^
    19d
    AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (clinicaltrials.gov)
    P1, N=500, Recruiting, Amgen | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • Lumakras (sotorasib) • pemetrexed • AMG 193
    22d
    A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (clinicaltrials.gov)
    P1, N=282, Recruiting, Amgen | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • AMG 193
    1m
    A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (clinicaltrials.gov)
    P1, N=282, Not yet recruiting, Amgen
    New P1 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • AMG 193
    2ms
    AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (clinicaltrials.gov)
    P1, N=500, Not yet recruiting, Amgen
    New P1 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • Lumakras (sotorasib) • pemetrexed • AMG 193
    2ms
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=527, Recruiting, Amgen | Trial completion date: Feb 2028 --> Mar 2029 | Trial primary completion date: Feb 2026 --> Nov 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    7ms
    AMG 193 Effective in Multiple Tumor Types. (PubMed, Cancer Discov)
    In a phase I trial of the MTA-cooperative PRMT5 inhibitor AMG 193, five of 39 patients with advanced MTAP-deleted solid tumors who had scans following initial treatment experienced partial responses. The responses occurred in five tumor types-esophageal, pancreatic, renal cell, gallbladder, and ovarian Sertoli-Leydig cell cancer.
    Journal
    |
    MTAP (Methylthioadenosine Phosphorylase) • PRMT5 (Protein Arginine Methyltransferase 5)
    |
    MTAP deletion
    |
    AMG 193
    8ms
    Initial results from first-in-human study of AMG 193, an MTA-cooperative PRMT5 inhibitor, in biomarker-selected solid tumors (AACR-NCI-EORTC 2023)
    No abstract available
    P1 data • Late-breaking abstract
    |
    PRMT5 (Protein Arginine Methyltransferase 5)
    |
    AMG 193
    8ms
    Initial results from first-in-human study of AMG 193, an MTA-cooperative PRMT5 inhibitor, in biomarker-selected solid tumors* (AACR-NCI-EORTC 2023)
    No abstract available
    P1 data
    |
    PRMT5 (Protein Arginine Methyltransferase 5)
    |
    AMG 193
    8ms
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=527, Recruiting, Amgen | N=386 --> 527 | Trial completion date: Feb 2027 --> Dec 2027 | Trial primary completion date: Mar 2025 --> Dec 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    9ms
    A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=184, Recruiting, Amgen | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    MTAP (Methylthioadenosine Phosphorylase)
    |
    MTAP deletion
    |
    IDE397 • AMG 193
    10ms
    A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=184, Not yet recruiting, Amgen
    New P1/2 trial • Combination therapy • Metastases
    |
    MTAP (Methylthioadenosine Phosphorylase)
    |
    MTAP deletion
    |
    IDE397 • AMG 193
    10ms
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=386, Recruiting, Amgen | Trial completion date: Apr 2028 --> Feb 2027 | Trial primary completion date: Aug 2025 --> Mar 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    1year
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=386, Recruiting, Amgen | Trial completion date: Jan 2028 --> May 2028 | Trial primary completion date: May 2025 --> Sep 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    1year
    The MTA-cooperative PRMT5 inhibitor AM-9747 exhibits robust antitumor activity in combination with clinically relevant chemotherapies and targeted agents in MTAP null tumor models (AACR 2023)
    AMG 193, currently in Phase 1 trials, and its representative analog AM-9747 have broad spectrum activity in MTAP null tumor models across hematologic and solid tumor indications...SOC agents representing a variety of mechanisms of action (paclitaxel, carboplatin, gemcitabine, pemetrexed, irinotecan, 5-FU) were evaluated and results ranged from strongly synergistic (CI<0.3) to additive (CI=1) in a panel of non-small cell lung carcinoma (NSCLC) and pancreatic cancer cell lines...To target both pathways we combined the FDA-approved KRAS G12C inhibitor sotorasib with AM-9747 and observed synergy (CI<0.6) in MIAPACA2 cells...This combination is being tested in additional MTAP null KRAS G12C mutant models. Overall, our data suggests that combining MTA-cooperative inhibitor AM-9747 with SOC or clinically relevant targeted agents is a compelling therapeutic strategy for the treatment of MTAP null cancers.
    Preclinical • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase) • PRMT5 (Protein Arginine Methyltransferase 5)
    |
    KRAS mutation • CDKN2A deletion
    |
    carboplatin • gemcitabine • paclitaxel • 5-fluorouracil • Lumakras (sotorasib) • pemetrexed • irinotecan • AMG 193
    1year
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=386, Recruiting, Amgen | Trial completion date: Dec 2026 --> Jan 2028
    Trial completion date
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    over1year
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=340, Recruiting, Amgen | Trial primary completion date: Feb 2025 --> May 2025
    Trial primary completion date • Combination therapy • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    over1year
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=340, Recruiting, Amgen | Trial completion date: Jul 2025 --> Nov 2026
    Trial completion date • Combination therapy
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    almost2years
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=340, Recruiting, Amgen | Trial primary completion date: Jul 2024 --> Dec 2024
    Trial primary completion date • Combination therapy
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    almost2years
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=340, Recruiting, Amgen | Trial primary completion date: Nov 2024 --> Jul 2024
    Trial primary completion date • Combination therapy
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    almost2years
    Design of a Phase 1 Study of AMG 193, an MTA-Cooperative PRMT5 Inhibitor, in Patients with Advanced MTAP-Null Solid Tumors (IASLC-WCLC 2022)
    This study is expected to enroll approximately 30 patients in Part 1a/b. This is the first FIH trial open for enrollment for this new class of PRMT5i and enrollment is ongoing.
    Clinical • P1 data
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase) • PRMT5 (Protein Arginine Methyltransferase 5)
    |
    CDKN2A deletion
    |
    AMG 193
    2years
    Design and rationale of a phase 1 dose-escalation study of AMG 193, a methylthioadenosine (MTA)-cooperative PRMT5 inhibitor, in patients with advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. (ASCO 2022)
    This study is expected to enroll approximately 30 patients in Part 1a/b. This is the first FIH trial open for enrollment for this new class of PRMT5i and enrollment is ongoing.
    Clinical • P1 data
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase) • PRMT5 (Protein Arginine Methyltransferase 5)
    |
    CDKN2A deletion
    |
    AMG 193
    2years
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=340, Recruiting, Amgen | Trial completion date: Nov 2024 --> Jun 2025
    Trial completion date • Combination therapy
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193
    2years
    AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov)
    P1/2, N=340, Recruiting, Amgen | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
    |
    docetaxel • AMG 193