Adenoid Cystic Carcinoma

Researchers are evaluating zanidatamab for treating adults with previously treated solid tumors that overexpress the HER2 protein at a high level IHC 3. This Phase 2 study focuses on participants whose tumors have progressed after at least one prior systemic treatment and who have no other confirmed beneficial treatment options. The study excludes certain cancers like biliary tract cancer and considers prior HER2 therapy differently across tumor cohorts. Participants receive zanidatamab through intravenous infusion. The study includes a single treatment group with no placebo comparison. Treatment continues as per protocol with monitoring for responses and safety. The study collects tumor samples centrally to confirm HER2 status and requires measurable disease for evaluation. Various cohorts have specific prior treatment requirements. During the study, participants undergo assessments including tumor response evaluation by independent review and investigators using standard criteria RECIST 1.1. The trial monitors treatment safety, side effects, drug levels in the blood, and immune reactions to the drug. Participants will be followed for up to 2.5 years for response and safety, and overall survival is tracked for up to 3.5 years, with regular visits to assess health status and treatment effects.

Researchers are evaluating the safety and effectiveness of Ivonescimab, an antibody treatment, in adults with advanced, metastatic salivary gland cancers that cannot be cured. This phase 2, open-label study focuses on participants with recurrent or metastatic salivary gland carcinomas, including adenoid cystic carcinoma. Ivonescimab is not yet approved by the FDA for this cancer but has been used for lung cancer treatment. The study is supported by Summit Therapeutics and led by Glenn J. Hanna. Participants receive Ivonescimab through intravenous infusion once daily on day 1 of each 21-day cycle. The study involves two cohorts one with adenoid cystic carcinoma and one with other salivary gland carcinomas. About 11 participants will enroll in each cohort initially if more than two respond to treatment, enrollment continues. Imaging tests occur every 9 weeks, followed by an end-of-treatment visit and imaging. After treatment ends, participants have follow-up visits every 12 weeks. During the study, participants undergo screening, clinic visits, imaging tests such as X-rays, CT, MRI, or PET scans, blood and urine tests, and tumor biopsies. Researchers will measure the objective response rate over up to 2 years and monitor progression-free survival, overall survival, duration of response, safety, and toxicity. The total participation time is approximately 3 years, including follow-up after treatment completion to observe long-term outcomes.

Researchers are studying whether a virtual mind-body program called Integrative Medicine at Home IMHome can improve how people with various types of cancer feel and experience treatment. This research focuses on patients undergoing systemic cancer treatments such as chemotherapy, immunotherapy, radiotherapy, targeted therapies, or surgery. The goal is to assess patient-reported outcomes, values, and experiences during these treatments. Participants are randomly assigned to one of two groups. One group takes part in a 12-week virtual mind-body and fitness program via Zoom, choosing from weekly classes like yoga, dance therapy, tai chi, meditation, or music therapy led by specialized therapists. Each class lasts 30 to 45 minutes. The other group receives enhanced usual care, including a handout and access to on-demand meditation and relaxation recordings online. During the study, participants will be monitored for 12 weeks. Researchers will evaluate fatigue severity, symptom intensity, insomnia, psychological distress, pain, treatment expectations, satisfaction with the intervention, and healthcare usage such as treatment disruptions and unplanned medical visits. Attendance to the IMHome sessions will also be tracked. This comprehensive approach aims to understand how the program may affect patients well-being while undergoing cancer treatment.

Researchers are evaluating the combined use of Becotatug vedotin MRG003 and epirubicin as a neoadjuvant therapy for patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma SNACC. This prospective, multicenter, single-arm, open-label phase II study aims to determine if this combination can achieve a sufficient objective response rate to allow for radical surgery or better disease control. The study also includes a translational research component to analyze tumor biopsies and correlate drug sensitivity with clinical outcomes. Participants receive MRG003 at 2.0 mgkg intravenously and epirubicin at 75 mgm intravenously on day 1 of each 21-day cycle for a total of 3 cycles. The primary outcome is the objective response rate assessed about 21 days after the third cycle. Secondary outcomes include safety, surgical conversion rate, disease control, progression-free and overall survival, and pathological response. Tumor biopsies are used to develop patient-derived organoid models for drug sensitivity testing. During the study, participants undergo assessments of tumor response, safety monitoring up to 30 days after the last dose, and surgical evaluation within 4 weeks after neoadjuvant therapy. Long-term follow-up includes monitoring progression-free and overall survival every 3 months for 2 years, then every 6 months up to 5 years. The total study duration is approximately 48 months, including enrollment, treatment, and follow-up. An independent board reviews safety after 20 participants enroll.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating a drug called Emi-Le Emiltatug Ledadotin in participants with various solid tumors, including recurrent, advanced, or metastatic cancers such as breast, endometrial, ovarian, fallopian tube, primary peritoneal cavity cancers, and adenoid cystic carcinoma. This first-in-human study aims to test the safety, side effects, and anti-tumor activity of Emi-Le. The trial includes dose-finding, safety, and effectiveness phases to better understand Emi-Les role in treating these cancers. The study has three parts Dose Escalation, Dose Expansion, and a Phase 2 part called EMBLEM-1. In Dose Escalation, researchers determine the appropriate dose of Emi-Le. Then, Dose Expansion uses that dose to further assess safety and response in solid tumors. In EMBLEM-1, the focus is on evaluating Emi-Les effect on aggressive Adenoid Cystic Carcinoma and continuing safety monitoring. Emi-Le is given intravenously through a vein or port catheter. Participants will undergo screenings including tumor tissue collection for testing and brain MRI if indicated. During treatment, researchers will monitor adverse events, tumor response, survival, and other health measures over up to approximately three years. The main outcomes include frequency of dose-limiting toxicities, overall response rate, and safety. The study involves regular assessments to track Emi-Les impact and participants well-being throughout the trial.

