HS-20108 in people with 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 multicenter, open-label Phase I trial has two parts: a dose-escalation phase to find the maximum tolerated dose and a dose-expansion phase to explore early proof-of-concept in selected tumor types. HS-20108 will be given as monotherapy, with evaluation of safety, tolerability, pharmacokinetics, and preliminary efficacy. Participants must have measurable disease, good performance status, and available tumor tissue. The study will enroll adults with pathologically confirmed advanced solid tumors treated at Fudan University Shanghai Cancer Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men or women aged more than or equal to (≥) 18 years.
2. Participants with pathologically confirmed advanced solid tumors.
3. At least one measurable lesion in accordance with RECIST 1.1
4. Fresh or archival tumor tissue available for submission.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1.
6. Estimated life expectancy \>12 weeks.
7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
8. Females must have evidence of non-childbearing potential.
9. Signed and dated Informed Consent Form.

Exclusion Criteria:

1. Treatment with any of the following:

   Having received cytotoxic chemotherapy agents, investigational drugs, Chinese medicine treatment with anti-tumor indications, or other anti-tumor therapy (including endocrine therapy, molecular targeted therapy, or biotherapy) within 14 days before the first dose of study treatment.

   Having received macromolecular anti-tumor drug therapy (including immunotherapy, such as monoclonal antibody drugs and bispecific antibody drugs) within 28 days before the first dose of study treatment.

   Local radiotherapy 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.

   Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
2. Inadequate bone marrow reserve or serious organ dysfunction.
3. Uncontrolled pleural effusion or ascites or pericardial effusion.
4. Known and untreated, or active central nervous system metastases.
5. Active autoimmune diseases or active infectious disease
6. Known to have interstitial pneumonia or immune pneumonia
7. History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20108
8. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.
9. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
10. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
11. History of neuropathy or mental disorders, including epilepsy and dementia.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jie Chen, Doctor
• Email: Chen0jie@hotmail.com
• Phone: +8613660217442

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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.