Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (VASTUS) (VASTUS)

An Open-label, Multi-center, Phase 1b/2a Basket Trial of IDX-1197 in Patients With Homologous Recombination Repair Mutated Solid Tumors

This study is a Phase 1b/2a basket trial to assess safety and efficacy of IDX-1197 in patients with HRR mutation.

There are two parts to this study: Phase 1b, IDX-1197 dose-selection study to determine RP2D and Phase 2a, non-randomized parallel dose expansion study to confirm RP2D.

Study Overview

• Status: Completed
• Conditions: Solid Tumors; Homologous Recombination Deficiency; Homologous Recombination Repair Gene Mutation
• Intervention / Treatment: Drug: IDX-1197

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea, 49201
    • Dong-A University Hospital
  • Busan, South Korea, 50612
    • Pusan National University Yangsan Hospital
  • Busan, South Korea, 48108
    • Inje University Haeundae Hospital
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seongnam-si, South Korea, 13496
    • CHA University Bundang Medical Center
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 07061
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Gyeongggi-do
    • Goyang, Gyeongggi-do, South Korea, 10408
      • National Cancer Centre
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
  • Gyeongsangnam-do
    • Jinju, Gyeongsangnam-do, South Korea, 52727
      • Gyeongsang National University Hospital
  • Jeollanam-do
    • Hwasun, Jeollanam-do, South Korea, 58128
      • Chonnam National University Hwasun Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed cancers that have HRR mutation and are failed to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
• Measurable disease according to RECIST, v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
• Must have recovered from all side effects of their most recent systemic or local treatment (<CTCAE grade 3)
• Life expectancy greater than 12weeks

Exclusion Criteria:

• Prior treatment with PARP inhibitors
• Symptomatic CNS metastases
• History of or known carcinomatous meningitis
• Concurrent administration of any anti-cancer therapies other than those administered in this study
• Pregnant or lactating women
• Refractory nausea and vomiting, malabsorption, total gastrectomy, external biliary shunt or significant bowel resection that would preclude adequate absorption.
• Uncontrolled medical illness (such as infection requiring treatment with intravenous antibiotics)
• Severe or unstable angina, myocardial infarction or ischemia requiring coronary artery bypass graft or stent within the previous 6 months, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to enrollment or New York Heart Association (NYHA) Class II to IV heart disease.
• Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
• Known hypersensitivity to IDX-1197 or any of the excipients of the product

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDX-1197; Patient will be receive IDX-1197HCl once daily for 28 continuous days	Drug: IDX-1197; Until progression or unacceptable toxicity develops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate (ORR)	Confirmed objective response rate (ORR) determined by the Investigator using Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1).	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Idience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): June 28, 2024

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: HRR; 1197; venadaparib; IDX-1197
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ID-VDP-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No