Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
m2 aldoxorubicin, m2 aldoxorubicin · 2 trials · 2 indications
ORR was defined as the proportion of patients with objective CR or PR by RANO working group criteria. CR: required all the following: complete disappearance of all enhancing measurable/ non-measurable disease sustained for at least 4 weeks; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions; patients must be off corticosteroids (or on physiologic replacement doses only); and stable or improved clinically. Patients with non-measurable disease only cannot have a CR. PR: Requires all of the following: ≥50% decrease compared with baseline sustained for at least 4 weeks; no PD of non-measurable disease; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at the time of the baseline scan; and stable or improved clinically. Patients with non-measurable disease only can't have a PR.
The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in subjects with metastatic, locally advanced, or unresectable soft tissue sarcoma as measured by the frequency and severity of adverse events (AEs). The following assessments were used to determine if subjects had adverse events: * vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area) * physical examination * laboratory tests (chemistry, hematology, urinalysis, anion gap) additionally, the following scans were performed to determine adverse events: * ECHO / MUGA * ECG
| Arm | Type | Description |
|---|---|---|
| 250 mg/m2 aldoxorubicin | EXPERIMENTAL | Subjects received 250 mg/m2 aldoxorubicin IV. |
| 350 mg/m2 aldoxorubicin | EXPERIMENTAL | Subjects received 350 mg/m2 aldoxorubicin IV. |
| 170 mg/m2 aldoxorubicin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 250 mg/m2 aldoxorubicin | DRUG | - |
| 350 mg/m2 aldoxorubicin | DRUG | - |
| 170 mg/m2 aldoxorubicin | DRUG | administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days |
Inclusion Criteria: 1. Age 18 years or older; male or female 2. Histologically or cytologically confirmed unresectable GBM. Subjects with recurrent disease whose prior pathology demonstrated GBM will not need to be re-biopsied. Subjects with prior low-grade glioma or anaplastic glioma are eligible ...
M2 aldoxorubicin is an investigational oncology drug being studied for glioblastoma and for metastatic, locally advanced, or unresectable soft tissue sarcoma. It is developed by ImmunityBio, Inc. (IBRX) and is currently in Phase 2 clinical development.
M2 aldoxorubicin is developed by ImmunityBio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker IBRX. The drug is being investigated for use in oncology, specifically for glioblastoma and soft tissue sarcoma.
M2 aldoxorubicin is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for safety and efficacy.
M2 aldoxorubicin has been studied in two completed clinical trials. NCT02014844 was a Phase 2 study in glioblastoma with 28 participants, and NCT02235701 was a Phase 1 study in metastatic, locally advanced, or unresectable soft tissue sarcoma with 70 participants.
Yes, M2 aldoxorubicin is also known as aldoxorubicin. The drug is referred to by both names in clinical trial records and research contexts.