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Current Clinical Trials

Breast

17079- FLEX-NCT03053193-Agendia
MammaPrint, Blueprint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene Expression Profiles: An Adaptable Registry

  • Stage(s) – I, II, III

22101- EMBER-4 – J2J-MC-JZLH-NCT05514054-ELI LILLY
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

  • 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- VIKTORIA-1- CELC-G-301-NCT05501886-Celcuity
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- DYNASTY-Breast02-DB-1303-O-3002- NCT06018337-IQVIA
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

Endometrial

22272- KRT-232-118 –NCT05797831-Kartos Therapeutics; GOG 3089
A Phase 2 Study of Navtemadlin as Maintenance Therapy in subjects with TP53WT Advanced or Recurrent Endometrial Cancer who responded to Chemotherapy

  • Phase – II, III
  • Stage(s) – II-IV
  • Line of Therapy – 2nd+
  • Investigational Drug – Navemadlin
  • Drug Class – MDM2 Inhibitor
  • Mechanism of Action – Navtimadlin binds to the MDM2
  • Biomarker(s) – TP53WT

Esophageal

23172- TAS-120-206 NCT05945823-Syneos Health
A Phase 2 Study of FUTIBATINIB (Lytgobi Kinase inhibitor) in Combination with PD-1 Antibody-based Standard of Care Therapy in Patients with Solid Tumors (squamous cell carcinoma of the esophagus)

  • Phase – II
  • Stage(s) – III, IV
  • Line of Therapy – First line
  • Investigational Drug – Futibatinib
  • Drug Class – Kinase Inhibitor
  • Mechanism of Action – inhibiting FGFR phosphorylation and, in turn, downstream signaling in FGFR-deregulated tumor cell lines
  • Biomarker(s) – PDL-1

Leukemia

18263- BGB-3111-215-NCT04116437-Beigene
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

21498- RAMP 203- VS-6766-203-NCT05074810-Verastem Inc
Avutometinib (VS-6766) in Combination with Sotorasib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC)

  • 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- FURMO-004-NCT05607550-Arrivent Biopharma, Inc
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

22322- SUNRAY-01-NCT06119581-Lilly
Patients with KRAS G12C, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing:

LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1 expression >= 50%

LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum regardless of PD-L1 Expression

  • Phase – III
  • Stage(s) – III, IV
  • Line of Therapy – FIRST LINE
  • Investigational Drug – LY3537982
  • Drug Class – Inhibitor of GTP bound KRAS 12C inhibitor

23074- (SGN-B6A-002)-NCT06012435-Phase 3 Evaluating SGN-B6A (integrin beta 6 targeted antibody) Compared with Docetaxel for Adult Subjects with Previously Treated (2+ Lines) Whose Disease Has Progressed After Treatment with Pd-[L]1 Inhibitors, Platinum-Based Chemotherapy, And/or Targeted Therapy

  • Phase – 3
  • Stage(s) – 3
  • Line of Therapy – 2+
  • Investigational Drug – SGN-B6A
  • Drug Class – Targeted antibody
  • Mechanism of Action – A vedotin antibody Drug Conjugate directed to integrin Beta 6 for multiple carcinoma indications.
  • Biomarker(s) – NA
  • Sponsor – Seagen

Pancreatic

19151- 849-001-NCT03785249-Mirati Therapeutics, Inc
Adagrasib (MRTX849) in Patients with PDAC 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

23229- TTX-030-003-NCT06119217-Trishula Therapeutics, Inc
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

20186- Tapistry- BO41932-NCT04589845-Roche Laboratories, Inc
Tumor-agnostic Precision Immuno-oncology and somatic targeting rational for you

  • Phase – II
  • Stage(s) – III, IV
  • Line of Therapy – All
  • Investigational Drug – Alectinib Divarasib Entrectinib Camonsertib
  • Drug Class – TKIs
  • Mechanism of Action – Entrectinib: 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) – NTRK 1/2/3 ALK

22123- 1403-0011-NCT05512377-STAR-Boehringer Ingelheim
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

20412- LIBRETTO-432-J2G-MC-JZJX–NCT04819100–STAR–Eli Lilly
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- BO42777-NCT05170204-STAR-Roche Laboratories, Inc
Alectinib Compared with Durvalumab in Patients with Locally Advanced, Unresectable, 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