^
    28d
    UmbrellaMAX: A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study (clinicaltrials.gov)
    P3, N=100, Recruiting, Hoffmann-La Roche | N=60 --> 100
    Enrollment change
    |
    Avastin (bevacizumab) • Rozlytrek (entrectinib) • ipatasertib (RG7440) • divarasib (RG6330) • Itovebi (inavolisib) • tiragolumab (RG6058)
    29d
    Engineered antibodies that stabilize drug-modified KRASG12C neoantigens enable selective and potent cross-HLA immunotherapy. (PubMed, Nat Commun)
    To address challenges by their low copy number, we develop AETX-R114, a T cell engaging bispecific antibody with picomolar affinity for MHC-restricted sotorasib-modified KRASG12C peptides presented by three HLA-A3 supertype alleles...To broaden the therapeutic potential of creating and targeting synthetic neoantigens, we further develop AETX-R302, which recognizes divarasib-modified KRASG12C peptides presented on alleles from the HLA-A2 and A3 supertypes. Cryo-EM structure determination reveals the molecular basis for breaking HLA supertype restriction. Collectively, our study illustrates how engineered antibodies can transform synthetic neoantigens into actionable cancer immunotherapy targets.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS G12C • KRAS G12
    |
    Lumakras (sotorasib) • divarasib (RG6330)
    2ms
    Krascendo 1: A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=320, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Lumakras (sotorasib) • Krazati (adagrasib) • divarasib (RG6330)
    2ms
    A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function (clinicaltrials.gov)
    P1, N=31, Completed, Genentech, Inc. | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Nov 2025 | Trial primary completion date: May 2026 --> Nov 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    divarasib (RG6330)
    2ms
    A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function (clinicaltrials.gov)
    P1, N=40, Active, not recruiting, Genentech, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    divarasib (RG6330)
    2ms
    Krascendo 170: A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=320, Recruiting, Hoffmann-La Roche | N=240 --> 320
    Enrollment change
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • divarasib (RG6330)
    3ms
    NAUTIKA1: A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=99, Recruiting, Genentech, Inc. | Trial completion date: Mar 2029 --> May 2030 | Trial primary completion date: Dec 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
    |
    PD-L1 expression • KRAS mutation • KRAS G12C • BRAF mutation • BRAF V600 • RET fusion • ALK fusion • RET mutation • ROS1 fusion • KRAS G12
    |
    Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • Rozlytrek (entrectinib) • Alecensa (alectinib) • Cotellic (cobimetinib) • Gavreto (pralsetinib) • divarasib (RG6330)
    3ms
    GO42144: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation (clinicaltrials.gov)
    P1, N=498, Active, not recruiting, Genentech, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Feb 2026 --> Sep 2026 | Trial primary completion date: Feb 2026 --> Sep 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • Tecentriq (atezolizumab) • erlotinib • divarasib (RG6330) • Itovebi (inavolisib) • migoprotafib (RLY-1971)
    4ms
    Krascendo 1: A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=320, Recruiting, Hoffmann-La Roche | Trial primary completion date: Sep 2026 --> Sep 2027
    Trial primary completion date
    |
    Lumakras (sotorasib) • Krazati (adagrasib) • divarasib (RG6330)
    4ms
    Krascendo 170: A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=240, Recruiting, Hoffmann-La Roche | Trial completion date: May 2027 --> Jan 2032 | Trial primary completion date: Sep 2025 --> Jan 2032
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • divarasib (RG6330)
    4ms
    Krascendo 2: A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=600, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • divarasib (RG6330)
    4ms
    BFAST: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2/3, N=1000, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Aug 2028 --> Oct 2026 | Trial primary completion date: Aug 2028 --> Oct 2026
    Trial completion date • Trial primary completion date • Tumor mutational burden
    |
    BRAF (B-raf proto-oncogene)
    |
    Avastin (bevacizumab) • cisplatin • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • carboplatin • gemcitabine • Rozlytrek (entrectinib) • docetaxel • Alecensa (alectinib) • Cotellic (cobimetinib) • pemetrexed • divarasib (RG6330)