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Also known as AMG 193, MTA Cooperative PRMT5 inhibitor
Anvumetostat · 5 trials · 7 indications
TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
An SAE is defined as any AE that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
Adverse events (AEs) are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs. Serious AEs (SAEs) are defined as any event that meets at least 1 of the following serious criteria: * Results in death (fatal) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Evaluation | EXPERIMENTAL | Participants will be randomized to receive one of 2 active dose levels of anvumetostat orally (PO) daily (QD) in 28 days cycles. Part 1 of the study will determine the recommended phase 2 dose (RP2D). |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will receive anvumetostat PO QD in 28-day cycles at the RP2D. |
| Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A | EXPERIMENTAL | Participants with MTAP-deleted NSCLC will receive a regimen of Anvumetostat orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV) |
| Subprotocol A: NSCLC Arm B | EXPERIMENTAL | Participants with MTAP-deleted NSCLC will receive a regimen of Anvumetostat PO and carboplatin, pemetrexed, and pembrolizumab IV |
| Subprotocol A: NSCLC Arm C | EXPERIMENTAL | Participants with MTAP-deleted NSCLC will receive a combination of Anvumetostat PO and pembrolizumab IV |
| Subprotocol B: NSCLC With KRasG12C Mutation | EXPERIMENTAL | Participants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of Anvumetostat and sotorasib PO |
| Subprotocol C: NSCLC With Brain Metastases | EXPERIMENTAL | Participants with MTAP-deleted NSCLC with brain metastases will receive Anvumetostat PO |
| Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A | EXPERIMENTAL | Part 1: Participants with MTAP-deleted PDAC will receive doses of Anvumetostat orally in combination with gemcitabine and nab-paclitaxel IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of Anvumetostat in combination with gemcitabine and nab-paclitaxel. |
| Subprotocol B: PDAC Arm B | EXPERIMENTAL | Part 1: Participants with MTAP-deleted PDAC will receive doses of Anvumetostat orally in combination with mFOLFIRINOX (irinotecan, fluorouracil, leucovorin calcium, oxaliplatin) IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of Anvumetostat in combination with mFOLFIRINOX. |
| Subprotocol C: Dose Exploration | EXPERIMENTAL | Part 1: Participants with MTAP-deleted PDAC will receive oral doses of Anvumetostat and RMC-6236. |
| Subprotocol C: Dose Expansion | EXPERIMENTAL | Part 2: Participants with MTAP-deleted PDAC will receive oral doses of Anvumetostat andRMC-6236. |
| Part 1: Dose Exploration of Anvumetostat Combined With IDE397 | EXPERIMENTAL | Participants will receive escalating doses of Anvumetostat and IDE397 administered orally (PO) in cycles of 21 days. |
| Part 2: Dose Expansion of Anvumetostat Combined With IDE397 | EXPERIMENTAL | Anvumetostat and IDE397 will be administered PO in cycles of 21 days. |
| Part 1a, Phase 1: Anvumetostat Monotherapy Dose Exploration | EXPERIMENTAL | Participants with MTAP-null solid tumors will receive escalating doses of Anvumetostat to estimate the MTD and/or the RP2D. |
| Part 1c, Phase 1: Anvumetostat Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive the identified MTD/RP2D of Anvumetostat in the following cohort: MTAP-null NSCLC. |
| Part 2a, Phase 1: Anvumetostat Dose Exploration + Docetaxel | EXPERIMENTAL | Participants with MTAP-null NSCLC will receive escalating doses of Anvumetostat + a fixed dose of docetaxel to estimate the MTD/RP2D of the combination. |
| Part 2b, Phase 1: Anvumetostat + Docetaxel Dose Expansion | EXPERIMENTAL | Participants with MTAP-null NSCLC will receive the identified MTD/RP2D of Anvumetostat + docetaxel. |
| Part 3: Anvumetostat Phase 2 | EXPERIMENTAL | Participants with MTAP-null solid tumors will receive Anvumetostat. |
| Part 1e, Phase 1: Anvumetostat Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null BTC. |
