Ziihera (zanidatamab-hrii)

P1/2, N=768, Recruiting, Boehringer Ingelheim | N=582 --> 768 | Trial completion date: Sep 2029 --> Jan 2029 | Trial primary completion date: Sep 2029 --> Jan 2029

P3, N=920, Active, not recruiting, Jazz Pharmaceuticals | Trial completion date: May 2026 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Jul 2026

P2, N=30, Not yet recruiting, Xijing Hospital

Zanidatamab, in combination with tislelizumab and CAPOX, demonstrated clinically meaningful antitumor activity with a manageable safety profile as first-line therapy for patients with HER2+ GC/GEJC. These results support further development of zanidatamab and tislelizumab with chemotherapy in this patient population in the ongoing phase 3 HERIZON-GEA-01 trial (NCT05152147).

P2, N=105, Active, not recruiting, UNICANCER | Not yet recruiting --> Active, not recruiting

Zanidatamab demonstrated efficacy and a manageable and tolerable safety profile with docetaxel as first-line treatment in patients with HER2-positive breast cancer. These data support the further development of zanidatamab in this patient population.

P2, N=25, Not yet recruiting, Fujian Medical University Union Hospital; Fujian Medical University Union Hospital

P1/2, N=52, Completed, Jazz Pharmaceuticals | Active, not recruiting --> Completed

If the tumour is unresectable, the recommended first-line treatment is cisplatin + gemcitabine + durvalumab a programmed cell death ligand 1 [PD-L1] inhibitor or pembrolizumab a programmed cell death protein 1 [PD-1] inhibitor. The development of targeted therapies has led to these treatments being recommended as second- or third-line therapy for patients with actionable gene alterations, while 5-fluorouracil-based chemotherapy is recommended for those without. Robust data support the use of ivosidenib in patients with IDH1 mutations (phase 3), and phase 2 trials showed efficacy of pemigatinib and futibatinib for patients with FGFR2 gene fusions, trastuzumab deruxtecan and zanidatamab for patients with HER2 overexpression/amplification, and dabrafenib + trametinib for patients with BRAFV600E mutations. It is hoped that wider dissemination of the content from this meeting will improve outcomes of patients with CCA by encouraging earlier referral, increasing the use of early molecular testing, an MDT approach, and maximising the use of targeted therapies. Continued efforts to raise awareness, implement education outreach opportunities, and involve patient advocacy groups are encouraged to improve CCA outcomes.

P2, N=125, Recruiting, Jazz Pharmaceuticals | Not yet recruiting --> Recruiting