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New treatment option for Metastatic Solid Tumor
Official title A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)
ClinicalTrials.gov ID: NCT05673928
What this study is testing
What is Trastuzumab emtansine?
Trastuzumab emtansine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic solid tumor.
Also referred to as T-DM1, Trastuzumab-MCC-DM1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if the study drugs, tucatinib and adotrastuzumab emtansine (T-DM1), can help to control solid tumors that have spread to the brain.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed HER2-positive metastatic solid tumor. HER2 positivity defined as HER2 overexpression by immunohistochemistry (IHC) 3+ or 2+...
- Patients must have one of the following on the screening brain MRI:
- Untreated brain metastases not requiring immediate local CNS therapy
- Previously treated brain metastases with progression of previous lesions or new lesions, but not requiring immediate local CNS therapy
- At least one measurable untreated brain lesion ≥0.5 cm and \<3.0 cm in the longest axis
You likely can't join if
- Patients must not have any of the following on the screening brain MRI:
- Any untreated brain lesions \>3.0 cm in size
- Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or...
- Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \>4 mg of dexamethasone (or equivalent).
- Poorly controlled (\>1/week) generalized or complex partial seizures, or manifestation of neurologic progression due to brain metastases...
- History of allergic reactions to trastuzumab or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 IRRs to...
See the full eligibility criteria
Who can join
- Histologically confirmed HER2-positive metastatic solid tumor. HER2 positivity defined as HER2 overexpression by immunohistochemistry (IHC) 3+ or 2+ and fluorescence in situ hybridization (FISH) positive and/or HER2...
- Patients must have one of the following on the screening brain MRI:
- Untreated brain metastases not requiring immediate local CNS therapy
- Previously treated brain metastases with progression of previous lesions or new lesions, but not requiring immediate local CNS therapy
- At least one measurable untreated brain lesion ≥0.5 cm and \<3.0 cm in the longest axis
- Prior SRS radiosurgery (must be completed within 7 days of study treatment initiation) is allowed as long as the previous treatment volume does not overlap with the current targets.
- Measurable (per the RECIST v1.1) or evaluable extracranial disease.
- Prior treatment with HER2-targeted treatments such as trastuzumab, pertuzumab, T-DM1, neratinib, lapatinib, or tucatinib is allowed, but not required. Patients with breast and gastric cancer must have received at least...
- Age ≥18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Appendix B).
- Life expectancy ≥3 months, in the opinion of the investigator.
- Adequate hematological and end-organ function, defined by the following laboratory test results, obtained within 28 days prior to study treatment initiation:
- Absolute neutrophil count ≥1,200/μL
- Platelet count ≥100,000/μL
- Hemoglobin ≥9g/dL
- Total bilirubin ≤1.5 × upper limit of normal (ULN), except for patients with known Gilbert's disease, who may enroll if conjugated bilirubin is ≤1.5 × ULN
- Transaminases (AST/ALT) ≤1.5 × ULN (≤5 × ULN if liver metastases are present)
- Creatinine level \<1.5 x ULN or estimated glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) study equation as applicable.
- International normalized ratio (INR) and partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) ≤1.5 × ULN, unless on medication known to alter INR and PTT/aPTT. Proprietary Information of MD...
- LVEF ≥50% as assessed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan documented within 3weeks prior to study treatment initiation.
- For patients of childbearing potential, as defined in Section 4.3, the following stipulations apply:
- Must have a negative serum or urine pregnancy test (minimum sensitivity of 25 mIU/mL or equivalent units of beta-human chorionic gonadotropin [β-hCG]) result within 3 days prior to study treatment initiation. A patient...
- Must agree not to try to become pregnant during the study and for at least 7 months after the final dose of study treatment
- Must agree not to breastfeed or donate ova starting at the time of informed consent and continuing through the study and for 7 months after the final dose of study treatment
- If sexually active in a way that could lead to pregnancy, must consistently use highly effective methods of birth control (i.e., methods that achieve a failure rate of \<1% per year when used consistently and correctly)...
- For patients who can father children, the following stipulations apply:
- Must agree not to donate sperm starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment
- If sexually active with a person of childbearing potential in a way that could lead to pregnancy, must consistently use a barrier method of birth control starting at the time of informed consent and continuing...
- If sexually active with a person who is pregnant or breastfeeding, must consistently use a barrier method of birth control starting at the time of informed consent and continuing throughout the study and for at least 7...
- The patient must provide written informed consent.
- Must be willing to undergo biopsy as required by the study, if clinically considered safe and feasible by the investigator.
What rules you out
- Patients must not have any of the following on the screening brain MRI:
- Any untreated brain lesions \>3.0 cm in size
- Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to the patient (e.g...
- Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \>4 mg of dexamethasone (or equivalent).
- Poorly controlled (\>1/week) generalized or complex partial seizures, or manifestation of neurologic progression due to brain metastases notwithstanding CNS-directed therapy.
- History of allergic reactions to trastuzumab or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 IRRs to trastuzumab that were successfully managed, or known allergy to any of the...
- Treatment with any systemic anticancer therapy or investigational agent within 5 half-lives (of the drug) or within 21 days (whichever is shorter ) prior to study treatment initiation.
- Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:
- Alopecia;
- Neuropathy, which must have resolved to ≤ Grade 2;
- Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely.
- Clinically significant cardiopulmonary disease such as:
- Ventricular arrhythmia requiring therapy
- Symptomatic hypertension or uncontrolled asymptomatic hypertension as determined by the investigator
- Any history of symptomatic CHF, left ventricular systolic dysfunction, or decrease in LVEF
- Severe dyspnea at rest (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] ≥ Grade 3) due to complications of advanced malignancy or hypoxia requiring supplementary oxygen therapy
- Grade 2 or greater corrected QT interval (QTc) prolongation on screening electrocardiogram (ECG).
- Known myocardial infarction or unstable angina within 6 months prior to study treatment initiation.
- Unable for any reason to undergo contrast MRI of the brain.
- Have used a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to study treatment initiation. Concomitant use of strong CYP3A4...
- Known carrier of hepatitis B or hepatitis C virus or has other known chronic liver disease.
- Known positive human immunodeficiency virus status.
- Patients who are pregnant, breastfeeding, or planning to become pregnant from the time of informed consent until 7 months after the last dose of study treatment.
- Unable to swallow pills or has significant GI disease that would preclude adequate oral absorption of medication.
- Other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact patient safety or compliance with study procedures.
- Evidence within 1 year of the start of study treatment of another malignancy that required systemic treatment.
- Patients who are eligible for the HER2CLIMB-02 study (NCT03975647) and they can be enrolled in that study.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.