Homologous Recombination Deficiency, Homologous Recombination Repair Gene Mutation, Solid Tumors
Conditions
Keywords
HRR, 1197, venadaparib, IDX-1197
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.
Interventions
DRUGIDX-1197
Until progression or unacceptable toxicity develops
Sponsors
Idience Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 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). |
Countries
South Korea
Outcome results
None listed