Sotorasib

Generic Name: Sotorasib

Brand Names: Lumakras, Lumykras

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₃₀F_₂N_₆O_₃

CAS Number: 2252403-56-6

Unique Ingredient Identifier: 2B2VM6UC8G

Background: Sotorasib, also known as AMG-510, is an acrylamide-derived KRAS inhibitor developed by Amgen. It is indicated in the treatment of adult patients with KRAS G12C mutant non-small cell lung cancer. This mutation makes up >50% of all KRAS mutations. Mutant KRAS discovered in 1982 but was not considered a druggable target until the mid-2010s. It is the first expe...

Indication: Sotorasib is indicated in the treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have received at least one prior systemic therapy.

Associated Conditions: Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer

Associated Therapies: -

Clinical Trials

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

Phase 2

Recruiting

Conditions: Colorectal Cancer
Resectable Colorectal Carcinoma

Interventions: Drug: Trastuzumab deruxtecan
Drug: Botensilimab
Drug: Durvalumab
Drug: Panitumumab
Drug: Balstilimab
Drug: Sotorasib

First Posted Date: 2023-05-06

Last Posted Date: 2023-09-21

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 112

Registration Number: NCT05845450

Locations: 🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Lombardia/MI, Italy

Ladarixin With Sotorasib in Advanced NSCLC - Phase II

Phase 2

Withdrawn

Conditions: Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

Interventions: Drug: Sotorasib
Drug: Ladarixin

First Posted Date: 2023-04-18

Last Posted Date: 2024-03-29

Lead Sponsor: NYU Langone Health

Registration Number: NCT05815186

Locations: 🇺🇸
NYU Langone Health, New York, New York, United States

Ladarixin With Sotorasib in Advanced NSCLC

Phase 1

Recruiting

Conditions: Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

Interventions: Drug: Sotorasib
Drug: Ladarixin

First Posted Date: 2023-04-18

Last Posted Date: 2024-03-29

Lead Sponsor: NYU Langone Health

Target Recruit Count: 40

Registration Number: NCT05815173

Locations: 🇺🇸
NYU Langone Health, New York, New York, United States

Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)

Phase 2

Recruiting

Conditions: Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Panitumumab
Drug: Sotorasib

First Posted Date: 2022-12-06

Last Posted Date: 2024-12-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 105

Registration Number: NCT05638295

Locations: 🇺🇸
Cancer Hematology Centers - Flint, Flint, Michigan, United States
🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
The Angeles Clinic and Research Institute - West Los Angeles Office, Los Angeles, California, United States

and more 135 locations

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Phase 2

Recruiting

Conditions: Metastatic HER2-Negative Breast Carcinoma
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Ovarian Carcinoma
Unresectable HER2-Negative Breast Carcinoma
Unresectable Malignant Solid Neoplasm
Advanced Malignant Solid Neoplasm

First Posted Date: 2022-10-03

Last Posted Date: 2024-12-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2900

Registration Number: NCT05564377

Locations: 🇺🇸
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States
🇺🇸
Corewell Health Dearborn Hospital, Dearborn, Michigan, United States
🇺🇸
Corewell Health Farmington Hills Hospital, Farmington Hills, Michigan, United States

and more 422 locations

A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Omeprazole
Drug: Sotorasib

First Posted Date: 2022-08-11

Last Posted Date: 2024-01-19

Lead Sponsor: Amgen

Target Recruit Count: 16

Registration Number: NCT05497557

Locations: 🇺🇸
Labcorp Clinical Research Unit Inc., Dallas, Texas, United States

SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

Phase 1

Terminated

Conditions: Metastatic Solid Tumor
Metastatic NSCLC
Non Small Cell Lung Cancer
Solid Tumor, Adult

Interventions: Drug: BBP-398
Drug: sotorasib

First Posted Date: 2022-07-29

Last Posted Date: 2024-12-12

Lead Sponsor: Navire Pharma Inc., a BridgeBio company

Target Recruit Count: 28

Registration Number: NCT05480865

Locations: 🇦🇺
Cancer Research SA, Adelaide, South Australia, Australia
🇦🇺
Southern Oncology Clinical Research Unit, Adelaide, South Australia, Australia
🇦🇺
Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia

and more 22 locations

An Open-label, Phase 2trial of Sotorasib in KRAS G12C-mutant Non-small-cell Lung Cancer(NSCLC) Patients and a Translational Study to Find Acquired Resistance Mechanism to Sotorasib

Phase 2

Not yet recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: sotorasib

First Posted Date: 2022-07-11

Last Posted Date: 2022-07-11

Lead Sponsor: Yonsei University

Target Recruit Count: 37

Registration Number: NCT05451056

Locations: 🇰🇷
Yonsei University Health System, Severance Hospital, Seoul, Korea, Republic of

Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy

Phase 2

Recruiting

Conditions: KRAS P.G12C
Non-small Cell Lung Cancer Stage III

Interventions: Drug: Sotorasib

First Posted Date: 2022-05-31

Last Posted Date: 2024-08-19

Lead Sponsor: Fundación GECP

Target Recruit Count: 43

Registration Number: NCT05398094

Locations: 🇪🇸
Complejo Hospitalario De Jaén, Jaén, Spain
🇪🇸
Hospital Parc Taulí, Barcelona, Spain
🇪🇸
Hospital Universitari Quiron Dexeus, Barcelona, Spain

and more 17 locations

VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer

Phase 1

Terminated

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: VIC-1911
Drug: sotorasib

First Posted Date: 2022-05-16

Last Posted Date: 2023-09-28

Lead Sponsor: Vitrac Therapeutics, LLC

Target Recruit Count: 4

Registration Number: NCT05374538

Locations: 🇺🇸
New York University Langone Health Perlmutter Cancer Cancer, New York, New York, United States
🇺🇸
University of California Davis, Sacramento, California, United States
🇺🇸
Emory University Winship Cancer Center, Atlanta, Georgia, United States

and more 2 locations

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