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    CANCER:

    Gastroesophageal Junction Adenocarcinoma

    Related cancers:
    1d
    PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) (clinicaltrials.gov)
    P=N/A, N=400, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial primary completion date • Tumor mutational burden • IO biomarker
    |
    TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    2d
    PRS-343-PCS_04_16: PRS-343 in HER2-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=85, Completed, Pieris Pharmaceuticals, Inc. | Trial completion date: Oct 2021 --> Dec 2023 | Trial primary completion date: Oct 2021 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    cinrebafusp alfa (PRS-343)
    2d
    Germline homozygosity and allelic imbalance of HLA-I are common in esophagogastric adenocarcinoma and impair the repertoire of immunogenic peptides. (PubMed, J Immunother Cancer)
    The high frequency of germline homozygosity in EGA patients suggests reduced cancer immunosurveillance leading to an increased cancer risk. Therapeutic targeting of allelic imbalance of HLA-I molecules should be considered in EGA.
    Journal • Tumor mutational burden
    |
    TMB (Tumor Mutational Burden) • CTAG1B (Cancer/testis antigen 1B)
    2d
    8951-CL-0104: A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma (clinicaltrials.gov)
    P=N/A, N=18, Completed, Astellas Pharma Inc | Phase classification: P1 --> P=N/A
    Phase classification • Metastases
    |
    CLDN18 (Claudin 18)
    |
    Vyloy (zolbetuximab)
    3d
    ApoA-I and ApoB levels, and ApoB-to-ApoA-I ratio as candidate pre-treatment biomarkers of pathomorphological response to neoadjuvant therapy in gastric and esophago-gastric junction adenocarcinoma. (PubMed, Pol Przegl Chir)
    After NAC tumor regression grade (TRG) was evaluated in resected specimens according to the Mandard's tumor regression grading system and correlated with pre-treatment ApoA-I and ApoB serum concentration, and ApoB-to-ApoA-I serum concentration ratio.</br> <b><br></b> We found a positive correlation of ApoA-I level and pR (95% CI: -0.863 to -0.467; P < 0.0001), a negative correlation of ApoB level and pR (95% CI: 0.445 to 0.857; P < 0.0001), a negative correlation of ApoB-to-ApoA-I ratio and pR (95% CI: 0.835 to 0.964; P < 0.0001).</br> <b><br></b> ApoA-I and ApoB levels, and ApoB-to-ApoA-I ratio are candidate pre-treatment predictors of pR to NAC in GA and may help to guide personalized therapy.</br>Our work fits into the dynamically developing trend of personalized treatment. It describes a potentially important rationale for further evaluation of apolipoprotein A-I and apolipoprotein B as predictors of cancer response to neoadjuvant therapy.
    Journal
    |
    APOA1 (Apolipoprotein A-I) • APOB (Apolipoprotein B)
    5d
    Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=56, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Trodelvy (sacituzumab govitecan-hziy)
    5d
    Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment. (clinicaltrials.gov)
    P2, N=134, Not yet recruiting, Xiangdong Cheng
    New P2 trial • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab) • capecitabine • oxaliplatin
    6d
    KEYNOTE 900: Vactosertib in Combination With Pembrolizumab in Metastatic Colorectal or Gastric Cancer (clinicaltrials.gov)
    P1/2, N=120, Active, not recruiting, MedPacto, Inc. | Phase classification: P1b/2a --> P1/2 | N=67 --> 120 | Trial completion date: Aug 2023 --> Aug 2024 | Trial primary completion date: Jun 2021 --> May 2024
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • vactosertib (TEW-7197)
    6d
    A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=47, Terminated, Sumitomo Pharma America, Inc. | Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Sponsor's decision to terminate development of the program.
