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Solid Tumor Clinical Trials

Solid Tumor

23328- A Phase II, multicentre, multicohort, open-label trial to evaluate the efficacy and safety of oral zongertinib (BI 1810631) for the treatment of selected HER2-mutated or overexpressed/amplified solid tumours (1479-0009)

  • Phase – II
  • Stage(s) – Advanced
  • Investigational Drug – Zongertinib
  • Drug Class – TKI
  • Mechanism of Action – Zongertinib is an EGFR wild-type sparing, selective HER2 inhibitor with potent inhibitory activity on all oncogenic HER2 mutations
  • Biomarker(s) – HER2-mutated or overexpressed/amplified tumors
  • Sponsor – Boehringer Ingelheim

19151- A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001)
STAR TRIAL = 2 WEEKS TO OPEN – 4 SLOTS REMAINING FOR PHASE 2, COHORT D PATIENTS (EXCLUDING NSCLC, CRC, AND APPENDICEAL)
OPEN AT MEDIA

  • Phase – I, II
  • Investigational Drug – MRTX849 (adagrasib)
  • Drug Class – KRAS G12C inhibitor
  • Mechanism of Action – small molecule inhibitor of KRAS G12C
  • Biomarker(s) – KRAS G12C

22067- Phase 1/2 Study of PRO1184 in Patients with Locally Advanced and/or Metastatic Solid Tumors: Breast Endometrial Ovarian Lung Mesothelioma – 22067- (PRO1184-001) NCT:05579366

  • Phase – 1/2
  • Stage(s) – III, IV
  • Lines of Therapy – 1-3 lines
  • Investigational Drug – PRO1184
  • Drug Class – ADC
  • Mechanism of Action – folate receptor alpha (FRα) targeted antibody-drug conjugate
  • Biomarker(s) – cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer, breast cancer (hormone receptor positive, HER2-negative, and triple-negative), mesothelioma
  • Sponsor – Provision for Medicine; Profound BIO

20186- Tumor-agnostic Precision Immuno-oncology and somatic targeting rational for you – 20186-Tapistry- BO41932-NCT04589845

  • Phase – II
  • Stage(s) – III, IV
  • Lines of Therapy – All
  • Investigational Drug – Entrectinib
  • Drug Class – TKIs
  • Mechanism of Action – Entrectinib: binds to and blocks NTRK
  • Biomarker(s) – NTRK 1/2/3
  • Sponsor – Roche

22037- A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) (PMV-586-101) – 22037 NCT04585750
STAR TRIAL = 2 WEEKS TO OPEN

  • Phase – 2
  • Stage(s) – Locally Advanced or Metastatic
  • Lines of Therapy – must have received prior SOC, Second line
  • Investigational Drug – PC14586
  • Mechanism of Action – C14586, a first-in-class selective p53 reactivator, is designed to stabilize the mutated p53 Y220C protein, in which tyrosine is substituted by cysteine at amino acid 220 of the protein
  • Biomarker(s) – TP53 Y220C

23253- Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors (CDRB436IIC01)
STAR TRIAL = 2 WEEKS TO OPEN

  • Phase – IV
  • Stage(s) – metastatic
  • Investigational Drug – Dabrafenib, Trametinib
  • Drug Class – Dabrafenib = enzyme inhibitor; Trametinib = kinase inhibitor
  • Mechanism of Action – Dabrafenib is an RAF kinase inhibitor. Trametinib is an allosteric inhibitor of MEK1/2 and kinase activity
  • Biomarker(s) – BRAF V600E mutation positive