Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: TAS0953/HM06
- drug: TAS0953/HM06
Eligibility
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 or liquid biopsy
- Documented progression of disease following existing therapies deemed by the
Investigator to have demonstrated clinical benefit or unable to receive such
therapies.
- 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:
- Locally advanced or metastatic non small cell lung cancer (NSCLC) patients with
primary 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Danielle Pancirer
+1 650-723-0186
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.