| Part 1f, Phase 1: Anvumetostat Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null head and neck squamous cell carcinoma (HNSCC). |
| Part 1g, Phase 1: Anvumetostat Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null pancreatic adenocarcinoma. |
| Part 1h, Phase 1: Anvumetostat Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null or lost MTAP expression solid tumors (other than lymphoma or primary brain tumor). |
| Part 1i, Phase 1: Anvumetostat Dose Optimization | EXPERIMENTAL | Participants will receive a randomized dose optimization evaluation of Anvumetostat. |
| Part 1j, Phase 1: Anvumetostat DSPS Substudy (US Sites Only) | EXPERIMENTAL | Participants will receive doses of Anvumetostat and comparator Anvumetostat test tables at different times in a fasted state. |
| Part 1k, Phase 1: Anvumetostat Food Effect Substudy (US Sites Only) | EXPERIMENTAL | Participants will receive Anvumetostat once on a fasted state and once after eating a standardized high-fat, high calorie meal. |
| Part 1l, Phase 1: Anvumetostat Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null esophageal/gastric cancer. |
| Part 1m, Phase 1: Anvumetostat Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null glioma. |
| Name | Type | Description |
|---|---|---|
| anvumetostat | DRUG | Film-coated tablet |
| Carboplatin | DRUG | Administered IV |
| Paclitaxel | DRUG | Administered IV |
| Pembrolizumab | DRUG | Administered IV |
| Pemetrexed | DRUG | Administered IV |
| Sotorasib | DRUG | Administered PO |
| Gemcitabine | DRUG | Administered IV |
| Nab-paclitaxel | DRUG | Administered IV |
| Modified FOLFIRINOX | DRUG | Modified FOLFIRINOX consists of irinotecan, 5-FU, LV, and oxaliplatin administered IV |
| RMC-6236 | DRUG | Administered orally |
| IDE397 | DRUG | Administered PO |
| Docetaxel | DRUG | Docetaxel: Intravenous infusion |
| Comparator Anvumetostat Test Tablet | DRUG | Comparator Anvumetostat test tablet: Orally via tablet. Only participants in the DSPS group of the Part 1a, Phase 1: Anvumetostat Monotherapy Dose Exploration, and Part 1j, Phase 1 arms will receive comparator Anvumetostat test tablet. |
Inclusion Criteria: * Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC * Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for...
Anvumetostat is an investigational small molecule oncology drug being developed by Amgen Inc. (NASDAQ: AMGN). It is being studied in biomarker-selected cancers, specifically tumors with homozygous MTAP deletion or MTAP-null status, including advanced gastrointestinal, biliary tract, pancreatic, thoracic, and non-small-cell lung cancers.
Anvumetostat is being studied for advanced gastrointestinal, biliary tract, and pancreatic cancers, advanced MTAP-null solid tumors, MTAP-deleted non-small-cell lung cancer, and advanced thoracic tumors. All of these are investigational uses in clinical trials; the drug is not approved for any indication.
Anvumetostat is being developed by Amgen Inc., which trades on NASDAQ under the ticker AMGN. Amgen is running the MTAPESTRY clinical program, which includes studies in MTAP-deleted non-small-cell lung cancer and other MTAP-deleted or MTAP-null advanced solid tumors.
Anvumetostat is in Phase 1 and Phase 2 clinical development. The Phase 1 studies include NCT06360354 in advanced gastrointestinal, biliary tract, or pancreatic cancers and NCT06333951 in advanced thoracic tumors, while the Phase 2 study NCT06593522 is in MTAP-deleted advanced non-small-cell lung cancer.
Anvumetostat has been studied across four trials. NCT06593522 is a Phase 2 study in MTAP-deleted advanced NSCLC. NCT06360354 and NCT06333951 are Phase 1 studies in MTAP-deletion gastrointestinal, biliary tract, pancreatic, and thoracic tumors. NCT05975073, a Phase 1/2 combination study with IDE397 in MTAP-null solid tumors, is completed.
Anvumetostat is not approved; it is an investigational drug still in clinical development. Its trials are listed as active but not recruiting, including the Phase 2 MTAPESTRY 201 study in MTAP-deleted advanced non-small-cell lung cancer and Phase 1 studies in MTAP-deleted gastrointestinal, biliary tract, pancreatic, and thoracic tumors.