12 completed, 5 terminated, 3 recruiting, 1 withdrawn. 12 Phase 1, 10 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 12 | Completed 6, Recruiting 3, Terminated 3 |
| Phase 2 | 10 | Completed 8, Terminated 1, Withdrawn 1 |
| Phase 3 | 1 | Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK) Nivolumab, HC-7366, ipilimumab - Phase 1b, HC-7366 | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 35 | 2026-03-24 | 2026-09-25 |
| Phase I Study of HC-7366 for Acute Myeloid Leukemia HC-7366 - Acute Myeloid Leukemia | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 18 | 2024-05-20 | 2026-08-10 |
| A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma HC-7366, Belzutifan - Renal Cell Carcinoma | Phase 1 | Recruiting | HiberCell, Inc. | 80 | 2024-04-29 | 2026-10-02 |
| A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma odetiglucan, CDX-1140 - Metastatic Pancreatic Adenocarcinoma | Phase 1 | Terminated | HiberCell, Inc. | 5 | 2022-12-15 | 2024-04-10 |
| A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) HC-7366 - Squamous Cell Carcinoma of Head and Neck, Colo-rectal Cancer | Phase 1 | Terminated | HiberCell, Inc. | 35 | 2022-02-23 | 2024-03-08 |
| Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA) Imprime PGG, Pembrolizumab - Malignant Neoplasm of Breast | Phase 2 | Completed | HiberCell, Inc. | 26 | 2021-11-09 | 2023-06-22 |
| Study of Neoadjuvant Imprime PGG and Pembrolizumab for Stage III, Resectable Melanoma Imprime PGG, Pembrolizumab - Pathologic Stage III Cutaneous Melanoma AJCC v8 | Phase 2 | Withdrawn | HiberCell, Inc. | 2021-08-15 | 2021-11-05 | |
| A Study of HC-5404-FU to Establish the Maximum Tolerated Dose (MTD) HC-5404-FU - Renal Cell Carcinoma, Gastric Cancer | Phase 1 | Completed | HiberCell, Inc. | 23 | 2021-06-08 | 2024-03-08 |
| Phase 2 Study of Imprime PGG & Pembrolizumab in Subjects With Adv SCCHN Who Failed Pembro Monotherapy or Experiencing SD Imprime PGG, Pembrolizumab - Squamous Cell Carcinoma of the Head and Neck | Phase 2 | Terminated | HiberCell, Inc. | 1 | 2017-11-08 | 2018-12-14 |
| Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017 Imprime PGG, MK-3475 - Non-Small Cell Lung Cancer | Phase 1 / Phase 2 | Completed | Lawrence Feldman, MD | 35 | 2017-07-11 | 2026-01-20 |
| Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer Imprime PGG, Pembrolizumab - Advanced Melanoma, Triple-Negative Breast Cancer | Phase 2 | Completed | HiberCell, Inc. | 64 | 2017-02-22 | 2024-07-09 |
| A Phase 2 Clinical Trial of Rituxan and B-Glucan PGG in Relapsed Indolent Non-Hodgkin Lymphoma Imprime PGG, Rituximab - Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphomas | Phase 2 | Completed | Dana-Farber Cancer Institute | 25 | 2014-12-01 | 2026-04-06 |
| (PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer BTH1704, IMPRIME PGG, Gemcitabine - Pancreatic Cancer | Phase 1 | Terminated | University of Illinois at Chicago | 3 | 2014-08-01 | 2015-05-01 |
| Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer Imprime PGG + cetuximab, Cetuximab - Colorectal Cancer | Phase 3 | Terminated | HiberCell, Inc. | 217 | 2011-04-01 | 2017-07-13 |
| Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer Imprime PGG Injection, Cetuximab, Paclitaxel - NSCLC | Phase 2 | Completed | HiberCell, Inc. | 90 | 2009-08-01 | 2016-11-29 |
| Efficacy and Safety Study of Imprime PGG With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer Imprime PGG - Colorectal Cancer | Completed | HiberCell, Inc. | 18 | 2009-06-01 | 2012-02-15 | |
| Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC) Imprime PGG® Injection, Bevacizumab, Paclitaxel - Non-Small Cell Lung Cancer | Phase 2 | Completed | HiberCell, Inc. | 90 | 2009-06-01 | 2017-03-03 |
| Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma Imprime PGG 2 mg/kg, Imprime PGG 4 mg/kg, Cetuximab - Recurrent Colorectal Carcinoma, Progressive Colorectal Carcinoma | Phase 1 / Phase 2 | Completed | HiberCell, Inc. | 32 | 2007-10-01 | 2025-03-19 |
| Phase I/II, Randomized, Double-Blind, Study of the Progenitor Cell Mobilizing Effects of Imprime PGG™ Injection Administered at Varied Dosing Regimens With G-CSF Versus G-CSF Alone Imprime PGG TM for Injection - Healthy | Phase 1 / Phase 2 | Completed | HiberCell, Inc. | 66 | 2006-11-01 | 2007-10-11 |
| Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Imprime PGG™ Injection Imprime PGG TM for Injection - Healthy | Phase 1 | Completed | HiberCell, Inc. | 12 | 2006-05-01 | 2007-10-11 |
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Recurrence (4) · Carcinoma, Non-Small-Cell Lung (3) · Carcinoma, Renal Cell (3) · Colorectal Neoplasms (3) · Breast Neoplasms (2) · Kidney Neoplasms (2) · Neoplasm Metastasis (2) · Squamous Cell Carcinoma of Head and Neck (2) · Anophthalmia with pulmonary hypoplasia (1) · Carcinoma (1) · Colonic Neoplasms (1) · Leukemia, Myeloid, Acute (1) · Melanoma (1) · Pancreatic Neoplasms (1) · Small Cell Lung Carcinoma (1)
pembrolizumab (5) · Cetuximab (4) · BTH1677 (3) · Carboplatin (2) · Injections (2) · Paclitaxel (2) · Albumin-Bound Paclitaxel (1) · Bevacizumab (1) · Gemcitabine (1) · Ipilimumab (1) · Irinotecan (1) · Nivolumab (1) · Rituximab (1) · belzutifan (1) · epitumomab (1)
United States (17) · Germany (3) · France (1) · Philippines (1) · Puerto Rico (1)
Folker Schneller, MD (2) · Jose Iglesias, MD (2) · Abhishek Maiti, MD (1) · Alison Stopeck, MD (1) · Caron Jacobson, MD (1) · Eric Jonasch, MD (1) · Gerardo Cornelio, MD, FPCP/FPS (1) · Jeremy D Graff, PhD (1) · Lawrence Feldman, M.D. (1) · Leonard Saltz, MD (1) · Ma. Belen Tamayo, MD (1) · Mark O'Hara (1) · Neeta Venepalli, MD (1) · Neil H. Segal, MD, PhD (1) · Neil Senzer, MD (1)