Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as rilotumumab
AMG 102 · 7 trials · 15 indications
The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.
Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.
Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.
DLTs are defined as grade 3 or higher adverse events that are related to rilotumumab during the first cycle of therapy. This does not include specific toxicities (eg nausea and vomiting) that are common in cancer patients unless specific criteria are met.
DLTs are defined as grade 3 or higher adverse events that are related to rilotumumab or the combination of rilotumumab and CX during the first cycle of therapy. This does not include specific toxicities (eg nausea and vomiting) that are common in cancer patients unless specific criteria are met.
| Arm | Type | Description |
|---|---|---|
| AMG 102 with Avastin | EXPERIMENTAL | Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks. |
| AMG 102 at 20 mg/kg Dose Level | EXPERIMENTAL | Up to 40 subjects will be treated at 20 mg/kg of AMG 102 Q2W (every 2 weeks) depending upon the stage of the study and number of responses observed. |
| AMG 102 at 10 mg/kg Dose Level | EXPERIMENTAL | Up to 40 subjects will be dosed at 10mg/kg of AMG 102 Q2W (every two weeks) based upon the stage of the study and number of responses observed. |
| AMG 102 and erlotinib | EXPERIMENTAL | Combination of AMG 102 and erlotinib |
| Rilotumumab Monotherapy | EXPERIMENTAL | Cohort 1A: Rilotumumab 10 mg/kg IV Q2W Cohort 1B: Rilotumumab 20 mg/kg IV Q2W Cohort 1C (if needed): Rilotumumab 15 mg/kg IV Q2W |
| Rilotumumab plus CX | EXPERIMENTAL | Cohort 2A: Rilotumumab 15 mg/kg IV Day 1 Q3W Cisplatin 80 mg/m2 IV (max of 6 cycles) Day 1 Q3W Capecitabine 1000 mg/m2 PO BID, Days 2-14 Q3W Cohort 2B (if needed): Rilotumumab 10 mg/kg IV Day 1 Q3W Cisplatin 80 mg/m2 IV (max of 6 cycles) Day 1 Q3W Capecitabine 1000 mg/m2 PO BID, Days 2-14 Q3W |
| Phase 2 Arm C | PLACEBO_COMPARATOR | AMG 102 placebo plus ECX |
| Phase 1b | OTHER | Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed. |
| Phase 2 Arm B | ACTIVE_COMPARATOR | AMG 102 at 7.5mg/kg plus ECX |
| Phase 2 Arm A | ACTIVE_COMPARATOR | AMG 102 at 15mg/kg plus ECX |
| Phase 1b - AMG 102 | OTHER | Phase 1b is an open-label study with AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed, will be administered by IV Q3W in combination with MP. |
| Phase 2 Arm A - AMG 102 + MP | EXPERIMENTAL | AMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W. |
| Phase 2 Arm C- PLACEBO | PLACEBO_COMPARATOR | Placebo in combination with MP, will be administered by IV Q3W. |
| Phase 2 Arm B - AMG 102 + MP | EXPERIMENTAL | Safe dose level in phase 1b of AMG 102 + MP will be administered by Q3W |
| Name | Type | Description |
|---|---|---|
| AMG 102 | DRUG | AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes. |
| Avastin | DRUG | Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102. |
| AMG 102 at 10 mg/kg | DRUG | AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks |
| AMG 102 at 20 mg/kg | DRUG | AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks |
| AMG 102 and erlotinib | DRUG | Dose Level -2 Dose level -1 Dose Level 0 AMG 102 5 mg/kg 7.5 mg/kg 15 mg/kg Erlotinib 150 mg 150 mg 150 mg The first cohort of patients in the phase I portion will start at dose level 0 of AMG102. |
| Rilotumumab | DRUG | Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells. |
| Capecitabine | DRUG | Administered at 625mg/m2 BID orally every day while on study. |
| Epirubicin | DRUG | Administered day 1 of each cycle at 50mg/m2 IV. |
| Cisplatin | DRUG | Administered day 1 of each cycle at 60mg/m2 IV. |
| Placebo | DRUG | AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution |
| Mitoxantrone | DRUG | Administered Q3W for a maximum of 12 cyles |
| Prednisone | DRUG | 5 mg orally BID |
Inclusion Criteria: * Patients must have recurrent histologically confirmed diagnosis of WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3 prior progressions. * Age ≥ 18 years. * Karnofsky ≥ 60%. * An interval of at least 4 weeks between either prior tumor b...
AMG 102 is an investigational oncology drug developed by Amgen Inc. (ticker AMGN). It has been studied in clinical trials for several cancer types, including advanced malignant glioma, glioblastoma multiforme, advanced renal cell carcinoma, non-small-cell lung cancer, and esophagogastric junction adenocarcinoma. It is in Phase 2 development and has not been approved by the FDA.
AMG 102 has been studied in clinical trials for advanced malignant glioma, glioblastoma multiforme, gliosarcoma, advanced renal cell carcinoma, non-small-cell lung cancer, gastric and esophagogastric junction cancer, and castrate-resistant prostate cancer. It is investigational and is not approved for any indication.
AMG 102 is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen sponsored the clinical trials evaluating AMG 102 both as a single agent and in combination regimens across multiple solid tumor types.
AMG 102 is in Phase 2 development. Its clinical program includes Phase 1 and Phase 2 studies, all of which are completed. The drug is investigational and has not received FDA approval for any cancer indication.
AMG 102 has been evaluated in completed trials including NCT01233687 with erlotinib in advanced non-small-cell lung cancer, NCT01113398 with Avastin in recurrent malignant glioma, NCT00770848 with mitoxantrone and prednisone in castrate-resistant prostate cancer, and NCT00719550 plus ECX in gastric or esophagogastric junction cancer.