A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors

An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors

This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and preliminary antitumor activity of HH160 alone or in combination with antitumor agents in participants with advanced or solid tumors, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal cancer (CRC), gastroesophageal adenocarcinoma (GEA), head and neck squamous cell carcinoma, renal cell carcinoma (RCC), endometrial carcinoma, cervical cancer, ovarian cancer, small cell lung cancer, triple-negative breast cancer, urothelial carcinoma, and additional tumor types based on emerging clinical data.

The study will also identify the recommended phase 1 dose (RP2D) of HH160 monotherapy and/or in combination with other chemotherapy regimens.

Key Inclusion Criteria

1. Adults aged 18 to 75 years with signed informed consent.
2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.
3. At least 1 measurable lesion per RECIST v1.1.
4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.
5. Adequate organ function based on protocol-specified laboratory criteria.

Key Exclusion Criteria

1. Active leptomeningeal disease or uncontrolled/untreated brain metastases.
2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.
3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.
4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage/hemoptysis.

NOTE: Other eligibility criteria may apply.