: TERMINATED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients
NCT01337765 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors
NCT00879554 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
NCT06131398 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
NCT05142592 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
NCT05410145 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors
NCT01957735 ·Status: COMPLETED ·Phase: PHASE1
-
Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
NCT01654965 ·Status: COMPLETED ·Phase: PHASE1