Researchers are evaluating enfortumab vedotin as a treatment for people with adenoid cystic carcinoma ACC, a rare cancer. This Phase II study aims to find out if enfortumab vedotin is effective and safe for patients with recurrent or metastatic ACC who have limited treatment options. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on measuring the best overall response rate within one year. Participants receive enfortumab vedotin intravenously on Days 1, 8, and 15 of a 28-day cycle, following the FDA-approved dosing schedule. The dose can be administered up to three days before or after the scheduled day. The treatment continues in cycles, and patients are closely monitored throughout. During the study, participants undergo regular assessments including imaging to measure tumor response and progression. Researchers monitor treatment effects, side effects, and progression-free survival over one year. Laboratory tests and physical exams are conducted to ensure patient safety. Participants are involved for the duration necessary to evaluate outcomes, with follow-up planned through March 2027.

Researchers are studying LY4050784, a drug being tested for safety, tolerability, and effectiveness in people with locally advanced or metastatic solid tumors that have a specific genetic alteration called SMARCA4 also known as BRG1. This study includes participants who have previously received, do not qualify for, or refuse standard treatments, or when no standard therapy is available. The trial is divided into two parts phase Ia, which focuses on finding the right dose, and phase Ib, which optimizes and expands the dose. The study may last up to about four years. Participants receive LY4050784 orally in different doses and combinations. Some receive LY4050784 alone, while others receive it combined with other anticancer drugs such as pembrolizumab, pemetrexed, cisplatin, carboplatin, paclitaxel, or nab-paclitaxel. The combinations are given in 21-day treatment cycles, continuing until certain criteria are met. The study includes evaluation of escalating doses and comparison of multiple doses during the dose-escalation and dose-expansion phases. During the trial, participants are monitored for side effects, how well they tolerate the treatment, and the drugs impact on their tumors. Researchers measure treatment-emergent adverse events, serious adverse events, and antitumor activity including response rates. They assess drug levels in the blood and how the body processes the drug. Regular safety and efficacy evaluations occur throughout the study, which may last up to approximately four years from the start. Participants overall health and tumor response are tracked closely during this time.

Researchers are evaluating the safety and tolerability of NN3201, a c-Kit targeting antibody-drug conjugate, in adults with advanced or metastatic solid tumors that express c-Kit. This includes cancers such as gastrointestinal stromal tumor GIST, adenoid cystic carcinoma, uveal melanoma, neuroendocrine tumors, and certain types of renal cell carcinoma. The study is an open-label Phase 1 trial designed to identify the safest dose and assess how well patients tolerate the treatment. The study is divided into two parts a dose escalation phase Part A and an expansion phase Part B. In Part A, NN3201 is given intravenously every three weeks to patients with GIST or other c-Kit tumor types at increasing doses to determine the maximum tolerated dose. Once the optimal dose is established, Part B will enroll patients into three groups based on their cancer typeGIST, small-cell lung cancer SCLC, and other c-Kit positive tumorsto further evaluate safety and early signs of effectiveness, with treatment continuing every three weeks at one or two recommended dose levels. Participants will undergo regular assessments including monitoring for side effects, laboratory tests to check organ function, heart scans, and evaluations of tumor response. Researchers will closely track adverse events and dose-limiting toxicities during the study. The primary outcomes include safety measures such as the number of patients experiencing dose-limiting toxicities within three weeks and adverse events over one year. The study may last up to several years to gather pharmacokinetic data and assess anti-tumor activity, with participant involvement spanning the treatment and follow-up periods as defined by the protocol.

Adenoid cystic carcinoma is a rare type of tumor found in the head and neck region. Because these tumors grow slowly but have a high risk of spreading, additional radiation treatment is often needed. This study, called ACCO, is a phase II, open-label trial led by Heidelberg University Hospital, focused on using only carbon ion radiation for this tumor type. The goal is to see if carbon ion therapy alone can improve local tumor control rates from 60% to 70% over five years. The study compares two radiation approaches one group receives only carbon ion irradiation in 22 sessions over about 4 weeks, while the other group receives a combination of photon intensity-modulated radiation therapy IMRT and a carbon ion boost. This shorter schedule of carbon ion therapy is being evaluated for its effectiveness. Patients will be followed for five years after starting treatment to assess outcomes. Participants will undergo regular assessments including monitoring for tumor progression, survival, side effects during and after treatment, and quality of life. The primary measure is freedom from tumor progression in the treated area after five years. Secondary measures include progression-free survival, overall survival at 3 and 5 years, and both acute and late treatment-related toxicities. The study aims to enroll 175 patients and will closely track their health throughout the follow-up period.