Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Conditions

• Colorectal Carcinoma
• Endometrial Carcinoma
• Melanoma
• Neuroblastoma
• Ovarian Carcinoma
• Pancreatic Ductal Adenocarcinoma
• Recurrent Desmoid Fibromatosis
• Recurrent Ewing Sarcoma
• Recurrent Hepatoblastoma
• Recurrent Hepatocellular Carcinoma
• Recurrent Malignant Solid Neoplasm
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Osteosarcoma
• Refractory Desmoid Fibromatosis
• Refractory Ewing Sarcoma
• Refractory Hepatoblastoma
• Refractory Hepatocellular Carcinoma
• Refractory Malignant Solid Neoplasm
• Refractory Non-Hodgkin Lymphoma
• Refractory Osteosarcoma
• Solid Pseudopapillary Neoplasm of the Pancreas
• Wilms Tumor

Eligibility Criteria

Sex

ALL

Age

12 Months - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Dual X-ray Absorptiometry — PROCEDURE
  Undergo DEXA scan
• Tegavivint — DRUG
  Given IV
• X-Ray Imaging — PROCEDURE
  Undergo x-ray imaging

Study Details

This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.

Key Dates

Start date

Nov 8, 2021

Status verified

Jan 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

147 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (tegavivint)
  Tegavivint will be administered IV over 4 hours on days 1, 8, and 15 of each cycle. Administer D5W flush after completion of each tegavivint infusion. Treatment repeats every 28 days for up to 26 cycles or 24 months in the absence of disease progression or unacceptable toxicity. Drug doses should be adjusted based on the weight (height and BSA will also be captured) measured within 7 days prior to the beginning of each cycle. The starting dose will be 5 mg/kg with dose levels for subsequent cohorts increasing to 6.5 mg/kg and 8 mg/kg if excessive toxicity does not occur. If the MTD has been exceeded at the first dose level, then the subsequent cohort of patients will be treated at a dose of 4 mg/kg. Patients undergo an x-ray at baseline, after cycle 1, and then every 3 cycles while on treatment and DEXA scan at baseline and every 6 cycles while on treatment, then at 12 months, 24 months, and annually up to 60 months following end of therapy.

Primary Outcome Measure

Frequency of dose limiting toxicities of tegavivint [ Time Frame: Up to 28 days ]

Locations (21)

Find similar trials in Birmingham, AL

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