Product Description
Aldoxorubicin is a prodrug of doxorubicin that binds to serum albumin immediately after administration through an acid-sensitive hydrazone linker and is subsequently transported to tumor tissues where the acidic environment cleaves the linker and facilitates delivery of a tumor-targeted drug payload. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5896668/)
Mechanisms of Action: Serum Albumin Binder
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: ImmunityBio
Company Location: SAN DIEGO CA 92121
Company CEO: Richard Adcock
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Sarcoma
Phase 2: Hepatocellular Carcinoma|Chordoma|Pancreatic Cancer|Non-Small-Cell Lung Cancer|Squamous Cell Carcinoma|Small Cell Lung Cancer|Glioblastoma|Adenocarcinoma|Pancreatic Ductal Carcinoma|Sarcoma|Sarcoma, Kaposi|HIV Seropositivity|Triple Negative Breast Cancer
Phase 1: Oncology Solid Tumor Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| QUILT-3.067 | P2 |
Terminated |
Triple Negative Breast Cancer |
2020-09-11 |
45% |
2024-08-10 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date |
| QUILT-3.091 | P2 |
Withdrawn |
Chordoma |
2020-08-31 |
50% |
2021-03-16 |
Primary Endpoints|Treatments |
| TNBC | P2 |
Withdrawn |
Triple Negative Breast Cancer |
2020-06-01 |
50% |
2024-11-27 |
Primary Endpoints|Treatments |
| QUILT-3.088 | P2 |
Withdrawn |
Pancreatic Cancer |
2019-12-30 |
12% |
2021-03-16 |
Primary Endpoints|Treatments |
| QUILT-3.072 | P2 |
Withdrawn |
Hepatocellular Carcinoma |
2019-08-23 |
50% |
2021-03-16 |
Primary Endpoints|Treatments |
| QUILT-3.080 | P2 |
Terminated |
Pancreatic Cancer |
2019-04-17 |
50% |
2024-08-28 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| QUILT-3.090 | P2 |
Terminated |
Squamous Cell Carcinoma |
2019-04-17 |
50% |
2024-08-06 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| QUILT-3.070 | P2 |
Terminated |
Pancreatic Cancer |
2018-09-12 |
50% |
2024-05-23 |
Primary Completion Date|Primary Endpoints |
| QUILT-2.024 | P2 |
Withdrawn |
Non-Small-Cell Lung Cancer |
2018-08-01 |
50% |
2025-02-22 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
| ALDOXORUBICIN-P1/2-STS-03 | P2 |
Completed |
Sarcoma |
2018-05-01 |
2024-05-30 |
Primary Endpoints |
|
| ALDOXORUBICIN-P2-SCLC-01 | P2 |
Completed |
Small Cell Lung Cancer |
2017-05-15 |
2024-11-27 |
Primary Endpoints|Treatments |
|
| 2013-004103-40 | P3 |
Completed |
Sarcoma |
2017-05-15 |
2022-03-13 |
Treatments |
|
| ALDOXORUBICIN-P3-STS-01 | P3 |
Completed |
Sarcoma |
2017-05-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
| ALDOXORUBICIN-P1-MTD-03 | P1 |
Completed |
Oncology Solid Tumor Unspecified |
2017-01-01 |
2024-11-27 |
||
| ALDOXORUBICIN-P2-GBM-01 | P2 |
Completed |
Glioblastoma |
2016-12-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
| ALDOXORUBICIN-P2-KS-01 | P2 |
Completed |
Sarcoma, Kaposi|HIV Seropositivity |
2016-04-25 |
2024-06-12 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
|
| 2014-002189-64 | P2 |
Completed |
Small Cell Lung Cancer |
2016-01-19 |
2025-05-06 |
Treatments |
|
| 2011-004927-11 | P2 |
Completed |
Sarcoma |
2014-12-15 |
2022-03-13 |
Treatments |
|
| ALDOXORUBICIN-P1-PK-01 | P1 |
Completed |
Oncology Solid Tumor Unspecified |
2014-12-01 |
2022-02-12 |
Primary Endpoints|Treatments |
|
| INNO-206-P2-STS-01 | P2 |
Completed |
Sarcoma |
2014-04-09 |
2024-11-27 |
Primary Endpoints|Treatments |
|
| ALDOXORUBICIN-P1-MTD-02 | P1 |
Completed |
Oncology Solid Tumor Unspecified |
2014-04-01 |
2022-02-12 |
Primary Endpoints|Treatments |
|
| INNO-206-P2-PDA-01 | P2 |
Completed |
Adenocarcinoma|Pancreatic Cancer|Pancreatic Ductal Carcinoma |
2013-05-13 |
2024-06-07 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
|
| INNO-206-P1-MTD-01 | P1 |
Completed |
Oncology Solid Tumor Unspecified |
2012-09-01 |
2022-02-12 |
Primary Endpoints|Treatments |
|
| 2006-005514-12 | P2 |
Completed |
Small Cell Lung Cancer |
2008-04-24 |
2022-03-12 |
Treatments |
|
| Aldox Compassionate Use | N/A |
No longer available |
Sarcoma |
None |
2019-03-20 |
Treatments |