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The primary Phase 1 purpose of this study is to assess overall safety and tolerability and recommended Phase 2 dose (RP2D) of APL-101-01 (SPARTA).

The Phase 2 portion will assess the efficacy of the dose determined in Phase 1 in individuals with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors.

Study Details

Age(s): 18 years and older

Condition or Disease: Solid Tumor, Advanced Cancer, Renal Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, NSCLC, Lung Cancer, Brain Tumor, Glioblastoma Multiforme

Intervention/Treatment: APL-101 Oral Capsules

Phase: Phase 2

Study Type: Interventional

Estimated Enrollment: 201

Primary Purpose: Treatment

Actual Study Start Date: September 27, 2017

Estimated Primary Completion Date: September 30, 2021

Estimated Study Completion Date: December 30, 2022 12:00 am

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General Information

Sponsor:
Apollomics Inc.

Trial Name:
Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

Trial Number:
APL-101-01 (Vebreltinib, formerly Bozitinib)

ClinicalTrials.gov Identifier:
NCT03175224

Recruitment Status:
Recruiting

First Posted:
June 5, 2017

Last Update Posted:
October 30, 2020

Website:
https://www.spartacancertrial.com/