NCT06937866

Maintenance Zanzalintinib With Etoposide After HDCT in GCT

Maintenance Zanzalintinib With Oral Etoposide Following High-dose Chemotherapy in Patients With Relapsed Metastatic Germ-cell Tumor

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single arm phase I/II trial of maintenance zanzalintinib in combination with oral etoposide in patients with relapsed GCT treated with HDCT and PBSCT with a safety lead-in cohort in patients with relapsed, refractory metastatic GCT.

Detailed description

This prospective, phase I/II trial will initially enroll 9 patients with relapsed, refractory metastatic disease. Two doses of zanzalintinib will be evaluated for toxicity. The patients will receive zanzalintinib orally daily continuously in combination with oral standard of care etoposide daily for 21 days out of 28 day cycles until time of progression or toxicity. The DLT period is 1 cycle of 28 days. We will employ the Bayesian optimal interval (BOIN) design to find the MTD.

Conditions

• Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	Zanzalintinib	Two zanzalintinib doses of 40mg and 60mg. The initial starting dose of zanzalintinib will be 40mg. The patients will receive zanzalintinib orally daily continuously for 28 day cycles.
DRUG	Etoposide Capsule	Oral daily for 21 days of each 28 day cycle.

Timeline

• Start date: 2025-11-12
• Primary completion: 2030-03-01
• Completion: 2031-09-01
• First posted: 2025-04-22
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study