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

NCT04174716 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ID-VDP-102
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Solid Tumors; Homologous Recombination Repair Gene Mutation; Homologous Recombination Deficiency

Keywords

HRR; 1197; venadaparib; IDX-1197

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IDX-1197

EXPERIMENTAL

Patient will be receive IDX-1197HCl once daily for 28 continuous days

Drug: IDX-1197

Interventions

IDX-1197 DRUG

Until progression or unacceptable toxicity develops

IDX-1197

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Idience Co., Ltd.: lead

Study Sites (19)

National Cancer Centre

Goyang, Gyeongggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 52727, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Inje University Haeundae Hospital

Busan, 48108, South Korea

Location

Dong-a University Hospital

Busan, 49201, South Korea

Location

Pusan National University Yangsan Hospital

Busan, 50612, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Cha University Bundang Medical Center

Seongnam-si, 13496, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 22, 2019
• Study Start: November 6, 2019
• Primary Completion: March 31, 2023
• Study Completion: June 28, 2024
• Last Updated: April 17, 2026

Record last verified: 2024-09

Locations

KR (19)