Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AMG 102
Rilotumumab · 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Rilotumumab is an investigational monoclonal antibody developed by Amgen Inc. for the treatment of advanced solid tumors. It is an HGF inhibitor that has been studied in oncology, including a Phase 1/1b trial in Japanese subjects with advanced solid tumors or advanced or metastatic gastric or gastroesophageal junction cancer.
Rilotumumab targets HGF, also known as hepatocyte growth factor. It is classified as an HGF inhibitor. By binding to HGF, the monoclonal antibody is designed to interfere with HGF-driven signaling in tumor cells. This mechanism was the basis for its study in advanced solid tumors and gastric or gastroesophageal junction cancers.
Rilotumumab is developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen sponsored the clinical program for the drug, including the Phase 1/1b study conducted in Japan. No other developer is associated with rilotumumab in the available program information.
Rilotumumab is in Phase 1 development. It is an investigational agent and is not approved for any indication. The clinical program includes one completed Phase 1/1b study, and no active trials are ongoing. The completed trial enrolled 21 participants and was conducted in Japan.
Rilotumumab has been studied in one completed clinical trial, NCT01791374. This Phase 1/1b study evaluated rilotumumab in Japanese subjects with advanced solid tumors or advanced or metastatic gastric or gastroesophageal junction cancer. It enrolled 21 participants, was controlled, was not randomized or double blinded, and included biomarker-selected patients.
Rilotumumab has been studied for advanced solid tumors, including advanced or metastatic gastric cancer and advanced or metastatic gastroesophageal junction cancer. It is an investigational therapy and is not approved for these or any other indications. Its clinical evaluation took place in a Phase 1/1b trial in Japan.