Tennessee Oncology SC

Researchers are evaluating BGB-43395, a selective CDK4 inhibitor, as a single treatment and in combination with fulvestrant, letrozole, or elacestrant for participants with hormone receptor positive HR and HER2-negative breast cancer as well as other advanced solid tumors. This phase 1a1b study aims to determine the recommended dosing of BGB-43395 while assessing safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. The study has multiple parts Phase 1a involves dose escalation with increasing doses of BGB-43395 alone or combined with the other drugs to evaluate safety and tolerability. Selected dose levels then move to Phase 1a safety expansion cohorts with combinations in HRHER2- breast cancer. Phase 1b tests the recommended dose for expansion RFDE of BGB-43395 combined with fulvestrant or letrozole in HR breast cancer, including a subgroup receiving an anti-diarrheal agent to prevent side effects. Treatments are administered orally or by injection depending on the drug. Participants undergo regular monitoring for adverse events, dose tolerability, and response rates over up to approximately 60 months. Blood samples are taken to measure drug levels and metabolism during treatment cycles lasting 28 days. Researchers assess tumor response, disease control, and progression-free survival. The study also tracks safety events and collects pharmacokinetic data to guide dosing. Participation may last up to several years depending on treatment duration and follow-up assessments.

Researchers are evaluating ifinatamab deruxtecan I-DXd, a drug given for the first time to humans, in people with advanced solid tumors that have not been cured by other treatments. The study has two parts the first part aims to find the safest dose and the best dose for further study, while the second part focuses on assessing the drugs safety and its effect on tumors when used alone. This research is expected to last about five years from the first enrollment to the last participant finishing the study. Participants receive I-DXd through an intravenous IV infusion every three weeks. In the dose escalation part, participants received increasing doses to find the maximum tolerated dose this phase is now closed. The dose expansion part currently enrolls participants who receive the recommended dose determined earlier. Treatment cycles continue as long as participants benefit, do not withdraw, do not experience worsening disease, or unacceptable side effects. During the study, participants have regular evaluations including scans to measure tumor size, blood tests, and monitoring for side effects and immune reactions. Researchers track adverse events and study how the drug behaves in the body over several treatment cycles, each lasting 21 days. Safety and tumor response are closely observed until disease progression or after up to eight cycles. Participants may continue treatment beyond eight cycles if benefiting from the drug.

Researchers are evaluating AMXI-5001, an oral drug that blocks PARP and microtubule polymerization, in adults with advanced cancers that have not responded to other treatments. This Phase III trial aims first to find the best dose and then to study the drugs safety and effects in more detail. The study includes participants with several types of advanced cancers, including breast, ovarian, prostate, pancreatic, and other malignant tumors. The trial has two parts Phase I involves dose escalation, where up to 70 participants receive AMXI-5001 orally twice a day with food on a weekly continuous 7-day schedule, with each treatment cycle lasting 28 days. After determining the recommended dose, Phase II will enroll up to 52 participants to further assess safety, drug levels in the blood, and anti-tumor activity using the chosen dose. All participants receive the study drug as monotherapy. Participants will be monitored for safety, drug concentration in plasma, and tumor response using standard imaging and laboratory tests over approximately 24 months. The primary goals include finding the maximum tolerated dose and recommended dose for Phase II, as well as characterizing the safety profile. Participants must consent and meet eligibility criteria related to their cancer status and overall health. The trial will continue until about October 2026.

