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New treatment option for Advanced Endometrial Carcinoma
Official title IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05039801
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for advanced endometrial carcinoma.
Also referred to as ABP 215, Anti-VEGF.
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 find the highest tolerable dose of IACS-6274 that can be given alone, in combination with bevacizumab and paclitaxel, or in combination with capivasertib to patients who have solid tumors. The safety and tolerability of the study drug(s) will also be studied.
- Phase 1: an early, usually small safety study
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
- All Parts
- Provision of written informed consent prior to any study related procedures and compliance with the requirements and restrictions listed in the...
- Male or female patients ≥18 years of age at the time of study entry who agree to participate by giving written informed consent prior to...
- Histologically or cytologically confirmed advanced solid tumors, specifically: Dose Escalation for Part A may include: Patients with tumors harboring...
- Patients must have received at least one line of therapy for advanced stage disease and be refractory or ineligible to available existing...
You likely can't join if
- All Parts
- Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or...
- Known primary central malignancy or symptomatic central nervous system metastasis(es). Note: Patients with stable, previously treated brain...
- Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following cardiac conditions:
- Any unstable cardiac arrhythmia within 6 months prior to enrolment
- Prolongation of the Fridericia corrected QT (QTcF) interval defined as \>450 ms for males and \>470 ms for females
See the full eligibility criteria
Who can join
- All Parts
- Provision of written informed consent prior to any study related procedures and compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Male or female patients ≥18 years of age at the time of study entry who agree to participate by giving written informed consent prior to participation in any study related activities.
- Histologically or cytologically confirmed advanced solid tumors, specifically: Dose Escalation for Part A may include: Patients with tumors harboring actionable KEAP1/NFE2L2/STK11/NF1 mutations Patients with low ASNS...
- Patients must have received at least one line of therapy for advanced stage disease and be refractory or ineligible to available existing therapy(ies) known to provide clinical benefit for their condition.
- Prior treatment with chemotherapy, radiotherapy, immunotherapy or any investigational therapies must have been completed at least 3 weeks or at least five half lives, whichever is shorter, before the study drug...
- Fresh and/or archival tumor tissue from a biopsy obtained between the completion of the most recent line of treatment until study entry must be available for mutation and biomarker analysis. If available, archival tumor...
- Patients must have at least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessments.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Adequate organ function as indicated by the following laboratory values: Absolute neutrophil count (ANC) ≥1.0×109/L Platelets ≥100×109/L Hemoglobin ≥9.0 g/dL (\>5.59 mmol/L) Creatinine clearance (CrCl) \>50 mL/min...
- Adequate cardiac function with a left ventricular ejection fraction ≥50%
- Female patients of non childbearing potential, who are physiologically incapable of becoming pregnant, are eligible to enter and participate in the study if they: have had a hysterectomy, OR have had a bilateral...
- Female patients of childbearing potential, who are not post-menopausal or surgically sterile and intent to be sexually active with a non-sterile male partner, are required to use one form of highly effective...
- Non-sterile men, who are not sexually abstinent and intend to be sexually active with a woman of childbearing potential, must use a condom from the start of the trial and until 16 weeks after the last dose of treatment...
- Total/true abstinence is defined as a patient who refrains from any form of sexual intercourse, and this is in line with their usual and/or preferred lifestyle.
What rules you out
- All Parts
- Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder.
- Known primary central malignancy or symptomatic central nervous system metastasis(es). Note: Patients with stable, previously treated brain metastases may participate if neurologic symptoms have resolved, patients have...
- Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following cardiac conditions:
- Any unstable cardiac arrhythmia within 6 months prior to enrolment
- Prolongation of the Fridericia corrected QT (QTcF) interval defined as \>450 ms for males and \>470 ms for females
- History of any of the following cardiovascular conditions within 6 months of enrolment:
- cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New...
- Major surgical intervention within 28 days before study drug administration, or an anticipated need for major surgery during the study.
- Significant acute or chronic infections.
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Treatment with strong cytochrome P450 subtype 3A4 (CYP3A4) inducers and inhibitors (including grapefruit juice) within 2 weeks of the first dose of study drug NOTE: patients must have stopped taking St. John's Wort 3...
- Treatment with strong CYP450 subtype 2D6 (CYP2D6) inhibitors or sensitive CYP3A4 substrates within 7 days of the first dose of study drug.
- Radiotherapy within 4 weeks prior to the start of study drug. Palliative radiotherapy for symptomatic control is acceptable if completed at least 2 weeks prior to study drug administration and no additional radiotherapy...
- Underlying medical conditions (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant and active bleeding diseases), for which in the investigator's opinion will make the...
- History of allergic reactions attributed to compounds of similar chemical or biological composition to any of the compounds in the study.
- Known history of alcohol or drug abuse.
- Legal incapacity or limited legal capacity.
- Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses (such as...
- Patients unwilling to comply with protocol requirements related to the assigned part.
- Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an...
- Mean resting corrected QT interval \>470ms, obtained from triplicate ECGs performed at screening.
- Medical history significant for arrhythmia that is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation regardless of treatment, or asymptomatic sustained ventricular...
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia of Grade ≥1, potential for Torsades de Pointes, congenital long QT syndrome, family history of long...
- Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York...
- Uncontrolled hypotension: SBP \<90 mmHg and/or DBP \<50 mmHg.
- Cardiac ejection fraction outside institutional range of normal or \ 400 copies/mL and a CD4+ T-cell count of \<350 cells/uL or with a history of an acquired immunodeficiency syndrome (AIDS) opportunistic infection...
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.