Maintenance Zanzalintinib With Etoposide After HDCT in GCT

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06937866
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Germ Cell Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanzalintinib — DRUG
    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.
  • Etoposide Capsule — DRUG
    Oral daily for 21 days of each 28 day cycle.

Study Details

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.

Key Dates

Start date
Nov 12, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2030
Completion
Sep 30, 2031

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation
  • Experimental: Phase II Dose Expansion
    Patients will be added at highest zanzalintinib dose tolerated, 40mg or 60mg.

Primary Outcome Measure

Phase 1: Rate of hematologic toxicity [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Christine Snow, RN
[email protected]
317-274-5830
King Jennifer, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, IN

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