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Also known as Aldoxorubicin HCl
Aldoxorubicin · 5 trials · 5 indications
PFS is defined as the time from the date of randomization to first documentation of objective tumor progression, according to RECIST 1.1 Criteria, or to death due to any cause in the absence of previous documentation of objective tumor progression. For subjects without documentation of objective tumor progression, who started other anti-tumor treatment, or lost to follow up/withdrew consent prior to confirmed progression, PFS is censored at the date of the last tumor assessment. PFS is defined as the interval from the date of randomization to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first. PD is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 new lesion is also considered PD.
The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with gemcitabine in subjects with metastatic solid tumors as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight.
Blood samples will be obtained for pharmacokinetics. Standard pharmacokinetic parameters, including t1/2, Cmax, AUC, Vd and CL, will be determined.
The primary objective of this study is to determine the preliminary safety and maximum tolerated dose (MTD) of aldoxorubicin plus doxorubicin HCl in subjects with advanced solid tumors who have failed standard therapies.
| Arm | Type | Description |
|---|---|---|
| Aldoxorubicin | EXPERIMENTAL | Aldoxorubicin is administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously on Day 1 every 21-day cycles until tumor progression or unacceptable toxicity occurs. |
| Investigator's Choice of Treatment | ACTIVE_COMPARATOR | These treatments include: 1. Dacarbazine administered at 1000 mg/m2 by intravenous infusion (IVI), over 90±15 minutes on Day 1 every 21 days until tumor progression or unacceptable toxicity occurs; 2. Pazopanib, 800 mg orally each day until tumor progression or unacceptable toxicity occurs; 3. Gemcitabine, 900 mg/m2 by IVI over 90 minutes on Days 1 and 8, plus docetaxel, 100 mg/m2 by IVI over 1 hour on Day 8 of a 28 day cycle until tumor progression or unacceptable toxicity occurs; 4. Doxorubicin, 75 mg/m2 by IVI over 5 to 30 minutes every 21 days for a maximum cumulative dose of 550 mg/m2 or unacceptable toxicity occurs; or 5. Ifosfamide 2.0 g/m2 administered over 2 to 4 hours on Days 1-4 of a 21 day cycle + mesna per standard site administration regimen until tumor progression or unacceptable toxicity occurs. |
| Topotecan | ACTIVE_COMPARATOR | - |
| Aldoxorubicin plus doxorubicin | EXPERIMENTAL | Aldoxorubicin dosages of 175, 240, and 320 (doxorubicin equivalents of 130, 180, and 240 mg/m2) will be administered as a 30 minutes IVI on Day 1 of each cycle. In addition 35 mg/m2 of doxorubicin HCl will be administered as an IVI over \> 3 minutes no later than 3 hours, but no more than 6 hours before the start of aldoxorubicin infusion. |
| Name | Type | Description |
|---|---|---|
| Aldoxorubicin | DRUG | - |
| Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide) | DRUG | - |
| Topotecan | DRUG | 1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs |
| gemcitabine | DRUG | - |
Inclusion Criteria: 1. Has provided written informed consent prior to any study related activities. 2. Age ≥15 years (US only), and 18-80 (rest of world (ROW)), male or female. 3. Histological confirmation of intermediate or high grade soft-tissue sarcoma. Tissue must be sent to a central pathology...
Aldoxorubicin is an investigational small molecule being studied for the treatment of metastatic solid tumors, advanced solid tumors, metastatic small cell lung cancer, and metastatic, locally advanced or unresectable soft tissue sarcoma. It is in Phase 2 clinical development for these oncology indications.
Aldoxorubicin targets TOP2A, also known as topoisomerase II alpha, and acts as an inhibitor of this molecular target. By inhibiting TOP2A, the drug is designed to interfere with cancer cell DNA replication and division, which is the basis for its antitumor activity in solid tumors.
Aldoxorubicin is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol IBRX. The company is advancing the drug through clinical trials for multiple oncology indications, including soft tissue sarcoma and solid tumors.
Aldoxorubicin is currently in Phase 2 clinical development. It has completed earlier phase trials, including Phase 1 studies and a Phase 3 study in soft tissue sarcoma. The drug remains investigational and has not been approved by regulatory authorities for any indication.
Aldoxorubicin has been studied in several clinical trials, including NCT01673438, a Phase 1b study in advanced solid tumors; NCT01706835, a pharmacokinetic study in advanced solid tumors; NCT02049905, a Phase 3 study in soft tissue sarcoma; and NCT02235688, a Phase 1 study combining aldoxorubicin with gemcitabine in metastatic solid tumors.
Yes, Aldoxorubicin HCl is another name for Aldoxorubicin. The hydrochloride salt form is often used in pharmaceutical preparations, and both names refer to the same investigational drug being developed by ImmunityBio for the treatment of various solid tumors.