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NCT04174716 Clinical Trial

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

Solid Tumors Clinical Trial

— VASTUS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04174716
Other study ID # ID-VDP-102
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 6, 2019
Est. completion date December 31, 2023

Study information
Verified date February 2023
Source Idience Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 310
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

  • Homologous Recombination Deficiency
  • Homologous Recombination Repair Gene Mutation
  • Neoplasms
  • Solid Tumors

Intervention

Drug:
• IDX-1197
Until progression or unacceptable toxicity develops

Locations
Country Name City State
Korea, Republic of Dong-a University Hospital Busan
Korea, Republic of Inje University Haeundae Hospital Busan
Korea, Republic of Pusan National University Yangsan Hospital Busan
Korea, Republic of National Cancer Centre Goyang Gyeongggi-do
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun Jeollanam-do
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Gyeongsang National University Hospital Jinju-si Gyeongsangnam-do
Korea, Republic of Cha University Bundang Medical Center Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Idience Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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