Spokane

Researchers are investigating new treatments for high-risk, early-stage breast cancers that are either triple-negative or hormone receptor-low positive and HER2-negative. These types of breast cancer have limited amounts of certain proteins that affect growth, making them challenging to treat. This Phase 3 trial aims to compare the effects of adding sacituzumab tirumotecan, a targeted therapy, to pembrolizumab and chemotherapy against pembrolizumab with chemotherapy alone in controlling cancer growth and spread. Participants are randomly assigned to one of two treatment groups. One group receives sacituzumab tirumotecan intravenously every two weeks along with pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab combined with carboplatin and paclitaxel for another 12 weeks. After this, surgery and optional radiation therapy occur, followed by pembrolizumab infusions for up to about 28 weeks. Additional treatments such as olaparib, capecitabine, or doxorubicin with cyclophosphamide may be given if cancer remains. The other group receives chemotherapy drugs carboplatin, paclitaxel, cyclophosphamide, and doxorubicin or epirubicin alongside pembrolizumab during similar time frames, followed by surgery, radiation, and pembrolizumab maintenance with possible additional treatments. Throughout the study, participants undergo assessments including surgery to remove tumors, imaging, and laboratory tests. Researchers measure cancer cell presence after surgery and monitor how long participants live without cancer progression or recurrence, as well as overall survival. Quality of life and side effects are tracked using questionnaires over several years. Safety is monitored by recording adverse events and treatment discontinuations. The study may last up to around 115 months for long-term follow-up.

Researchers are evaluating ALD-102 Solution in adults with alopecia areata to determine its safety, tolerability, and effect on hair regrowth. This first-in-human clinical trial compares ALD-102 injections in the scalp to placebo injections and untreated areas. The study aims to understand treatment-related side effects and hair regrowth outcomes in affected scalp areas. Participants receive injections of ALD-102 Solution or placebo once every 4 weeks over an 8-week treatment period. Different scalp areas are selected for treatment, placebo, or no treatment depending on the cohort. The study includes multiple injections per treatment area, with dosing adjusted by cohort. This randomized, triple-blind study monitors participants for adverse effects and drug levels. Throughout the trial, participants undergo clinical assessments, local tolerability evaluations, and safety monitoring for 24 weeks. Skin biopsies and blood samples are collected to measure ALD-102 concentrations. Researchers track hair regrowth and adverse events using standardized scales and assessments. Participants are required to follow study procedures and maintain consistent hair styling during the study duration.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or Latino/Latina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects like weight gain, fatigue, and reduced physical fitness after cancer treatment. The study aims to see if this culturally-relevant program can help increase physical activity and improve overall health compared to using a Fitbit tracker alone. The study has two stages. In Stage 1, 20 Latinx survivors participate in developing the intervention using Fitbit trackers, text messages, social media support, wearable activity devices, and interviews over 9 months. In Stage 2, 170 survivors who do not meet physical activity guidelines are randomized to either the intervention group, which includes Fitbit use, weekly goal-setting, peer support via social media and Zoom meetings, and optional activity partners, or a control group that only uses Fitbit trackers for 12 weeks. The intervention includes an intensive phase with weekly sessions followed by a 4-week maintenance phase. Participants will wear Fitbit trackers daily and engage in goal-setting, peer discussions, and physical activity reminders. Researchers will measure moderate to vigorous physical activity, sedentary time, and health-related quality of life over 12 weeks. Additional evaluations include physiological markers of heart and metabolic health and qualitative interviews to improve the program. The study lasts through the intervention phases with ongoing monitoring and support for participants.

Researchers are evaluating ALX2004, an antibody drug conjugate targeting EGFR, in adults with advanced or metastatic selected solid tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer. This Phase 1, open-label, multicenter study aims to find the appropriate dose and assess safety and response in participants who have previously received treatment for these cancers. The study is sponsored by ALX Oncology Inc. and plans to enroll up to 170 patients. The study includes three parts: Phase 1a Dose Escalation with increasing doses of ALX2004 to find a safe dose, Phase 1a Dose Exploration where selected doses are further tested in specific tumor types, and Phase 1b Dose Expansion where the recommended dose is given to more patients. ALX2004 is given by intravenous infusion, and dosing is adjusted depending on the study phase and tumor type. Participants will have regular assessments including safety monitoring for dose limiting toxicities and adverse events, tumor response evaluations using RECIST criteria, and measurement of drug levels in the blood. Follow-up can last up to two years from the first dose. The study records outcomes like overall response rate, progression-free survival, and overall survival to understand ALX2004's effects. The total duration of participation depends on the treatment phase and follow-up period.

