Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma

Conditions

• Adipocytic Sarcoma
• Advanced Leiomyosarcoma
• Advanced Liposarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zanzalintinib — DRUG
  Supplied by Exelixis, Inc.
• Eribulin — DRUG
  1.1 mg/m\^2 dose.

Study Details

The investigators hypothesize that the combination of eribulin and zanzalintinib will be tolerable and lead to improved progression-free survival (PFS) as compared to eribulin alone based on historical data.

Key Dates

Start date

Oct 22, 2025

Status verified

May 2026

Primary completion

May 31, 2031

Completion

Apr 30, 2036

Study Design

Enrollment

18 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Level 1 (starting dose): Zanzalintinib + Eribulin
  Patients will receive zanzalintinib 40 mg by mouth once daily on Days 1 through 21 and eribulin intravenously on Days 1 and 8 of a 21-day cycle.
• Experimental: Dose Level 2: Zanzalintinib + Eribulin
  Patients will receive zanzalintinib 60 mg by mouth once daily on Days 1 through 21 and eribulin intravenously on Days 1 and 8 of a 21-day cycle.
• Experimental: Dose Level -1: Zanzalintinib + Eribulin
  Patients will receive zanzalintinib 20 mg by mouth once daily on Days 1 through 21 and eribulin intravenously on Days 1 and 8 of a 21-day cycle.

Primary Outcome Measure

Number of adverse events experienced by participants [ Time Frame: From start of treatment through 30 days after completion of treatment (estimated to be 25 months) ]

Central Contacts

• Mia C Weiss, M.D.
  314-747-3096
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

Related Studies

• Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma
  PHASE1/PHASE2 · Recruiting · National Cancer Institute (NCI) · Houston, Texas