AMG 193 / Amgen 
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  • ||||||||||  AMG 193 / Amgen
    Trial completion date, Trial primary completion date:  A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC (clinicaltrials.gov) -  Nov 25, 2024   
    P2,  N=200, Not yet recruiting, 
    Trial completion date: Jun 2032 --> Oct 2031 | Trial primary completion date: Jun 2029 --> Oct 2028 Trial completion date: Sep 2029 --> Feb 2029 | Trial primary completion date: Sep 2027 --> Feb 2027
  • ||||||||||  AMG 193 / Amgen
    Phase 1b Study of AMG 193, An MTA-Cooperative PRMT5i, Alone and in Combination with Other Therapies in MTAP-deleted NSCLC (Exhibit Hall) -  Sep 8, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2887;    
    Subprotocol B (N ~ 94) will evaluate AMG 193 plus sotorasib in MTAP -deleted and KRAS G12C-mutated NSCLC...Patients will be required to have PD-L1-positive tumors in subprotocol A arm C, KRAS G12C-mutated tumors in subprotocol B, and active brain metastasis in subprotocol C. AMG 193 will be administered daily continuously. The study is expected to start recruitment in April 2024.
  • ||||||||||  AMG 193 / Amgen
    Trial completion date, Trial primary completion date:  A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors (clinicaltrials.gov) -  Aug 21, 2024   
    P1/2,  N=649, Recruiting, 
    The study is expected to start recruitment in April 2024. Trial completion date: Mar 2029 --> Dec 2027 | Trial primary completion date: Nov 2027 --> Mar 2026
  • ||||||||||  AMG 193 / Amgen
    Phase 1/2, Dose-expansion Study of AMG 193, an MTA-cooperative PRMT5 Inhibitor, In MTAP-deleted NSCLC (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2523;    
    18 years of age) with MTAP -deleted advanced tumors (determined by NGS or evidence of MTAP depletion determined by IHC); treatment with 1-3 prior lines of systemic therapy in the advanced/metastatic setting including platinum-based chemotherapy. Additionally, patients without actionable mutations must have received treatment with a PD(L)-1 inhibitor (unless contraindicated or PD-L1 < 1%), and patients whose tumors harbor actionable genomic aberrations (i.e. EGFR, ALK, MET, RET, ROS1, KRAS G12C ) should have disease progression on approved systemic therapies for these aberrations.
  • ||||||||||  AMG 193 / Amgen
    Trial completion date, Trial primary completion date:  AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (clinicaltrials.gov) -  Jul 17, 2024   
    P1,  N=500, Recruiting, 
    Additionally, patients without actionable mutations must have received treatment with a PD(L)-1 inhibitor (unless contraindicated or PD-L1 < 1%), and patients whose tumors harbor actionable genomic aberrations (i.e. EGFR, ALK, MET, RET, ROS1, KRAS G12C ) should have disease progression on approved systemic therapies for these aberrations. Trial completion date: Nov 2029 --> May 2032 | Trial primary completion date: Nov 2026 --> May 2029
  • ||||||||||  MTAP deleted cancer targeting synthetic lethal therapeutic / Ryvu Therap
    Discovery of novel MTA-cooperative PRMT5 inhibitors as targeted therapeutics for MTAP-deleted cancers (Section 24) -  Mar 5, 2024 - Abstract #AACR2024AACR_6897;    
    The correlation between compound exposure and on-target effect was confirmed in PK/PD and efficacy studies. Taken together, these studies confirm that MTA cooperative PRMT5 inhibitors exert strong synthetic lethal phenotype in MTAP deleted cancers and offer an exciting therapeutic opportunity for a large patient population.
  • ||||||||||  MTAP loss alters the epigenetic landscape and demonstrates superior therapeutic sensitivity to concomitant PRMT5 and PARP inhibition in cholangiocarcinoma (Section 22) -  Mar 5, 2024 - Abstract #AACR2024AACR_6873;    
    P1/2
    This renders selective targeting of MTAP null tumors with agents (MRTX1719, AMG193, TNG462, TNG908) targeting MTA bound PRMT5 (PRMT5:MTA), while sparing surrounding normal MTAP wild-type (WT) tissue...To address this pressing need, we co-treated CCA cell lines with MRTX1719 and PARP inhibitor olaparib...Similar differences in proportion of splicing events were also observed in MTAP loss CCA patient derived xenografts as compared to WT models. Collectively, these data implicate MTAP to be a crucial player in modulation of the chromatin and splicing events that may drive therapeutic response to PRMT5 inhibition.
