Colon

INCA033890-303: A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

MOA: INCA33890 is a Fc-silenced, IgG1 bispecific antibody that can simultaneously bind to both PD-1 and TGFβR2.

Key Eligibility Criteria:

• Histologically or cytologically confirmed metastatic colorectal adenocarcinoma not amenable to curative resection
• No prior systemic treatment for unresectable or metastatic CRC
  • Subjects who previously received neoadjuvant and/or adjuvant therapy
• Subjects must have radiographically measurable disease per RECIST v1.1
• Subjects must have availability of results for MSI-H/dMMR status, KRAS mutation status, and BRAF V600E mutation status
  • Subjects with known MSI-H/dMMR status or BRAF V600E mutation are excluded
  • Retrospective MSI and/or MMR status will be assessed centrally
  • Subjects that received treatment with an anti–PD-(L)1, anti–CTLA-4 antibody, or any other drug specifically targeting T-cell costimulation or checkpoint pathways within the past 3 years are excluded

A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

MOA: Pumitamig (BMS-986545/BNT327) is a bispecific antibody targeting PD-L1 and VEG-F.

Key Eligibility Criteria:

• Previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery
• MSI-H/dMMRand BRAF V600E excluded per local testing​
• KRASand NRASmutation status must have been
  documented prior to randomization in Phase 2
• Adjuvant or neoadjuvant chemotherapy must be completed(>
  6 months) before diagnosis of recurrent or metastatic disease
• Subjects are excluded that have received prior systemic treatment specifically targeting T cell co-stimulation or checkpoint pathways: an anti-PD-1,anti-PD-L1/2, CD137 agonists​ or an anti-CTLA-4 antibody

A Phase II Study Investigating Fruquintinib plus FOLFIRI as Second-Line Treatment for Participants with Metastatic Colorectal Cancer (mCRC)

MOA: Fruquintinib is a highly selective and potent VEGFR inhibitor.

Key Eligibility Criteria:

• Subjects must have confirmed mCRC
• Genetic aberrations are allowed, excludes MSI-H and BRAF V600
• Subjects must have received 1L therapy that included oxaliplatin, a
  fluoropyrimidine, and a BEV-based agent
  • FOLFOXIRI + BEV and SOX + BEV regimens not permitted
  • Must have completed minimum of 2 cycles of first-line therapy
• Subjects that received more than 1 prior systemic treatment or any
  treatment including FOLFIRI or irinotecan-based therapy are
  excluded
• Participants who received neo/adjuvant oxaliplatin and a
  fluoropyrimidine and progressed within 6 months are not eligible due
  to lack of BEV exposure
• ECOG score ≤ 2

Phase II, Multicenter, 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 Tumors  

MOA: Zongertinib is an EGFR wild-type sparing, selective HER2 inhibitor with potent inhibitory activity on all oncogenic HER2 mutations.

Key Eligibility Criteria:

• Subjects with a previously treated, locally advanced unresectable or metastatic solid tumor & a documented HER2 status of:
  • Cohorts 1-6, 11, & 12: HER2 overexpression (IHC3+, IHC 2+ and amplification by ISH+) or amplification (NGS in tissue, NGS and IHC/ISH in blood)
  • Cohorts 7-10 & 13: Known activating HER2 mutations (without overexpression/amplification)
• Subjects must have documented progression after at least one prior therapy (excluding adjuvant/neoadjuvant), and deemed unlikely to benefit from further SOC treatment
• Patients with HER2 overexpressing/amplified mBC or HER2 mutant NSCLC(except where there is co-existing presence of HER2 overexpression/amplification) are excluded
• Patients previously treated with HER2 TKIs are excluded