The trial investigates the effectiveness and safety of multiple therapies in participants with resectable stages IB, IIA, IIB, IIIA, or selected IIIB non-small cell lung cancer NSCLC tumors that meet specific biomarker criteria. This phase II study focuses on patients who have not been previously treated and aims to assess various targeted treatments based on tumor characteristics. Participants receive up to 8 weeks of neoadjuvant therapy with drugs such as alectinib, entrectinib, vemurafenib plus cobimetinib, pralsetinib, atezolizumab combined with stereotactic body radiation therapy SBRT, or divarasib before undergoing surgical resection according to standard care. After surgery, eligible participants with no disease progression or pathological response continue with adjuvant treatment, including chemotherapy cycles followed by up to 2 years of the respective study drug or other standard treatments depending on their cohort. Throughout the study, participants undergo clinical staging with CT, PET, and brain MRI scans, and evaluations including pathological response, adverse events, and survival outcomes. Researchers monitor tumor responses, disease-free and overall survival, and safety events for up to nine years. Treatment adherence, imaging, blood tests, and molecular analyses such as circulating tumor DNA clearance are part of the assessments during neoadjuvant, surgical, and adjuvant phases.

Researchers are evaluating a treatment for participants with untreated, unresectable, or metastatic melanoma at advanced stages Stage IIIC, IIID, or IV. This Phase 3, multicenter, open-label study compares a combination of lifileucel and pembrolizumab against pembrolizumab alone, focusing on efficacy and safety. The study includes participants who have not received prior therapy for metastatic disease, though some prior adjuvant or neoadjuvant therapies completed at least 6 months before progression are allowed. Participants in the study are assigned to one of two groups one receives pembrolizumab with lifileucel, and the other receives pembrolizumab alone. Lifileucel treatment involves surgically removing a tumor sample for manufacturing, followed by lymphodepletion, lifileucel infusion, and IL-2 therapy. Pembrolizumab is administered every 6 weeks until disease progression. Participants initially receiving pembrolizumab alone who experience confirmed disease progression may opt to receive lifileucel monotherapy in an optional crossover period. During the study, participants undergo tumor resection and regular treatment cycles. Researchers will assess outcomes such as objective response rate, progression-free survival, overall survival, complete response rate, duration of response, event-free survival, and adverse events over several years. Safety and efficacy are monitored throughout, with follow-up lasting up to 7 years to evaluate long-term outcomes and disease progression.

Researchers are evaluating DCSZ11, a monoclonal antibody, as a treatment for patients with advanced or metastatic solid tumors. This Phase 1, multicenter, open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential antitumor activity of DCSZ11 both alone and in combination with pembrolizumab. The study includes patients who have relapsed or refractory tumors and have limited or no effective standard therapy options. The study has two main phases Phase 1a Dose Escalation and Phase 1b Dose ExpansionOptimization. In Phase 1a, patients receive intravenous infusions of DCSZ11 every 3 weeks either as monotherapy or combined with pembrolizumab, with doses increased to find the maximum tolerated or planned dose. Phase 1b evaluates DCSZ11 combined with pembrolizumab or standard-of-care treatments like doxorubicin for soft tissue sarcoma and tebentafusp for uveal melanoma, using designs to optimize dosing and monitor safety continuously. Participants will undergo screening that includes biopsies, imaging, and laboratory tests to confirm eligibility and monitor response. Researchers will evaluate tumor response using established criteria such as RECIST and iRECIST over one year, and follow safety and survival outcomes for up to three years. The study involves regular clinic visits, safety assessments, and monitoring for immune responses and drug levels to understand treatment effects and tolerability.

This research aims to evaluate HER3-DXd monotherapy in adults with locally advanced unresectable or metastatic solid tumors who have previously received at least one systemic anticancer therapy. The study includes participants with various cancers such as melanoma, head and neck squamous cell carcinoma, HER2-negative gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, lung cancer, and breast cancer. The focus is to assess the treatments safety, tolerability, efficacy, and pharmacokinetics, along with exploring the relationship between HER3 protein expression and treatment response. Participants will receive intravenous infusions of HER3-DXd at a dose of 5.6 mgkg every three weeks Q3W. The trial is designed as a phase 2, multicenter, multicohort, open-label study involving a single treatment group receiving HER3-DXd monotherapy. Treatment continues until disease progression, unacceptable side effects, or withdrawal. The study will also collect tumor tissue samples before treatment to analyze HER3 protein expression. During the study, participants will undergo regular assessments including imaging scans to evaluate tumor response, safety evaluations, laboratory tests, and pharmacokinetic sampling at specified cycles. The primary outcomes include measuring objective response rates and, for prostate cancer participants, the proportion achieving significant decreases in PSA levels. Secondary outcomes cover treatment-emergent adverse events, duration of response, clinical benefit, disease control, progression-free survival, overall survival, and pharmacokinetic parameters. Participants will be followed for up to approximately 27 months to monitor these outcomes.

