Zanidatamab + Chemotherapy for Gastrointestinal Cancers

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Zymeworks Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).

Eligibility Criteria

This trial is for adults with advanced HER2-expressing gastrointestinal cancers, including gastroesophageal adenocarcinoma, biliary tract cancer, and colorectal cancer that can't be removed by surgery. Participants should have an ECOG score of 0 or 1 (which means they are fully active or restricted in physically strenuous activity but can do light work), no prior treatment with HER2-targeted agents, and no significant heart disease or untreated brain metastases.

Inclusion Criteria

My bile duct cancer is advanced and cannot be removed by surgery, and it tests positive for HER2.

My heart's left ventricle is functioning well.

My stomach cancer is advanced or has spread and tests show it is HER2 positive.

My colorectal cancer is advanced, cannot be surgically removed, and tests positive for HER2 without certain gene mutations.

My stomach cancer is advanced and cannot be removed by surgery, and it tests positive for HER2.

My cancer can be measured or observed.

I am fully active or can carry out light work.

Exclusion Criteria

I have been treated with a HER2-targeted therapy before.

My nerve damage does not severely affect my daily activities.

I do not have serious heart conditions or recent heart attacks.

I do not have any health conditions that prevent me from taking bevacizumab.

I don't have another cancer that could affect this treatment's safety or results.

I have a serious lung condition affecting the tissue and space around the air sacs.

Participant Groups

The study tests ZW25 (zanidatamab) combined with standard chemotherapy to see how safe it is and how well it works against certain gastrointestinal cancers. It's a Phase 2 trial where all participants receive the experimental drug plus one of several chemo regimens like Fluorouracil/Leucovorin with Bevacizumab or Gemcitabine/Cisplatin.

5Treatment groups

Experimental Treatment

Group I: ZW25 + mFOLFOX6 with bevacizumabExperimental Treatment5 Interventions

ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab

Group II: ZW25 + mFOLFOX6Experimental Treatment4 Interventions

ZW25 plus 5-FU, leucovorin, and oxaliplatin

Group III: ZW25 + XELOXExperimental Treatment3 Interventions

ZW25 plus capecitabine and oxaliplatin

Group IV: ZW25 + FPExperimental Treatment3 Interventions

ZW25 plus fluorouracil (5-FU) and cisplatin

Group V: ZW25 + CisGemExperimental Treatment2 Interventions

ZW25 plus cisplatin and gemcitabine