CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 39 enrolled
Drug / intervention
Navtemadlin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03217266
NCT03217266Phase 1Completed
CompareCT.gov

A Phase Ib Trial of Neoadjuvant AMG 232 (KRT-232) Concurrent With Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS)

National Cancer Institute (NCI)·interventional·Posted Jul 14, 2017·Updated Sep 23, 2025

In Brief

A Phase 1 clinical trial evaluating Navtemadlin, Radiation Therapy, and 1 other intervention for Resectable Soft Tissue Sarcoma and Soft Tissue Sarcoma. Completed, enrolled 39 participants across 53 sites.

Detailed Summary

This phase Ib trial studies the side effects of navtemadlin and radiation therapy in treating patients with soft tissue sarcoma. Navtemadlin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving navtemadlin and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsResectable Soft Tissue Sarcoma, Soft Tissue Sarcoma
CountriesUnited States
CollaboratorsNRG Oncology

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 14, 2017
Enrollment StartJun 20, 2018
Primary CompletionAug 27, 2023
Study CompletionSep 4, 2025
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.0 years ago

Interventions

Navtemadlindrug

Given PO

Radiation Therapyradiation

Undergo radiation therapy

Surgical Procedureprocedure

Undergo surgery