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    DRUG CLASS:

    KRAS G12D degrader

    Related drugs:
    8d
    3082-CL-0101: A Study of ASP3082 in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=681, Recruiting, Astellas Pharma Inc | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2027 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • carboplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • leucovorin calcium • setidegrasib (ASP3082)
    14d
    UNLOCK ASP3082: Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance (clinicaltrials.gov)
    P2, N=60, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • BRAF mutation • KRAS G12D • RET fusion • RET mutation • ROS1 fusion • MET mutation • KRAS G12 • NTRK fusion
    |
    setidegrasib (ASP3082)
    16d
    Setidegrasib in Advanced Non-Small-Cell Lung Cancer and Pancreatic Cancer. (PubMed, N Engl J Med)
    Setidegrasib was associated with antitumor activity and a low incidence of treatment discontinuation due to adverse events in patients with previously treated advanced KRAS p.G12D-mutated NSCLC or pancreatic ductal adenocarcinoma. (Funded by Astellas Pharma; ClinicalTrials.gov number, NCT05382559.).
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    setidegrasib (ASP3082)
    20d
    UNLOCK ASP3082: Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Gustave Roussy, Cancer Campus, Grand Paris
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • BRAF mutation • KRAS G12D • RET fusion • RET mutation • ROS1 fusion • MET mutation • KRAS G12 • NTRK fusion
    |
    setidegrasib (ASP3082)
    22d
    ARV-806-101: A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation (clinicaltrials.gov)
    P1/2, N=51, Recruiting, Arvinas Inc. | N=14 --> 51
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    25d
    ARV-806-101: A Study to Evaluate the Safety and Tolerability of ARV-806 in Adults with Advanced Cancer that has the KRAS G12D Mutation (2025-521062-10-00)
    P1, N=14, Not yet recruiting, Arvinas Operations Inc.
    New P1 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    1m
    A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer (clinicaltrials.gov)
    P3, N=614, Recruiting, Astellas Pharma Global Development, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • setidegrasib (ASP3082) • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
    1m
    A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults (clinicaltrials.gov)
    P1, N=54, Recruiting, Astellas Pharma Global Development, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    setidegrasib (ASP3082) • itraconazole
    1m
    3082-CL-0101: A Study of ASP3082 in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=681, Recruiting, Astellas Pharma Inc | Trial completion date: Oct 2026 --> Dec 2027 | Trial primary completion date: Oct 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • carboplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • leucovorin calcium • setidegrasib (ASP3082)
    2ms
    CSET 2025/4116: Phase 2, Multicenter, Open label, Platform Study investigating ASP3082 in patients with Metastatic/Locally Advanced Non-Small-Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), with biomarker analysis to characterize response/resistance (UNLOCK ASP3082) (2025-522533-54-00)
    P1/2, N=60, Not yet recruiting, Institut Gustave Roussy
    New P1/2 trial
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • BRAF mutation • KRAS G12D • RET fusion • RET mutation • ROS1 fusion • MET mutation • KRAS G12 • NTRK fusion
    |
    setidegrasib (ASP3082)
    2ms
    A Study to Confirm the Safety of ASP3082, and if it Delays Tumor Growth in People With Pancreatic Cancer, When Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies (clinicaltrials.gov)
    P3, N=614, Not yet recruiting, Astellas Pharma Global Development, Inc.
    New P3 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • setidegrasib (ASP3082) • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
    2ms
    A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults (clinicaltrials.gov)
    P1, N=54, Not yet recruiting, Astellas Pharma Global Development, Inc.
    New P1 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    setidegrasib (ASP3082) • itraconazole