Researchers are evaluating REC-1245, an oral drug, in participants aged 12 and older with unresectable, locally advanced, or metastatic solid tumors, including some relapsed or refractory lymphomas. This open-label, multi-center study aims to assess the safety, tolerability, how the drug is processed in the body pharmacokinetics, and preliminary activity of REC-1245. The study includes both Phase 1 and Phase 2 portions, focusing on identifying appropriate dosing and measuring treatment effects over time. Participants will receive REC-1245 once daily by mouth for up to two years. The study has several groups, including dose-finding and multiple cohorts in Phase 1b and Phase 2, each receiving experimental doses of REC-1245. There is no use of placebo or blinding, and the treatment schedule is designed to monitor responses and side effects closely throughout the study duration. During the study, participants will undergo regular assessments including imaging scans like CT or MRI to measure tumor size, and evaluations of side effects from the start of treatment until up to 30 days after the last dose. Researchers will track key outcomes such as dose limiting toxicities, adverse events, and tumor responses over the treatment period of up to approximately 24 months. Safety and drug levels in the blood will be monitored intensively in early phases to guide dosing and evaluate tolerability.

Researchers are evaluating the safety, pharmacokinetics, and preliminary effectiveness of NST-628, an oral drug targeting the MAPK pathway, in adults with advanced solid tumors that have specific genetic mutations and have exhausted standard treatments. This Phase 1, open-label, multi-center study includes patients with tumors dependent on the MAPK pathway, such as melanoma and glioma, aiming to find a suitable dose and observe tumor responses. The study has two parts Part A involves dose escalation where increasing doses of NST-628 are given once daily in 28-day cycles to determine the maximum tolerated dose and the recommended dose for expansion. Part B involves dose expansion with several cohorts of patients harboring specific MAPK pathway mutations receiving the recommended dose to further assess safety and tumor response. Dose adjustments may be made based on observed effects. Participants will undergo regular assessments including safety evaluations, tumor response measurements using standardized criteria, and pharmacokinetic analyses throughout the study, which lasts about one year on average for primary outcomes and up to two years for survival monitoring. Tumor tissue samples are required, and patients will be followed until the last visit of the final participant. Safety, tumor response, progression-free survival, overall survival, and drug behavior in the body are key outcomes measured.

Researchers are evaluating a new form of hormone therapy called ASP5541 for men with advanced prostate cancer that has spread to other parts of the body. This phase 2 study compares ASP5541 given by injection with the standard abiraterone acetate tablets, both combined with a steroid called prednisone or prednisolone. The study aims to assess how well ASP5541 works and its safety in men who have not previously been treated with androgen receptor pathway inhibitors, including specific evaluation in Japanese men. Participants are divided into three groups based on their cancer type and treatment history. ASP5541 is given as a muscle injection every 12 weeks, while abiraterone acetate is taken as a daily tablet. Men with metastatic castration-resistant prostate cancer take prednisone or prednisolone twice daily, and men with metastatic hormone-sensitive prostate cancer take it once daily. All groups also receive standard care such as androgen deprivation therapy. Some participants will monitor blood pressure at home weekly. During the study, men visit the clinic regularly for health checks, safety monitoring, and scans to observe any changes in their cancer. The frequency and type of visits depend on each participants health and treatment stage. Researchers will measure prostate-specific antigen PSA levels, adverse events, physical exams, ECGs, and performance status to evaluate treatment effects and safety. The study may last up to about 3 years for some outcomes, with longer follow-up for certain measures.