RET Gen Anormallikleri Olan İlerlemiş Solid Tümörlü Hastalarda RET İnhibitörü TAS0953/HM06 Çalışması

Sade dilde özet

Bu çalışma, TAS0953/HM06 adlı bir RET inhibitörü ilacın, RET geninde anormallik bulunan ilerlemiş solid tümörlü (advanced solid tumors) hastalardaki güvenliliğini ve etkisini araştırıyor. Çalışmaya, doku ya da kan biyopsisiyle RET gen anormalliği saptanmış, özellikle küçük hücreli dışı akciğer kanseri (non-small cell lung cancer) olan yetişkin hastalar alınmaktadır. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Katılımcı alıyor

Sponsor

Taiho Pharmaceutical Co., Ltd.

Müdahale

TAS0953/HM06, TAS0953/HM06

Başlangıç

16.12.2020

Tahmini bitiş

01.03.2031

Ülkeler

United States, Japan, South Korea

İlgili genler

Merkezler

• Orange, United States
• Stanford, United States
• Boston, United States
• Detroit, United States
• Grand Rapids, United States
• New York, United States
• New York, United States
• Nashville, United States
• Houston, United States
• Kashiwa-shi, Japan
• Sendai, Japan
• Okayama, Japan
• Hirakata-shi, Japan
• Osaka, Japan
• Shizuoka, Japan
• Chuo-ku, Japan
• Koto-ku, Japan
• Fukuoka, Japan
• Kanagawa, Japan
• Okayama, Japan
• Seoul, South Korea

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Ages Eligible for Study:

\- Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region)

Inclusion Criteria:

Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion:

* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
* Available RET-gene abnormalities determined on tissue biopsy or liquid biopsy. If deemed appropriate by the investigator, determination on a pleural cell block or cell pellet is also acceptable.
* Adequate hematopoietic, hepatic and renal function

Phase I Dose-Escalation - Specific inclusion criteria:

* Advanced solid tumors
* Measurable and/or non-measurable disease as determined by RECIST 1.1
* If patient has brain and/or leptomeningeal metastases, (s)he should be asymptomatic.

Phase I Dose-Expansion - Specific inclusion criteria:

* Patient with RET gene fusion :

  * Cohort 1, 3: locally advanced or metastatic NSCLC patients naïve to RET selective inhibitors and no prior systemic anti-cancer treatment. Patients who have been treated with neo-adjuvant or adjuvant chemotherapy may be included if it has been completed at least 6 months prior to the first dose of the study.
  * Cohort 2, 4: locally advanced or metastatic NSCLC patients with RET gene fusion and prior exposure to RET selective inhibitors.
* Measurable disease as determined by RECIST 1.1
* If patient has brain and/or leptomeningeal metastases,(s)he should have:

  * asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or
  * asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.

Phase II :

* Available RET-gene abnormalities determined on tissue or liquid biopsy
* Locally advanced or metastatic:

  * NSCLC patients with primary RET gene fusion and prior exposure to RET selective inhibitors;
  * NSCLC patients with RET gene fusion and without prior exposure to RET selective inhibitors
  * patients with advanced solid tumors that harbour RET gene abnormalities (other than NSCLC patients with primary RET gene fusions) and has failed all the available therapeutic options
* Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
* Measurable disease as determined by RECIST 1.1
* If patient has brain and/or leptomeningeal metastases,(s)he should have:

  * asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or
  * asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.
* Adequate hematopoietic, hepatic and renal function

Exclusion Criteria:

Common exclusion criteria for Phase 1 and Phase 2

* Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug
* Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug or planned major surgery during the course of study treatment.
* Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side effects of such therapy, in the opinion of the Investigator.
* Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension, according to the Investigator's opinion.
* QT interval corrected using Fridericia's formula (QTcF) \>470 msec; personal or family history of prolonged QT syndrome or history of Torsades de pointes (TdP). History of risk factors for TdP
* Treatment with strong CYP3A4 inhibitors within 1 week prior to the first dose of study drug or strong CYP3A4 inducers within 3 weeks prior to the first dose of study drug.

Phase I Dose-Expansion - and Phase II specific exclusion criteria:

* Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.