    Phase classification • Trial termination • Combination therapy • Checkpoint inhibition • Metastases
    |
    MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-B (Major Histocompatibility Complex, Class I, B)
    |
    MSI-H/dMMR • HLA-A*02 • HLA-A*24
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)
    6d
    Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) ( KEYVIBE-001) (clinicaltrials.gov)
    P1, N=492, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Oct 2024 --> Aug 2024 | Trial primary completion date: Oct 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • etoposide IV • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
    6d
    TPST-1495-001: Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=175, Active, not recruiting, Tempest Therapeutics | Recruiting --> Active, not recruiting | Phase classification: P1a/1b --> P1 | Trial primary completion date: Apr 2024 --> Sep 2024
    Enrollment closed • Phase classification • Trial primary completion date • Combination therapy
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Keytruda (pembrolizumab) • TPST-1495
    6d
    Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery (clinicaltrials.gov)
    P1/2, N=31, Completed, Mayo Clinic | Active, not recruiting --> Completed | Trial completion date: May 2024 --> Oct 2023
    Trial completion • Trial completion date • Surgery • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • oxaliplatin • leucovorin calcium • fluorouracil topical
    6d
    Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002) (clinicaltrials.gov)
    P1, N=25, Active, not recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: Dec 2023 --> Jan 2025
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Tukysa (tucatinib)
    7d
    New therapeutic target molecules for gastric and gastroesophageal junction cancer. (PubMed, Int J Clin Oncol)
    Phase III and Ib/III trials of the FGFR2-targeted antibody bemarituzumab for G/GEJ cancer overexpressing FGFR2b are ongoing based on the promising result in a phase II trial, especially in cases with an FGFR2b positivity of ≥ 10%...CLDN18.2 is expressed in some G/GEJ tumors but lacks oncogenic driver potential, and the CLDN18.2-targeted antibody zolbetuximab prolonged the survival of CLDN18.2-positive G/GEJ cancer patients in phase III trials...Similarly, targeting of nondriver molecules such as DKK1, TROP2, and CEACAM5 is under investigation in early-stage clinical trials. This shift in focus from target molecules with driver potential to markers for precise drug delivery should increase the number of possible targets in G/GEJ cancer.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • FGFR2 (Fibroblast growth factor receptor 2) • CLDN18 (Claudin 18) • CEACAM5 (CEA Cell Adhesion Molecule 5) • DKK1 (dickkopf WNT signaling pathway inhibitor 1)
    |
    FGFR2 amplification • CLDN18.2 positive • FGFR2 overexpression • FGFR2b overexpression
    |
    Vyloy (zolbetuximab) • bemarituzumab (AMG 552)
    7d
    Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery (clinicaltrials.gov)
    P1/2, N=31, Active, not recruiting, Mayo Clinic | Phase classification: P1b/2 --> P1/2
    Phase classification • Surgery • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • oxaliplatin • leucovorin calcium • fluorouracil topical
    7d
    Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1, N=17, Completed, Turning Point Therapeutics, Inc. | Active, not recruiting --> Completed | N=42 --> 17
    Trial completion • Enrollment change • Metastases
    |
    MSI (Microsatellite instability) • CLDN18 (Claudin 18)
    |
    MSI-H/dMMR • CLDN18.2 expression • CLDN18.2 positive
    |
    BMS-986476
    9d
    Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial • Combination therapy
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • azenosertib (ZN-c3)
    10d
    High LINC00626 expression promotes esophagogastric junction adenocarcinoma metastasis: the mediating role of the JAK1/STAT3/KHSRP axis (PubMed, Nan Fang Yi Ke Da Xue Xue Bao)
    High LINC00626 expression promotes esophageal-gastric junction adenocarcinoma metastasis by activating the JAK1/STAT3/KHSRP signal axis.
    Journal
    |
    JAK1 (Janus Kinase 1) • STAT3 (Signal Transducer And Activator Of Transcription 3)
    12d
    Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, The PARAMMUNE Trial (clinicaltrials.gov)
    P2/3, N=224, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Mar 2024 --> Jun 2024
    Trial initiation date • Metastases
    |
    Opdivo (nivolumab) • paclitaxel • Cyramza (ramucirumab) • ABP 206 (nivolumab biosimilar)
    12d
    TusaRav-QT: Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=56, Terminated, Sanofi | Trial completion date: Aug 2024 --> Mar 2024 | Active, not recruiting --> Terminated; Tusamitamab ravtansine clinical development program is discontinued as CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival. The decision is not related to any safety concern.
    Trial completion date • Trial termination • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    tusamitamab ravtansine (SAR408701)
    14d
    Prognostic and predictive impact of sex in locally advanced microsatellite instability high gastric or gastroesophageal junction cancer: An individual patient data pooled analysis of randomized clinical trials. (PubMed, Eur J Cancer)
    This pooled analysis including four randomized trials highlights a relevant impact of sex in the prognosis and treatment efficacy of MSI-high and MSS/MSI-low non-metastatic GC/GEJC.
    Clinical • Retrospective data • Journal • Microsatellite instability • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    14d
    Cost-utility of sintilimab plus chemotherapy vs chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction cancer in China. (PubMed, Expert Rev Pharmacoecon Outcomes Res)
    Sin+Chemo is a cost-effective first-line treatment option for advanced HER2-negative GC/GEJC in China. ORIENT-16, www.clinicaltrials.gov, identifier is NCT03745170.
