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

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ClinicalTrials.gov Identifier: NCT04174716

Recruitment Status : Recruiting

First Posted : November 22, 2019

Last Update Posted : February 26, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Idience Co., Ltd.

Tracking Information

First Submitted Date ^ICMJE

November 18, 2019

First Posted Date ^ICMJE

November 22, 2019

Last Update Posted Date

February 26, 2021

Actual Study Start Date ^ICMJE

November 6, 2019

Estimated Primary Completion Date

September 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Solid Tumors
Homologous Recombination Repair Gene Mutation
Homologous Recombination Deficiency

Intervention ^ICMJE

Drug: IDX-1197

Until progression or unacceptable toxicity develops

Study Arms ^ICMJE

Experimental: IDX-1197

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

Intervention: Drug: IDX-1197

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

310

Original Estimated Enrollment ^ICMJE

420

Estimated Study Completion Date ^ICMJE

March 31, 2023

Estimated Primary Completion Date

September 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

19 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Won Sik Lee	82-2-526-3612	wonsiklee@idience.com
Contact: Minju Hong	82-2-526-3644	minju.hong@idience.com

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04174716

Other Study ID Numbers ^ICMJE

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 ^ICMJE

Plan to Share IPD:

Undecided

Responsible Party

Idience Co., Ltd.

Study Sponsor ^ICMJE

Idience Co., Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Idience Co., Ltd.

Verification Date

January 2021

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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