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

• ClinicalTrials.gov Identifier: NCT04174716
• Recruitment Status: Active, not recruiting
• First Posted: November 22, 2019
• Last Update Posted: March 1, 2023
• Sponsor: Idience Co., Ltd.
• Information provided by (Responsible Party): Idience Co., Ltd.

Tracking Information

• First Submitted Date: November 18, 2019
• First Posted Date: November 22, 2019
• Last Update Posted Date: March 1, 2023
• Actual Study Start Date: November 6, 2019
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2019)

objective response rate (ORR) [ Time Frame: Up to 24 weeks ]

Confirmed objective response rate (ORR) determined by the Investigator using Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

Drug: IDX-1197

Until progression or unacceptable toxicity develops

Study Arms

Experimental: IDX-1197

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

Intervention: Drug: IDX-1197

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: June 8, 2020): 310
• Original Estimated Enrollment (submitted: November 21, 2019): 420
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT04174716
• Other Study ID Numbers: ID-VDP-102
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Idience Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Idience Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Idience Co., Ltd.
• Verification Date: February 2023