Testing HS-20089 for advanced solid tumors

A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20089 in Patients With Advanced Solid Tumors

This study is testing a new drug called HS-20089 to see if it can help people with advanced solid tumors that have a specific marker called B7-H4.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 177 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hansoh BioMedical R&D Company (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05263479 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial evaluates HS-20089, a novel antibody-drug conjugate targeting B7-H4, in patients with advanced solid tumors. The study is designed as an open-label, multicenter trial with dose escalation and expansion cohorts to determine the maximum tolerated dose and assess safety, pharmacokinetics, and preliminary anti-tumor activity. Patients will be enrolled based on specific tumor types that express B7-H4, following an initial accelerated titration design. The trial aims to provide insights into the efficacy of HS-20089 in treating these challenging cancers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors for whom standard treatments are ineffective or intolerable.

Not a fit: Patients with early-stage tumors or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors that are difficult to treat.

How similar studies have performed: While this approach is novel, similar studies targeting specific tumor markers have shown promise in early-phase trials.

Eligibility criteria

Inclusion Criteria:

1. Men or women aged more than or equal to (≥) 18 years
2. Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable
3. Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
4. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
5. Estimated life expectancy greater than (\>) 12 weeks
6. Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential
7. Sign Informed Consent Form

Exclusion Criteria:

1. Treatment with any of the following:

   1. Previous or current treatment with drugs targeting B7-H4
   2. Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
   3. Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
   4. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
   5. Known and untreated, or active central nervous system metastases.
2. Existing abnormal CTCAE≥grade 2 resulted from previous treatment
3. History of other malignancy
4. Inadequate bone marrow reserve or organ function
5. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
6. History of hypersensitivity to any active or inactive ingredient of HS-20089.
7. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
8. Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Cancer Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jiong Wu, PhD — Fudan University
• Study coordinator: Jiong Wu, PhD

Conditions: Advanced Solid Tumor, HS-20089, ADC, B7-H4