Biliary

22123
BI 907828 for treatment of patients with locally advanced/metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, & other select solid tumors

  • Phase – II
  • Stage(s) – III, IV
  • Line of Therapy – 2+
  • Investigational Drug – Brigimadlin(BI 907828)
  • Drug Class – MDM2-p53 Antagonist
  • Mechanism of Action – Inhibits the interaction between the p53 and MDM2 proteins
  • Biomarker(s) – MDM2

Breast

17079
MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Study)

  • Stage(s) – I, II, III

22101
Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence (EMBER-4)

  • Phase – III
  • Stage(s) – I, II, III
  • Line of Therapy – 2+
  • Investigational Drug – Imlunestrant (LY3484356)
  • Drug Class – SERD
  • Mechanism of Action – Antagonistic properties that cause continuous inhibition of ER-dependent gene transcription and cell growth
  • Biomarker(s) – ER+, HER2-

22159
Comparison of Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy

  • Phase – III
  • Stage(s) – III, IV
  • Line of Therapy – 2nd, 3rd
  • Investigational Drug – Gedatolisib(PF-05212384)
  • Drug Class – PI3K/mTOR Inhibitor
  • Mechanism of Action – Binds the different p110 catalytic subunit isoforms of PI3K and the kinase site of mTOR
  • Biomarker(s) – HR+, HER2-

23189
Study of DB-1303 Versus Investigator’s Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02) (DB-1303-O-3002)

  • Phase – III
  • Stage(s) – Advanced or Metastic
  • Line of Therapy – 1st, 2nd
  • Investigational Drug – DB-1303
  • Drug Class – Antibody Drug Conjugate
  • Mechanism of Action – Third-generation topoisomerase-1 inhibitor-based
  • Biomarker(s) – HER2-low expression-

Fallopian Tube

21270
ZN‑c3 in Subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

  • Phase – II
  • Stage(s) – Any
  • Line of Therapy – 2+
  • Investigational Drug – Azenosertib(ZN-c3)
  • Drug Class – WEE1 Inhibitor
  • Mechanism of Action – Drives cancer cells into mitosis without being able to repair damaged DNA

Leukemia

18263
Zanubrutinib (BGB-3111) in Patients with Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment with Acalabrutinib

  • Phase – II
  • Stage(s) – Any
  • Line of Therapy – 2+
  • Investigational Drug – Zanubrutinib(BGB-3111)
  • Drug Class – BTK Inhibitor
  • Mechanism of Action – Forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity

Lung

20412
Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC

  • Phase – III
  • Stage(s) – I, II, III
  • Line of Therapy – 2+
  • Investigational Drug – Selpercatinib (LY3527723)
  • Drug Class – RET Kinase Inhibitor
  • Mechanism of Action – Selectively binds to and targets various RET mutants and RET-containing fusion
  • Biomarker(s) – RET

21318
Alectinib Compared with Durvalumab in Patients with Locally Advanced, Unrectable, Stage III ALK Positive Non-Small Cell Lung Cancer after Concurrent or Sequential Chemoradiotherapy (BO42777)

  • Phase – III
  • Stage(s) – III
  • Line of Therapy – 2+
  • Investigational Drug – Alectinib (RO5424802)
  • Drug Class – ALK TKI
  • Mechanism of Action – Inhibits ALK and RET proteins by preventing their phosphorylation
  • Biomarker(s) – ALK

21498
Avutometinib (VS-6766) in Combination with Sotorasib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP 203)

  • Phase – II
  • Stage(s) – III, IV
  • Line of Therapy – 2nd, 3rd
  • Investigational Drug – Avutometinib(VS-6766)
  • Drug Class – MEK/RAF TKI
  • Mechanism of Action – Blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK
  • Biomarker(s) – KRAS G12C

22198
Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Exon 20 Insertion Mutations

  • Phase – III
  • Stage(s) – III, IV
  • Line of Therapy – 1st
  • Investigational Drug – Furmonertinib (AST2818)
  • Drug Class – EGFR TKI
  • Mechanism of Action – Irreversibly inhibits both EGFR sensitizing and T790M resistant mutations
  • Biomarker(s) – EGFR exon 20 insertion

Pancreatic

23229
An open-label multicenter 3-arm randomized Phase 2 study to assess the efficacy and safety of TTX-030 and chemotherapy with or without budigalimab, compared to chemotherapy alone, for the treatment of patients not previously treated for metastatic pancreatic adenocarcinoma

  • Phase – II
  • Stage(s) – Metastatic
  • Line of Therapy – First Line
  • Investigational Drug – TTX-030
  • Drug Class – anti-CD39 antibody
  • Mechanism of Action – potential first-in-class, anti-CD39 antibody. The trial will evaluate TTX-030 in combination with chemotherapy, with or without budigalimab (an investigational anti-PD-1 antibody), compared to chemotherapy alone, as first-line

Solid Tumor

19151
Adagrasib (MRTX849) in Patients with Advanced Solid Tumors (No CRC, appendiceal, or NSCLC) with KRAS G12C Mutation

  • Phase – I/II
  • Stage(s) – III, IV
  • Line of Therapy – All
  • Investigational Drug – Adagrasib (MRTX849)
  • Drug Class – KRAS G12C Inhibitor
  • Mechanism of Action – Selectively and irreversibly binds to the KRAS G12C locking it in the inactive GDP bound state
  • Biomarker(s) – KRAS G12C

20186
Tumor-agnostic Precision Immuno-oncology and somatic targeting rational for you (TAPISTRY)

  • Phase – II
  • Stage(s) – III, IV
  • Line of Therapy – All
  • Investigational Drug – Alectinib Divarasib Entrectinib Camonsertib
  • Drug Class – TKIs
  • Mechanism of ActionEntrectinib: binds to and blocks NTRK, ROS1 and anaplastic lymphoma kinase (ALK) overexpression
    Alectinib: Inhibits ALK and RET proteins by preventing their phosphorylation
    Divarasib: inhibits KRAS G12C
    Camonsertib: inhibits ATM SETD2
  • Biomarker(s) – ROS1, NTRK 1/2/3 ALK, KRAS G12C, ATM biallelic loss, SETD2

21236
Detecting cancers earlier through elective plasma-based CancerSEEK Testing– ascertaining serial cancer patients to enable new diagnostic II (DETECT-ASCEND 2) Open cohorts: HNSCC, Kidney/Renal, Liver, Bladder, Uterine, Stomach, Cervical, Ovarian, Vulva, Small Intestine, Thyroid, Testis

  • Stage(s) – Any
  • Investigational Drug – Alectinib (RO5424802

22052
Nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes

  • Phase – II
  • Stage(s) – III, IV
  • Line of Therapy – 2+
  • Investigational Drug – nab-Sirolimus (ABI-009)
  • Drug Class – mTOR Inhibitor
  • Mechanism of Action – Inhibition of mTOR
  • Biomarker(s) – TSC1, TSC2