    Journal • HEOR • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Tyvyt (sintilimab)
    14d
    A Study to Evaluate MK-2870 in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) (clinicaltrials.gov)
    P3, N=450, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Metastases
    |
    paclitaxel • docetaxel • irinotecan • Lonsurf (trifluridine/tipiracil) • sacituzumab tirumotecan (MK-2870)
    14d
    TranStar102: A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=320, Recruiting, Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Apr 2024 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • cisplatin • gemcitabine • paclitaxel • capecitabine • oxaliplatin • osemitamab (TST001)
    15d
    NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma (clinicaltrials.gov)
    P1, N=10, Terminated, NeoImmuneTech | Phase classification: P2 --> P1
    Phase classification • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Hyleukin-7 (efineptakin alfa)
    15d
    DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02) (clinicaltrials.gov)
    P2, N=79, Completed, Daiichi Sankyo | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    15d
    MATTERHORN: Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer (clinicaltrials.gov)
    P3, N=958, Active, not recruiting, AstraZeneca | Trial completion date: Feb 2025 --> Sep 2027 | Trial primary completion date: Feb 2025 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    Imfinzi (durvalumab) • docetaxel • oxaliplatin
    16d
    TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (clinicaltrials.gov)
    P2, N=23, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Mar 2024 --> Jul 2024
    Trial completion date • Combination therapy • Metastases
    |
    Cyramza (ramucirumab) • Lonsurf (trifluridine/tipiracil)
    16d
    Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells for Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P1, N=12, Recruiting, Peking University
    New P1 trial • CAR T-Cell Therapy
    16d
    Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q) (clinicaltrials.gov)
    P2, N=38, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    Kadcyla (ado-trastuzumab emtansine)
    20d
    A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy/Stereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +/- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies. (clinicaltrials.gov)
    P=N/A, N=150, Recruiting, Zhejiang Cancer Hospital
    New trial • Pan tumor • Metastases
    |
    Avastin (bevacizumab) • cisplatin • gemcitabine • Tyvyt (sintilimab) • capecitabine • albumin-bound paclitaxel • oxaliplatin
    20d
    Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=456, Recruiting, Sanofi | Trial completion date: Apr 2027 --> Nov 2026 | Trial primary completion date: Apr 2027 --> Nov 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • carboplatin • pemetrexed
    20d
    Study of PF-07265807 in Participants With Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=67, Active, not recruiting, Pfizer | Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2024 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Inlyta (axitinib) • sasanlimab (PF-06801591) • PF-07265807
    20d
    SGNB6A-001: A Study of SGN-B6A in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=824, Recruiting, Seagen Inc. | Trial completion date: Oct 2024 --> Oct 2028 | Trial primary completion date: Jul 2024 --> Nov 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • sigvotatug vedotin (SGN-B6A)
    20d
    Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer (clinicaltrials.gov)
    P2, N=94, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date • Metastases
    |
    paclitaxel • cixutumumab (IMC A12)
    20d
    LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib (clinicaltrials.gov)
    P3, N=545, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: May 2024 --> Aug 2024
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    lapatinib • capecitabine • oxaliplatin
    20d
    FOLFIRI Plus Durvalumab With or Without Tremelimumab in Second-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: The PRODIGE 59-FFCD 1707-DURIGAST Randomized Clinical Trial. (PubMed, JAMA Oncol)
    To determine the efficacy of 1 or 2 immune checkpoint inhibitors combined with FOLFIRI (leucovorin [folinic acid], fluorouracil, and irinotecan) in the treatment of advanced gastric/GEJ adenocarcinoma. Combination of immune checkpoint inhibitors with FOLFIRI in second-line treatment for advanced gastric/GEJ adenocarcinoma showed an acceptable safety profile but antitumor activity only in a subgroup of patients. ClinicalTrials.gov Identifier: NCT03959293.
    Clinical • Journal • Metastases
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Imfinzi (durvalumab) • 5-fluorouracil • Imjudo (tremelimumab) • irinotecan • leucovorin calcium
    20d
    AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov)
    P3, N=589, Recruiting, AstraZeneca
    New P3 trial
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • AZD0901
    21d
    A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma (clinicaltrials.gov)
    P3, N=610, Active, not recruiting, Akeso | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2024 --> Aug 2024
    Enrollment closed • Trial primary completion date • Metastases
    |
    capecitabine • oxaliplatin • Kaitanni (cadonilimab)
    21d
    DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy (clinicaltrials.gov)
    P2/3, N=90, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    22d
    Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, GC Cell Corporation
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    cyclophosphamide • fludarabine IV
    22d
    A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P3, N=506, Not yet recruiting, Akeso
    New P3 trial
    |
    paclitaxel • Kaitanni (cadonilimab) • pulocimab (AK109)