AB928CSP002: A Phase I/Ib Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Breast and Gynecologic Malignancies (AB928CSP002)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study sponsor: Arcus Biosciences, Inc.
Locations: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This study will help us understand whether a potential new treatment, AB928, can be safely given in combination with chemotherapy to subjects with cancer. AB928 will be evaluated in combination with a chemotherapy treatment Pegylated liposomal doxorubicin (PLD) or nanoparticle albumin-bound (nab)- paclitaxel (NP) with or without another experimental drug called IPI-549. AB928 and IPI-549 are considered investigational and are not approved by the U.S Food and Drug Administration (FDA).
– Female participants ≥ 18 years of age at the time of screening.
– Women with no childbearing potential because of surgery or at least 1 year post-menopause, or menopause confirmed by follicle-stimulating hormone testing.
– Must have at least 1 measurable lesion per RECIST v1.1.
– ECOG performance status score of 0 or 1.
– Must have archival tissue sample available for donation.
– Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product.
– Underlying medical conditions that, in the Investigator’s or Sponsor’s opinion, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs, or concurrent medical condition requiring the use of immunosuppressive medications or immunosuppressive doses of systemic or absorbable topical corticosteroids.
– Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
– Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of investigational product regimen.
– Baseline QT interval corrected with Fridericia’s method (QTcF) > 480 ms (average of triplicate readings).
Lisa Wahowske, RN BSN, OCN
NATALEE TRIO033 (NATALEE)
Principal Investigator: Rachel Lerner, MD
Study Sponsor: Novartis
Location: Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of study: A phase III multi center, randomized, open label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2 – early breast cancer.
– Patient is ≥ 18 years-old at the time of PICF signature
– Patient is female with known menopausal status at the time of PICF signature or initiation of adjuvant ET (whichever occurs earlier), or male.
– Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.
– Patient has breast cancer that is positive for ER and/or PgR
– Patient has HER2-negative breast cancer
– Patient has available archival tumor tissue from the surgical specimen
– Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and who belongs to one of the following categories (anatomic stage group II or III)
– If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
– If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines
– Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years
– Patient has received any CDK4/6 inhibitor
– Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk (“chemoprevention”) of breast cancer and/or treatment for osteoporosis within the last 2 years prior to PICF signature
– Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin. Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET
– Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
– Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET
– Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization
– Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies
– Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before PICF signature
– Patient has known HIV infection, Hepatitis B or C infection
– Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
– Patient is currently receiving any of the following substances within 7 days before randomization – Concomitant medications, herbal supplements, and/or fruits that are known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
– is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment
– Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
– Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
– Patient participated in another interventional study and received treatment with an investigational product (or used an investigational device) within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.
– Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
TAK 981-1002: An Open Label, Dose-Escalation, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, of TAK-981 in Adult Patients with Metastatic Solid Tumors or Lympho-mas (TAK 981-1002)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Takeda Pharmaceuticals
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of Study: The purpose of this study is to evaluate safety, tolerability and to identify the most appropriate dose of TAK-981 as treatment for patients with cancer. In addition, this study will also serve to obtain information on the amount of study drug in your blood after taking single and/or multiple doses of the study drug.
The main purposes of this study are:
– To determine if TAK-981 is safe in patients with cancer.
– To select the dose for future studies.
– To measure the amount of TAK-981 in your blood.
– To assess the anti-tumor effect of TAK-981.
– To assess how the research drug reaches its target protein (called SUMO activating enzyme). Small Ubiquitin-like
Modifier (or SUMO) proteins are proteins that attach and detach from other proteins. This happens in normal and
tumor cells to modify their function. SUMOylation is the process of adding these SUMO proteins to other proteins.
The process of SUMOylation allows growth of tumor cells, and prevents the immune system from attacking the
tumor. TAK-981 reduces SUMOylation, allowing the immune system to attack the tumor cells.
– To obtain information on how your body reacts to the study drug by looking at biomarkers. Biomarkers are
measurable substances that can be found in different tissues of your body like the blood, skin and the tumor.
– To determine if the amount of TAK-981 in your blood has any impact on your ECG results (heart function test).
TAK-981 is an investigational drug that has not yet been studied in humans. It has not been approved by the FDA (U.S. Food and Drug Administration) or other regulatory authorities for use by the general public. TAK-981 will be investigated in adult patients with metastatic solid tumors or lymphomas for which standard curative treatment or life-prolonging treatment does not exist, is no longer effective or if it cannot be tolerated or is not indicated for you.
– Adult male of female patients >/= 18 years old.
– Eastern Cooperative Group (ECOG) performance status of 0 to 1.
– Patients with histologically confirmed advanced (local regionally recurrent not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit, are intolerant or have refused them, OR
– Patients with relapsed/refractory lymphoma not amenable to therapies with proven clinical benefit or who are intolerant or who refuse them. Patients with low-grade lymphomas such as follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, and marginal zone lymphomas may not need to exhaust all available therapy.
– Adequate bone marrow reserve and renal and hepatic function.
– Treatment with systemic anticancer treatments or investigational products within 14 days before the first dose of study drug or 5 half-lives, whichever is shorter. Patients should have recovered from previous treatment toxicity to Grade 1, baseline (except alopecia and peripheral neuropathy), or the toxicity is considered established as a sequela.
– History of uncontrolled brain metastasis. Patients with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and the patients is receiving a corticosteroid dose ≤10 mg/day of prednisone equivalent at the time of receiving the first dose of TAK-981. For asymptomatic patients, screening brain imaging is not required.
– Patient has received extended field radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for limited field radiation for palliation), and who has not recovered to grade 1 or better from related side effects of such therapy (except for alopecia).
– Patient is receiving any live vaccine (eg, varicella, pneumococcus) within 4 weeks of initiation of study treatment.
– History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias of >Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
Lisa Wahowske, RN, BSN, OCN