HP007 Monotherapy for Relapsed or Refractory Advanced Solid Tumors

Inclusion criteria

• Male/female, 18-75 years inclusive.
• Histologically-confirmed unresectable advanced tumors (breast cancer, HNSCC, cutaneous melanoma, prostate cancer, HCC, etc.);
• no effective standard therapy or disease relapse/metastasis post-standard-of-care.
• ECOG PS 0-1;
• expected survival ≥3 months.
• At least 1 measurable lesion by RECIST 1.1. Lesion in prior radiation field must have confirmed progression ≥4 weeks post-radiation. Prostate cancer subjects must meet PCWG3 progression criteria.
• At least one lesion suitable for repeated intratumoral injection.
• Adequate hematopoietic and organ function:
• Males and females of child-bearing potential agree effective contraception from ICF signature to 3 months after last dose.
• Voluntarily sign ICF and comply with study procedures.

Exclusion criteria

• Past/current medical conditions

• CNS or leptomeningeal metastasis.
• Residual toxicity from prior anti-tumor therapy >Grade 1 (CTCAE 6.0), except alopecia and Grade 2 peripheral neuropathy without safety risk.
• Poorly controlled pleural / ascitic / pericardial effusion requiring local intervention or repeated drainage.
• Active autoimmune disease or high-risk history of recurrence; organ transplant with immunosuppression.
• Interstitial lung disease / non-infectious pneumonitis; pulmonary embolism within prior 12 weeks.
• Severe cardio-cerebrovascular events within 6 months; QTcF ≥470 msec; LVEF ≤50%; NYHA ≥III heart failure; history of long-QT syndrome or ongoing QTc-prolonging drugs.
• Uncontrolled hypertension (SBP>160 mmHg and/or DBP>100 mmHg) or other uncontrolled systemic diseases.
• High bleeding risk / coagulation disorders: inherited/acquired bleeding-thrombotic predisposition; major bleeding within 3 months; thrombolytics within 10 days; ongoing anticoagulant/antiplatelet therapy (except heparin for CVC patency).
• Immunodeficiency; history of solid-organ or hematopoietic stem-cell transplantation.
• Active TB within past 5 years.
• Severe infection / trauma / GI perforation / fistula / tumor vascular invasion / bowel obstruction within 4 weeks; active infection or antibiotic use within prior 2 weeks (prophylaxis allowed); unexplained fever >38.5 ℃ (tumor-related fever may be allowed per Investigator judgment).
• Other active malignancy within 3 years, except: cervical carcinoma in-situ, local basal-cell carcinoma, or malignancies cured ≥5 years without recurrence.
• Prior medications & treatments

• Local radiotherapy completed <1 week before first dose; >30% bone-marrow / extensive-field radiotherapy completed <4 weeks before first dose.
• Anti-tumor therapy within 4 weeks or less than 5 half-lives (whichever shorter).
• Systemic corticosteroids (>10 mg prednisone equivalent/day) or other immunosuppressants within 14 days.
• Prior immunotherapy with irAEs ≥Grade 3.
• Prior systemic TLR-agonist treatment (topical TLR agonists e.g. imiquimod permitted).
• Vaccination within 1 month prior to enrolment.
• Allergy, general status & others

• Severe hypersensitivity (CTCAE 6.0 ≥Grade 3) to any investigational product component.
• Active HBV / HCV, positive syphilis or HIV serology.
• Participated in another interventional clinical trial within 4 weeks.
• Major surgery within 4 weeks before screening or planned major surgery during study.
• Alcohol / illicit-drug / substance abuse within 12 months.
• Documented neurological/psychiatric disorders leading to poor compliance.
• Pregnant or lactating females.
• Subjects judged unsuitable by the Investigator for any other reason.