Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
A1: AMG 386/kg+ Liposomal doxorubicin · 1 trial · 9 indications
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | In part 1, six subjects will be assigned to each cohort A or B. This is a dose escalation/de escalation study with a 6 + 3 design based on the incidence of DLTs (dose limiting toxicities) during the first 4 weeks of combined therapy \[(cohort A: AMG 386 and pegylated liposomal doxorubicin) or (cohort B: AMG 386 and topotecan)\]. |
| Part 2 | EXPERIMENTAL | The decision on declaration of a safe and tolerable dose during part 1 will lead to part 2 (cohort A: liposomal doxorubicin + AMG 386 MTD (max tolerated dose) of part 1, cohort B: Topotecan + AMG 386 MTD (max tolerated dose) of part 1 |
| Name | Type | Description |
|---|---|---|
| A1: AMG 386 10 mg/kg + Liposomal doxorubicin | DRUG | Liposomal doxorubicin 50 mg/m2 IV Q4W in combination with AMG 386 10 mg/kg IV QW |
| A3: AMG 386 15mg/kg + Liposomal doxorubicin | DRUG | A3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W |
| B1: AMG 386 10 mg/kg + Topotecan | DRUG | B1: AMG 386 10 mg/kg IV QW + Topotecan 4 mg/m2 IV days 1, 8, 15, of a 28 day dosing schedule |
| B3: AMG 386 15mg/kg + Topotecan | DRUG | AMG 386 15mg/kg IV QW + Topotecan 4mg/m2 IV days 1, 8, 15 of a 28 day dosing schedule |
Inclusion Criteria: * Histologically or cytologically documented recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer * Subjects must have received at least one platinum containing regimen * Radiographically documented progression per RECIST criteria with modification...
Top 2 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
A1: AMG 386/kg+ Liposomal doxorubicin is an investigational combination regimen studied in cancer, specifically advanced recurrent epithelial ovarian cancer and related gynecological malignancies. It pairs AMG 386 with pegylated liposomal doxorubicin. Amgen Inc. (AMGN) developed the combination, which has been tested in a single Phase 1 clinical trial.
A1: AMG 386/kg+ Liposomal doxorubicin was studied for advanced recurrent epithelial ovarian cancer, along with fallopian tube cancer, solid tumors, and other gynecological malignancies. The trial enrolled adult women with these advanced cancers. It remains an investigational regimen and is not an approved treatment.
Amgen Inc., which trades on Nasdaq under the ticker AMGN, is the developer of A1: AMG 386/kg+ Liposomal doxorubicin. The regimen combines Amgen's AMG 386 with pegylated liposomal doxorubicin, and Amgen sponsored the clinical trial evaluating the combination in advanced recurrent epithelial ovarian cancer.
A1: AMG 386/kg+ Liposomal doxorubicin is in Phase 1 development. One Phase 1 trial has been completed, and no active trials of this combination are ongoing. The regimen is investigational and has not been approved by the FDA for any indication.
A1: AMG 386/kg+ Liposomal doxorubicin was evaluated in the completed Phase 1 trial NCT00770536, titled AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR. That controlled study enrolled 103 female participants aged 18 years and older across the United States, Australia, and Belgium.