Investigating HS-20093 combinations for advanced solid tumors

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 phase 1, open-label study evaluates the safety, tolerability, pharmacokinetics, and anti-tumor activity of HS-20093, a humanized antibody-drug conjugate targeting B7-H3, in patients with advanced solid tumors. The study involves a dose-escalation and expansion design, enrolling patients who have either progressed on or are intolerant to standard therapies, as well as those who have not received prior treatment for advanced disease. Participants will be monitored for adverse events and can continue therapy if well tolerated and showing clinical benefit.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least age of 18 years at screening;
* Histologically or cytologically confirmed, locally advanced or metastatic solid tumors

  1. Dose escalation part will enroll advanced solid tumor for which standard treatment has proven ineffective or unavailable or intolerable.
  2. Dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
* least one extra-cranial measurable lesion according to RECIST 1
* Agree to provide fresh or archival tumor tissue
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1
* Life expectancy \>= 12 weeks
* Agree to use medically accepted methods of contraception
* Men or women should be using adequate contraceptive measures throughout the study;
* Females subjects must not be pregnant at screening or have evidence of non-childbearing potential
* Signed and dated Informed Consent Form

Exclusion Criteria:

* Any of the following would exclude the subject from participation in the study:

treatment with any of the following: Previous or current treatment with B7-H3 targeted therapy Intolerable for any PD-L1 inhibitor, cetuximab, enzalutamide and cisplatin/ carboplatin Cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093 Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093 Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 Major surgery within 4 weeks prior to the first scheduled dose of HS-20093

* Subjects with previous or concurrent malignancies
* Inadequate bone marrow reserve or organ dysfunction
* Evidence of cardiovascular risk
* Evidence of current severe or uncontrolled systemic diseases
* Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
* Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first scheduled dose of HS-20093
* Subjects with current infectious diseases
* History of neuropathy or mental disorders
* Pregnant or lactating female
* History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093
* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator
* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Where it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Hua Zhong, PhD
• Email: shsxkyy@hotmail.com
• Phone: (0086)021-22200000

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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.