Intratumoral H101 with immune checkpoint inhibitors for advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, open-label observational study will enroll 10-15 adults with metastatic breast cancer that progressed after prior therapies. Participants will receive intratumoral H101 injections on day 1 of 2-3 week cycles, followed by an immune checkpoint inhibitor starting about a week later, for a total of four cycles. The study will monitor antitumor activity, safety, and changes in the tumor immune microenvironment, with tumor biopsies and blood samples collected before and after treatment when feasible. Treatment decisions are guided by the treating physician within a standardized observational framework, without altering standard clinical care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 75 years, both genders;
* Pathologically confirmed breast cancer (Stage IV)；
* Disease progression after at least one line of standard systemic therapy；
* ECOG performance status 0-2；
* Intolerant to or refusal of standard chemotherapy；
* At least one radiologically measurable lesion per RECIST 1.1 criteria；
* At least one lesion amenable to puncture/injection (i.e., accessible for intratumoral injection)；
* Estimated life expectancy ≥3 months；
* Adequate major organ function as defined by the following laboratory values:Absolute neutrophil count (ANC) ≥1.5×10⁹/L,Platelet count (PLT) ≥100×10⁹/L,Hemoglobin (Hb) ≥90 g/L,Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN),Serum creatinine (Cr) ≤1.5× ULN；
* Signed informed consent form；
* Agreement to provide tumor tissue samples and peripheral blood samples before and after treatment for research purposes.。

Exclusion Criteria:

* Known allergy to H101 formulation, PD-1 inhibitors, or any of their excipients ;
* Lymphocyte count \<0.5×10⁹/L;
* Severe infection, active infection (particularly HBV, HCV, HIV), or severely immunocompromised status;
* Presence of lesions that cannot be safely punctured/injected;
* Prior treatment with PD-1/PD-L1 inhibitors with grade ≥3 immune-related adverse events that have not resolved;
* Concurrent active malignancy other than breast cancer (except for those cured for \>5 years with no evidence of recurrence);
* Uncontrolled brain metastases;
* Pregnant or breastfeeding wome;
* Psychiatric disorders, cognitive impairment, or poor compliance that may interfere with study participation and completion;
* Severe cardiac, hepatic, or renal failure;
* Long-term immunosuppressive therapy;
* Uncontrolled active autoimmune disease.

Where it's running

• Foshan Fosun Chancheng Hospital
  Guangdong, Foshan, China Recruiting

Study contacts

• Study coordinator: Jie Yuan, Doctoral degree
• Email: candlewjy@163.com
• Phone: +86 13016007353

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.