  • ||||||||||  AMG 193 / Amgen
    Trial completion date, Trial primary completion date:  A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors (clinicaltrials.gov) -  Mar 2, 2024   
    P1/2,  N=527, Recruiting, 
    Collectively, these data implicate MTAP to be a crucial player in modulation of the chromatin and splicing events that may drive therapeutic response to PRMT5 inhibition. Trial completion date: Feb 2028 --> Mar 2029 | Trial primary completion date: Feb 2026 --> Nov 2027
  • ||||||||||  AMG 193 / Amgen
    Journal:  AMG 193 Effective in Multiple Tumor Types. (Pubmed Central) -  Dec 17, 2023   
    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.
  • ||||||||||  AMG 193 / Amgen
    Enrollment change, Trial completion date, Trial primary completion date:  A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors (clinicaltrials.gov) -  Sep 11, 2023   
    P1/2,  N=527, Recruiting, 
    The responses occurred in five tumor types-esophageal, pancreatic, renal cell, gallbladder, and ovarian Sertoli-Leydig cell cancer. N=386 --> 527 | Trial completion date: Feb 2027 --> Dec 2027 | Trial primary completion date: Mar 2025 --> Dec 2025
  • ||||||||||  AMG 193 / Amgen
    Trial completion date, Trial primary completion date:  A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors (clinicaltrials.gov) -  Jul 7, 2023   
    P1/2,  N=386, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Apr 2028 --> Feb 2027 | Trial primary completion date: Aug 2025 --> Mar 2025
  • ||||||||||  AMG 193 / Amgen
    Trial completion date, Trial primary completion date:  A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors (clinicaltrials.gov) -  Mar 31, 2023   
    P1/2,  N=386, Recruiting, 
    Trial completion date: Apr 2028 --> Feb 2027 | Trial primary completion date: Aug 2025 --> Mar 2025 Trial completion date: Jan 2028 --> May 2028 | Trial primary completion date: May 2025 --> Sep 2025
  • ||||||||||  5-fluorouracil / Generic mfg.
    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 (Section 19; Poster Board #16) -  Mar 14, 2023 - Abstract #AACR2023AACR_8449;    
    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.
  • ||||||||||  AMG 193 / Amgen
    Trial completion date:  A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors (clinicaltrials.gov) -  Feb 13, 2023   
    P1/2,  N=386, Recruiting, 
    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. Trial completion date: Dec 2026 --> Jan 2028
  • ||||||||||  TNG462 / Tango Therap
    TNG462 is a potential best-in-class MTA-cooperative PRMT5 inhibitor for the treatment of peripheral MTAP-deleted solid tumors (Exhibition Hall) -  Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_370;    
    Oral administration of TNG462 drives dose-dependent antitumor activity including durable tumor regressions and complete responses in multiple cell line- and patient-derived xenograft models. With enhanced potency and selectivity for MTAP-deleted cancer cells, and optimized pharmacokinetic properties to extend target coverage, TNG462 has the potential for broader and deeper clinical activity in peripheral MTAP-deleted solid tumors.
  • ||||||||||  AMG 193 / Amgen
    Trial primary completion date:  A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors (clinicaltrials.gov) -  Aug 12, 2022   
    P1/2,  N=340, Recruiting, 
    With enhanced potency and selectivity for MTAP-deleted cancer cells, and optimized pharmacokinetic properties to extend target coverage, TNG462 has the potential for broader and deeper clinical activity in peripheral MTAP-deleted solid tumors. Trial primary completion date: Jul 2024 --> Dec 2024
  • ||||||||||  AMG 193 / Amgen
    Trial completion date:  A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors (clinicaltrials.gov) -  Mar 14, 2022   
    P1/2,  N=340, Recruiting, 
    This is the first FIH trial open for enrollment for this new class of PRMT5i and enrollment is ongoing. Trial completion date: Nov 2024 --> Jun 2025