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Showing 1-20 of 21 trials
NCT06764875
This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.
NCT06532006
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
NCT06328738
The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab, and chemotherapy in participants with advanced-stage HER2-positive colorectal cancer and breast cancer.
NCT06414733
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.
NCT06846996
Trastuzumab deruxtecan's (T-DXd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among Chinese patients. The objective of this study is to evaluate real-world effectiveness and safety profile of T-DXd by collecting real-world data treating in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
NCT05586061
This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Disitamab Vedotin in Combination With Tirelizumab and S-1 as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.
NCT06730373
This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.
NCT05555251
HER2+ breast and gastric cancer patients' survival is significantly improved by trastuzumab alone or in combination with chemotherapy. However, many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607, a human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) targets CD32b (Fc Gamma Receptor IIB), it is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. This is a Phase 1/2a, first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors whose tumor has progressed after standard therapy.
NCT05715931
This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive locally advanced gastric or esophagogastric junction adenocarcinoma.
NCT06572319
This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors
NCT06253650
TRINITY is designed as a multicentre, randomized, open-label, interventional phase II study aimed at investigating the activity, efficacy and safety of trastuzumab-deruxtecan (T-DXd) plus capecitabine/5-fluorouracil as a post-operative treatment in localized/locally advanced gastric or gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma patients with HER2 overexpression/amplification and positive post-operative ctDNA after pre-operative 5-fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) regimen followed by radical surgery.
NCT06439550
This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab，Trastuzumab and SOX in the adjuvant treatment of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC)
NCT03330561
A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.
NCT05982834
At present, there is no anti-HER2 therapy recommended by guidelines for second-line treatment of advanced gastric cancer with HER2-positive or HER2-overexpression, and combined with anti-angiogenic drugs are mainly used. Disitamab Vedotin is an anti-HER2 ADC, and its cytotoxic drugs are also anti-microtubule formation as the main mechanism of drugs. Fruquintinib is an anti-vascular TKI drug. In addition, according to the results of KEYNOTE-811, patients with HER2-positive advanced gastric cancer benefit significantly from immunotherapy, so the investigators hope to explore the possibility of immunotherapy in second-line treatment of HER2-positive advanced gastric cancer. Therefore, the study plans to enroll HER2-positive patients who have failed first-line therapy and explore the efficacy of the regimen of Disitamab Vedotin combined with fruquintinib combined with Tislezumab in second-line therapy.
NCT05955833
The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a PET-scan. For this research, the investigators make PET-scans in people with HER2-positive, metastasized breast- or gastric cancer. The investigators will investigate if the new HER2-tracer correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain HER2-directed therapies. Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 60 minutes. The PET-scans are on separate days within a week after injection of the tracer (e.g. 1 day, 2 days and 4 days after injection). Furthermore, the investigators will take 7 blood samples (5 mL each). Participants are not required to stay at the hospital. The first 3 participants will undergo an extra PET-scan 1 - 2 hours after injection. The amount of radioactivity injected will be 37 MBq (± 10%).
NCT05619016
The goal of this phase II clinical trial is to improve the selection of patients with solid tumors who would benefit from effective treatment with HER2 targeted drugs. This will be achieved by examining patients with HER2 positive tumors in the esophagus or stomach or patients with advanced breast cancer with low HER2 expression (HER2low) with the HER2 specific positron emission tomography (PET) tracer ABY-025 (HER2-PET) and compare the imaging results with HER2 expression in tumor tissue derived from biopsies (reference standard).
NCT05190445
A Phase 2, multi-center, open-label study of cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel in patients with HER2-high and in combination with tucatanib in patients with HER2-low gastric or gastroesophageal junction (GEJ) adenocarcinoma.
NCT05313906
To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.
NCT05270889
Study Design: This is a Phase II study to assess the safety and clinical efficacy of this combined chemotherapy-free regimen (zanidatamab and tislelizumab) in HER2-positive advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma after first line treatment. The study will be conducted as phase II study to evaluate the safety and tolerability of the combination treatment of zanidatamab and tislelizumab and determine anti-tumor activity in HER2-positive advanced gastric/GEJ adenocarcinoma patients. This study will be conducted at up to 6 medical centers in Korea. Patients who are HER2-positive will be confirmed by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH)/silver in situ hybridization (SISH) at local laboratory. Patients who meet all eligibility criteria will be enrolled to this study and receive treatment with zanidatamab and tislelizumab until progressive disease is confirmed or at least 1 discontinuation criterion is met. Study Assessments: Patients will be monitored for safety, tolerability, and antitumor activity throughout the study. Safety will be assessed throughout the study by monitoring AEs/SAEs, and laboratory results. Vital signs, physical examinations, Eastern Cooperative Oncology Group (ECOG) performance status change, ECG results, echocardiogram/MUGA, and other examinations will also be used for safety assessment. Anticancer activity will be evaluated by the investigator using RECIST 1.1. Radiological assessment of tumor response status will be performed every 6 weeks (±7 days) from (anchored to) Cycle 1 Day 1 for the first 54 weeks and every 12 weeks (±7 days) thereafter until disease progression, withdrawal of consent, death, or start of a new anticancer therapy. Patients who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original plan until the patient begins a subsequent anticancer treatment, experiences disease progression, withdraws consent, is lost to follow up, death, or until the study terminates, whichever occurs first. Duration of Patient Participation: Screening Period is within 28 days prior to the first dose of study drug. Treatment Period starts with the first dose administration of study drug and ends when the patient is discontinued for study treatment when they are no longer considered to be achieving clinical benefit due to confirmed disease progression or unacceptable toxicity, or due to death or withdrawal of consent. Safety Follow-up. Patients who discontinue treatment for any reason will be asked to return to the clinic for the Safety Follow up Visit (to occur approximately 30 days (±7 days\] after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first). In addition, telephone contacts with patients treated with zanidatamab and tislelizumab should be conducted to assess immune-mediated AEs and concomitant medications (if applicable, i.e. associated with an immune-mediated AE or is a new anticancer therapy) at 60 (±14 days) and 90 days (±14 days) after the last dose of study drug(s) regardless of whether the patient starts a new anticancer therapy. Survival Follow-up. Patients will be followed for survival and further anticancer therapy information after discontinuation of study treatment via telephone calls, patient medical records, and/or clinic visits approximately every 3 months (±14 days) after the Safety Follow-up Visit or as directed by the investigator until death, loss to follow-up, withdrawal of consent, or study completion.
NCT04464967
The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the preliminary efficacy for each combination regimen.