7 completed, 1 active not recruiting, 1 terminated, 1 withdrawn. 8 Early Phase 1, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Early Phase 1 | 8 | Completed 5, Active not recruiting 1, Terminated 1, Withdrawn 1 |
| Phase 1 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC Rilvegostomig, Volrustomig, Sabestomig - Head and Neck Squamous Cell Carcinoma | Early Phase 1 | Completed | Presage Biosciences | 17 | 2024-05-22 | 2026-06-26 |
| A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors PBA-0405 - Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult | Early Phase 1 | Completed | Pure Biologics S.A. | 8 | 2024-04-29 | 2025-08-11 |
| PBI-MST-01 (NCT04541108) Substudy MSD-03: Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in HNSCC or STS Pembrolizumab, MK-0482 + Pembrolizumab, MK-4830 + Pembrolizumab - Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma | Early Phase 1 | Completed | Presage Biosciences | 13 | 2022-06-01 | 2024-05-14 |
| Intratumoral Microdosing of Motolimod in HNSCC Motolimod, Nivolumab, Motolimod + Nivolumab - HNSCC | Early Phase 1 | Terminated | Presage Biosciences | 1 | 2021-10-15 | 2022-04-14 |
| CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia MVC-101, Nivolumab, MVC-101 + Nivolumab - Solid Tumour | Early Phase 1 | Withdrawn | Presage Biosciences | 2021-09-15 | 2022-07-08 | |
| PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC TAK-676, Carboplatin, 5-FU - Head and Neck Squamous Cell Carcinoma | Early Phase 1 | Completed | Presage Biosciences | 15 | 2021-07-26 | 2023-10-06 |
| Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies Rilvegostomig, Volrustomig, Sabestomig - Solid Tumor | Early Phase 1 | Active not recruiting | Presage Biosciences | 15 | 2021-07-26 | 2026-05-22 |
| Intratumoral Microdosing of TAK-981 in Head and Neck Cancer TAK-981, Cetuximab, Avelumab - Head and Neck Cancer | Early Phase 1 | Completed | Presage Biosciences | 12 | 2020-10-07 | 2022-07-29 |
| Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma Multiple drug microinjection, CIVO device - Soft Tissue Sarcoma Adult | Phase 1 | Completed | Presage Biosciences | 23 | 2016-12-15 | 2021-09-24 |
| Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them - Lymphoma | Phase 1 | Completed | Presage Biosciences | 4 | 2012-11-01 | 2017-02-27 |
Squamous Cell Carcinoma of Head and Neck (8) · Head and Neck Neoplasms (7) · Sarcoma (4) · Lymphoma (3) · Melanoma (2) · Triple Negative Breast Neoplasms (1)
pembrolizumab (4) · Nivolumab (3) · Doxorubicin (2) · avelumab (2) · Bendamustine Hydrochloride (1) · Bortezomib (1) · CP protocol (1) · Carboplatin (1) · Cetuximab (1) · Docetaxel (1) · Fluorouracil (1) · Gemcitabine (1) · Interferon alpha-2 (1) · Interferon-gamma (1) · Ipilimumab (1)
United States (9) · Australia (1)
Gary Deutsch, MD (1) · John Weinberg (1) · Kenneth Gundle, MD (1) · Oliver W Press, MD, PhD (1) · Seth Pollack, MD (1) · Wendy Jenkins (1)
PMID 32299817, PMID 36923556, PMID 40373381
R42CA144104 (1)