Colon

ROSETTA CRC-203: 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 - CA266-0003

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/dMMR and BRAF V600E excluded per local testing​
• KRAS and NRAS mutation 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
• Subjects with genetic aberrations are allowed
• No MSI-H and BRAF V600
• Subjects must have received FOLFOX and BEV-based first line of therapy
• Subjects that received more than 1 treatment regimen for mCRC are excluded
• Subjects that have received neo/adjuvant therapy and were disease free for >6 months before recurrence are eligible
• Subjects who received neo/adjuvant FOLFOX and progressed within 6 months are excluded
• ECOG score ≤ 2

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 

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/amplification
  • 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

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination with Pembrolizumab or Cetuximab in Patients with Advanced Solid Refractory/Resistant Malignancies (TTX-080-001)

MOA: TX-080 is an anti-HLA-G antibody that binds specifically to HLA-G and blocks engagement with ILT2 and ILT4 and reverses HLA-G-mediated immunosuppression.

Key Eligibility Criteria:

• Histologically or cytologically confirmed mCRC that is incurable
• Tumors must be MSS, WT for RAS, WT for BRAF, and HER2- negative
• Patients must be either:
  • 1L Setting: No prior systemic therapy for metastatic colorectal cancer.
  • 2L Setting: One prior regimen with 5-FU + oxaliplatin ± bevacizumab. Subjects may have received prior irinotecan allowed if used with 5-FU + oxaliplatin. Capecitabine counts as a 5-FU-based regimen.
• Subjects that received prior anti-EGFR therapy are excluded
• Must be eligible to receive cetuximab