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New drug shows promise for Hard-to-Treat cancers with specific gene flaw

NCT ID NCT04174716

Disease control Sponsor: Idience Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called IDX-1197 in 108 adults with solid tumors that have a specific gene change (HRR mutation) and who had no other good treatment options. The goal was to find the safest dose and see if the drug could shrink tumors. The trial was completed, but results are not yet public.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

108 people

The number who actually took part.

Started

Nov 2019

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Homologous recombination deficiency Homologous recombination repair gene mutation Solid tumors

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Cha University Bundang Medical Center

    Seongnam-si, 13496, South Korea

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • Dong-a University Hospital

    Busan, 49201, South Korea

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 52727, South Korea

  • Inje University Haeundae Hospital

    Busan, 48108, South Korea

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • National Cancer Centre

    Goyang, Gyeongggi-do, 10408, South Korea

  • Pusan National University Yangsan Hospital

    Busan, 50612, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061, South Korea

  • Seoul National University Bundang Hospital

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

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

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

    Seoul, 06591, South Korea

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