Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Ex… (NCT07631884) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor
15 participantsStarted 2026-06-15
Plain-language summary
The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants.
The main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg/kg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female participants aged 18 years or older.
. Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced/metastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
. Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).
. Willing and able to provide adequate tumor specimens for central pathological re-testing of HER2 status. For participants previously treated with anti-HER2 therapy, tumor specimens obtained after the last anti-HER2 treatment are optional.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing trastuzumab rezetecan specifically in tumors that express HER2 — has my tumor been tested for HER2 expression, and if so, what level was found, since that would affect whether this trial might even be relevant for my situation?
2Since this is a Phase 2 trial covering many different cancer types like biliary tract, pancreatic, colorectal, and urothelial cancers, what does the available Phase 1 safety data tell us about the risks of trastuzumab rezetecan, and are there any side effects I should be especially aware of given my specific cancer type?
3The trial is listed as 'not yet recruiting' — do you have a sense of when it might open and whether waiting for this study could affect my other treatment options in the meantime?
4The main thing this trial is measuring is objective response rate, meaning whether the tumor actually shrinks — based on what you know about HER2-targeted antibody-drug conjugates like this one, what are realistic expectations for response in a cancer like mine?
5Are there standard treatments or other HER2-targeted therapies already approved for my specific cancer type that I should consider first before thinking about an exploratory trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate, ORR
Timeframe: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.
. At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
. Adequate organ and bone marrow function within 14 days prior to enrollment, meeting the following criteria:
. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.
Exclusion criteria
. Presence of any severe and/or uncontrolled diseases:
. Active hepatitis: Liver function not meeting the inclusion criteria. Hepatitis B: HBV DNA ≥ 2000 IU/mL or ≥ 10\^4 copies/mL.Hepatitis C: HCV RNA ≥ 2000 IU/mL or ≥ 10\^4 copies/mL. Participants with viral load below the above thresholds after nucleoside antiviral therapy are eligible. Chronic hepatitis B virus carriers with HBV DNA \< 10\^4 IU/mL must receive concurrent antiviral treatment throughout the study for enrollment.
. History of immunodeficiency diseases, including HIV positivity or other acquired/congenital immunodeficiency disorders.
. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
. Within 6 months prior to the first study drug administration, presence of esophageal gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.
. Unhealed or poorly healing wounds, or active ulcers.
. Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.