Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer

Launched by EASTERN HEPATOBILIARY SURGERY HOSPITAL · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for adults with advanced biliary tract cancer that is positive for HER2, a specific protein that can encourage cancer growth. The study will look at how well a medication called inetetamab works when combined with chemotherapy, and possibly with additional immunotherapy, as a first step in treatment. The goal is to find out if this combination can improve outcomes and provide helpful information for future treatments.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with HER2-positive metastatic biliary tract cancer. They should not have received any prior anti-HER2 treatments or systemic cancer therapies for their current disease. Participants will need to have a good overall health status and be willing to follow the study guidelines. This trial is currently not recruiting, but once it starts, participants can expect regular check-ups and monitoring to assess their health and the effectiveness of the treatment. It's also important to know that there are specific criteria that could exclude someone from joining, such as having certain medical conditions or being pregnant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males or females aged ≥18 years;
• • Histologically confirmed HER2-positive metastatic biliary tract cancer;
• • ECOG performance status of 0 to 1;
• • No prior treatment with anti-HER2 therapies;
• • Patients have not received any systemic anticancer treatment in the recurrent/metastatic setting;
• • Patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and/or radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy;
• • Presence of at least one measurable lesion;
• • Adequate function of major organs as defined by the following criteria;
• • Estimated survival of ≥3 months;
• • Voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.
• Exclusion Criteria:
• • Known allergy or contraindication to any component of the study drugs;
• • Previous treatment with anti-HER2 therapies;
• • Prior use of immunotherapy;
• * Use of immunosuppressive agents within 14 days before the first dose, except:
• • Intranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg/day prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)
• • Known active central nervous system metastases or carcinomatous meningitis;
• • Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;
• • Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;
• • Severe cardiac disease;
• • Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;
• • Neuropathy ≥ Grade I per NCI criteria;
• • Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;
• • History of immunodeficiency;
• • Participation in another drug trial within 4 weeks before screening;
• • Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;
• • Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.