A Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HH-101 in Patients With Advanced Solid Tumors

An Open-Label Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HH-101 as Monotherapy in Patients With Advanced Solid Tumors

The goal of this study is to evaluate the safety of HH-101 antibody, administered as monotherapy to participants with advanced solid tumors.

Inclusion Criteria:

• Voluntary signing of the written informed consent form;
• Histologic or cytologic confirmation of advanced solid tumor;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Have an estimated life expectancy ≥3 Months, in the judgement of the investigator;
• Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Exclusion Criteria:

• History of other malignancies within 5 years prior to the first dose of study drug, except for malignancies that have been cured after treatment, such as thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the breast.
• Receipt of the last systemic anti-tumor therapy within 2 weeks prior to the first dose of study drug, including chemotherapy, radiotherapy, targeted therapy, or traditional Chinese herbal medicine or patent Chinese medicines with anti-tumor activity. Patients who received tumor immune checkpoint inhibitor therapy within 4 weeks prior to the first dose of study drug.
• Adverse reactions from previous treatments that have not recovered to CTCAE v5.0 Grade 1 or lower (except for alopecia and neuropathy, which, in the Investigator's judgment, are long-standing and not expected to recover).
• Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
• If female, is pregnant, breastfeeding, or planning to become pregnant.
• Known hypersensitivity to HH-101 Injection or any of its components. History of severe hypersensitivity reactions to other therapeutic antibody drugs. Known allergy to multiple substances or history of severe allergic diseases.
• Known interstitial lung disease or non-infectious pneumonitis requiring steroid therapy.
• Other severe, acute, or chronic medical conditions, psychiatric disorders, or laboratory abnormalities that, in the Investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results.