Researchers are evaluating the effectiveness and safety of two treatments, rilvegostomig and pembrolizumab, each combined with platinum-based doublet chemotherapy, as first-line therapy for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. The study is a Phase III, randomized, double-blind trial conducted globally at multiple centers. It focuses on patients with tumors expressing PD-L1 at 1% or higher and aims to compare these treatment combinations in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group receives rilvegostomig intravenously on Day 1 of each 21-day cycle, combined with platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed, followed by maintenance rilvegostomig plus pemetrexed monotherapy. The other group receives pembrolizumab intravenously on the same schedule with the same chemotherapy drugs, followed by pembrolizumab plus pemetrexed maintenance. Chemotherapy is given for up to four cycles. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately five years. Researchers will also assess response rates, duration of response, pharmacokinetics, immunogenicity, and patient-reported physical function and quality of life. Safety will be carefully tracked throughout the study. The trial began in late 2024 and is expected to conclude around March 2030.

Researchers are evaluating the efficacy and safety of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with the same chemotherapy for first-line treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) at 1% or higher. This Phase III, randomized, double-blind, global study focuses on patients with squamous mNSCLC without actionable genomic mutations and assesses these treatments over approximately five years. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle, combined with carboplatin and paclitaxel or nab-paclitaxel chemotherapy. Chemotherapy is given up to 4 cycles, with nab-paclitaxel administered on Days 1, 8, and 15 of each cycle. After chemotherapy, patients continue with the assigned immunotherapy drug. The study compares these two treatment regimens as first-line therapy. During the study, participants undergo regular assessments including imaging to measure tumor response, survival, and disease progression up to about five years. Researchers also monitor physical functioning, quality of life, lung cancer symptoms, and drug pharmacokinetics and immunogenicity. Safety is closely followed, and overall survival and progression-free survival are the primary outcomes measured to evaluate the treatments' impact.

Researchers are evaluating the effectiveness and safety of volrustomig compared to observation in adults with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). This phase III global study focuses on patients with specific stages of LA-HNSCC and aims to better understand treatment options after initial therapy. Participants are randomly assigned to one of two groups: one group receives volrustomig, a drug being studied, while the other group is placed under observation without additional treatment. The study is open-label and conducted at multiple centers worldwide. The treatment or observation period follows the completion of definitive cCRT with curative intent. During the study, participants undergo regular assessments to monitor progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also track the presence of anti-drug antibodies and measure drug concentrations in blood samples. Safety is monitored by recording adverse events over a period of up to approximately 8 years, allowing long-term evaluation of outcomes and participant well-being.

This research aims to assess the long-term safety and tolerability of JNJ-81201887, a medicine given by injection into the eye, in people with geographic atrophy secondary to age-related macular degeneration. The study includes participants who were previously treated in earlier clinical studies of this medicine. The main goal is to monitor any eye or systemic side effects and abnormal findings over up to five years. Participants who received low or high doses of JNJ-81201887 in earlier studies, as well as those initially given a sham procedure who may have later received the medicine, will join this extension study. No new treatments or injections will be given during this long-term study. It is designed as a randomized, triple-masked phase 2 trial to carefully observe participants over time. During the study, participants will have regular eye examinations, retinal imaging, and laboratory tests to check for any changes or adverse events related to the earlier treatment. Researchers will track ocular and systemic treatment-emergent adverse events for up to five years. Participants will be involved throughout this period with scheduled visits to monitor their condition and safety status consistently.

Researchers are evaluating CTX-8371 in a Phase 1, open-label study involving patients with advanced cancers that are metastatic or locally advanced and have not responded to standard treatments. The study aims to assess the safety, tolerability, immune response, and how the body processes CTX-8371, as well as its preliminary anti-tumor effects. The research is organized into two groups: Dose Escalation and Dose Expansion cohorts. In the Dose Escalation group, patients receive increasing doses of CTX-8371 through intravenous infusions every two weeks, with doses ranging from 0.1 to 10.0 mg/kg. The Dose Expansion group receives fixed doses of either 3.0 mg/kg or 10.0 mg/kg, also administered intravenously every two weeks. Different tumor types such as non-small cell lung cancer, triple-negative breast cancer, and Hodgkin lymphoma are included in the Dose Expansion group. Participants will undergo regular safety and response evaluations including blood tests, imaging, and physical exams over an average follow-up of six months to two years depending on cohort. Researchers monitor tumor response, survival, and how the drug is processed in the body. Safety is tracked from the first dose until 30 days after the last dose. Participants will be closely followed for side effects, immune response, and treatment effects throughout the study period.

Researchers are studying DB-1311/BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 1/2a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311/BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavir/ritonavir and itraconazole. Participants receive intravenous doses of DB-1311/BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311/BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drug’s safety and preliminary antitumor activity. Participants' health and cancer are closely followed throughout and after treatment.