Adenoid Cystic Carcinoma

Researchers are evaluating zanidatamab, an intravenous drug, for treating adults with previously treated solid tumors that show high levels of HER2 protein (IHC 3+). This phase 2, open-label study focuses on participants whose tumors have progressed after prior systemic treatments and aims to assess the drug's safety and effectiveness. The study excludes certain cancers like biliary tract cancer and considers participants with various solid tumors such as breast, gastric, lung, and colorectal cancers. Participants will receive zanidatamab through intravenous infusion, with treatment details tailored to their specific tumor type and prior therapy history. The study includes cohorts with different prior treatment backgrounds, including those who have received HER2-targeted therapies and those who have not. Tumor samples will be centrally tested to confirm HER2 overexpression, and participants must have measurable disease for assessment. During the study, participants will undergo regular evaluations including imaging scans assessed by independent review and investigators to measure tumor response using RECIST 1.1 criteria. Researchers will monitor safety through adverse event reporting and laboratory tests, track drug levels and immune response, and assess quality of life related to side effects. The study duration for outcome assessment is up to 2.5 years for most measures, with overall survival followed up to 3.5 years.

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 evaluating the Integrative Medicine at Home (IM@Home) program to see if it improves patient-reported values, outcomes, and experiences for people undergoing systemic cancer treatments such as chemotherapy, immunotherapy, radiotherapy, targeted agents, or cytoreductive surgery. This program is part of the IMPROVE research initiative and focuses on patients with various cancers including head and neck, thoracic, gynecologic, melanoma, breast, and ovarian cancers. The goal is to assess how virtual mind-body therapies may support cancer patients during their treatment journey. Participants will be randomly assigned to either the IM@Home group or an enhanced usual care group. Those in the IM@Home group will take part in a 12-week virtual program offering weekly synchronous mind-body and fitness classes via Zoom, led by trained therapists with oncology expertise. Classes include activities such as fitness, yoga, dance therapy, tai chi, meditation, guided meditation, and music therapy. Each session lasts 30 to 45 minutes, with time for feedback and discussion. The enhanced usual care group will receive standard care plus access to pre-recorded meditation and relaxation resources. During the 12 weeks, participants will be monitored through patient-reported assessments measuring fatigue severity, symptom intensity, insomnia, psychological distress, pain, treatment expectancy, satisfaction, and session attendance. Researchers will also track treatment disruptions and unplanned medical visits. These evaluations will help determine the impact of the IM@Home program on patient well-being and treatment experience throughout the study period.

Researchers are studying a new combination treatment for patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma, a type of cancer that affects the sinus and nasal areas. This prospective, multicenter, single-arm phase II clinical trial aims to find out if combining Becotatug vedotin (MRG003) with epirubicin before surgery can improve the rate of tumor shrinkage enough to allow for successful surgery or better disease control. The study is sponsored by the Eye & ENT Hospital of Fudan University and involves 40 patients. Participants receive three cycles of neoadjuvant therapy given every 21 days. Each cycle includes an intravenous infusion of Becotatug vedotin at 2.0 mg/kg and epirubicin at 75 mg/m² on the first day. After completing three cycles, patients are evaluated for tumor response and potential eligibility for surgery. The study also includes a translational research part where tumor samples are used to create organoid models to test drug sensitivity. During the study, patients undergo imaging tests to measure tumor response about 21 days after the last treatment cycle. Safety and side effects are monitored from the first dose until about 30 days after the final treatment. Surgery assessments occur within four weeks after therapy completion to evaluate surgical outcomes. Patients are then followed for up to 48 months to monitor disease control, progression-free survival, and overall survival. An independent safety board reviews the trial data after the first 20 patients are enrolled to ensure participant safety.

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 enfortumab vedotin as a potential treatment for people with adenoid cystic carcinoma (ACC), a type of cancer that may be recurrent or metastatic. This phase II trial aims to assess whether this drug is effective and safe for individuals whose cancer cannot be cured by other therapies. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on patients with measurable disease and recent progression or worsening symptoms. Participants receive enfortumab vedotin intravenously on Days 1, 8, and 15 of each 28-day treatment cycle. The dosing schedule allows for a window of plus or minus three days around each administration day. This treatment continues through multiple cycles as determined by the study protocol. There are no placebo groups; all participants receive the study drug. During the trial, participants will undergo regular assessments including imaging to measure tumor response, laboratory tests to monitor health status, and documentation of any side effects. The main outcome the researchers will evaluate is the best overall response rate within one year. They will also observe progression-free survival over the same period. Participants are expected to sign informed consent and adhere to contraception requirements if applicable. Safety and treatment effects will be closely monitored throughout the study period.

Researchers are evaluating the safety, tolerability, and effectiveness of the study drug LY4050784 alone or combined with other anticancer agents in adults with locally advanced or metastatic solid tumors that have a SMARCA4 (also called BRG1) gene alteration. This study includes participants who have previously received, do not qualify for, or refuse standard treatments, or when no standard therapy exists. The trial is conducted in two parts: phase Ia for dose escalation and phase Ib for dose optimization and expansion, lasting up to about 4 years. The study involves oral administration of LY4050784 in escalating doses or fixed doses, either alone or combined with intravenous anticancer drugs such as pembrolizumab, pemetrexed, cisplatin, carboplatin, paclitaxel, or nab-paclitaxel. Treatments are given in 21-day cycles, and participants may continue until specific discontinuation criteria are met. Different groups receive either LY4050784 alone or in combination with these agents, with careful dose evaluation during phase Ia and expansion in phase Ib. Participants will undergo regular assessments to monitor safety, including tracking any adverse events and determining the maximum tolerated dose. Researchers will measure how the drug is processed in the body, antitumor activity through response rates and disease control, and overall treatment effects over up to 4 years. Evaluations include physical exams, imaging scans, laboratory tests, and performance status checks. The study also monitors tolerability and long-term effects during treatment and follow-up periods.

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 type—GIST, small-cell lung cancer (SCLC), and other c-Kit positive tumors—to 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.

Researchers are evaluating the drug XMT-1660 in people with solid tumors that are recurrent, advanced, or have spread (metastatic). This first-in-human study aims to test the safety, side effects, and potential effectiveness of XMT-1660 in treating various solid tumors including breast, ovarian, endometrial, and other cancers. The study has two parts: Dose Escalation to determine the safe dosage, and Dose Expansion to further study safety and treatment response. Participants receive XMT-1660 through a vein in the arm or port catheter (intravenously) as a single-agent treatment. The Dose Escalation phase identifies the appropriate dose, while the Dose Expansion phase uses that dose to assess safety and tumor response. The study does not use placebo or comparison groups; all participants receive XMT-1660 alone. During the study, participants undergo regular monitoring for side effects and treatment response, including imaging and tumor assessments based on RECIST criteria. Brain MRI is required for certain participants before treatment. Researchers measure adverse events, tumor response rates, drug concentration in the blood, and immune responses against the drug. The study continues with follow-up assessments for up to approximately three years to evaluate safety and effectiveness.

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.