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Taking people in ChinaPhase 1

Tests HS-20108 safety in adults with advanced solid tumors

Tests the drug HS-20108, given by vein, in adults with advanced solid tumors.

Key facts

Who runs it
Hansoh BioMedical R&D Company
Where
Shanghai, ChinaSee the site
Trial code
Registry title
A Phase I Study of HS-20108 in Participants With Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
502 people, planned
Started
29 May 2025
Expected to end
28 Feb 2029
Type of study
Interventional, 9 groups
Treatments tested
  • HS-20108 Monotherapy
Record updated
2 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors confirmed by tissue tests. They must have at least one tumor that can be measured on scans.

Age
18 years or older
Sex
Men and women can join.
Disease stage
Advanced solid tumors confirmed by pathology, with at least one measurable lesion (RECIST 1.1).
Earlier treatment
Cannot join if recent anti-tumor treatment was given: within 14 days for chemotherapy, investigational drugs, targeted, endocrine or biotherapy; within 28 days for antibody drugs such as immunotherapy. Recent radiotherapy or major surgery also rules people out.
Biomarker or test result
Fresh or archival tumor tissue must be available to submit.

Main reasons for not taking part

  • Poor bone marrow reserve or serious organ dysfunction
  • Uncontrolled fluid around the lungs, belly or heart
  • Untreated or active cancer spread to the brain or spinal cord
  • Active autoimmune disease or active infection
  • Interstitial pneumonia or immune pneumonia

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Men or women aged more than or equal to (≥) 18 years
  • Participants with pathologically confirmed advanced solid tumors
  • At least one measurable lesion in accordance with RECIST 1.1
  • Fresh or archival tumor tissue available for submission
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0~1
  • Estimated life expectancy >12 weeks
  • 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
  • Females must have evidence of non-childbearing potential
  • Signed and dated Informed Consent Form

Who cannot take part

  • 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
  • Active autoimmune diseases or active infectious disease
  • History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20108
  • History of neuropathy or mental disorders, including epilepsy and dementia
  • Inadequate bone marrow reserve or serious organ dysfunction
  • Uncontrolled pleural effusion or ascites or pericardial effusion
  • Known and untreated, or active central nervous system metastases
  • Known to have interstitial pneumonia or immune pneumonia
  • The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator
  • The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator
  • Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study

Where in China

  • Fudan University Shanghai Cancer CenterShanghai, ChinaContact: Jie Chen, DoctorTaking people

About the trial

What the trial wants to find out

This is a Phase I clinical study of HS-20108. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors.

The 9 groups in the trial

  • HS-20108 IaTreatment being tested

    Phase Ia Dose Escalation

    Treatment: HS-20108 Monotherapy

  • HS-20108 Ib Cohort1Treatment being tested

    Phase Ib Dose Expansion Cohort 1: Participants with small cell lung cancer will receive varying doses of HS-20108

    Treatment: HS-20108 Monotherapy

  • HS-20108 Ib Cohort2Treatment being tested

    Phase Ib Dose Expansion Cohort 2: Participants with neuroendocrine carcinoma will receive varying doses of HS-20108

    Treatment: HS-20108 Monotherapy

  • HS-20108 Ib Cohort3Treatment being tested

    Phase Ib Dose Expansion Cohort 3: Participants with other advanced solid tumors will receive varying doses of HS-20108

    Treatment: HS-20108 Monotherapy

  • HS-20108 and Adebrelimab Ia&IbTreatment being tested

    Phase Ia Dose Escalation Phase Ib Dose Expansion

    Treatment: HS-20108 Monotherapy

  • HS-20108 and SHR-7787 Ia &IbTreatment being tested

    Phase Ia Dose Escalation Phase Ib Dose Expansion

    Treatment: HS-20108 Monotherapy

  • HS-20108、Adebrelimab and SHR-7787 Ia &IbTreatment being tested

    Phase Ia Dose Escalation Phase Ib Dose Expansion

    Treatment: HS-20108 Monotherapy

  • HS-20108 and Cisplatin / Carboplatin Ia&IbTreatment being tested

    Phase Ia Dose Escalation Phase Ib Dose Expansion

    Treatment: HS-20108 Monotherapy

  • HS-20108、Adebrelimab and Cisplatin / Carboplatin Ia&IbTreatment being tested

    Phase Ib Dose Expansion

    Treatment: HS-20108 Monotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20108 in Participants With Advanced Solid Tumors
Plain-language title
Tests HS-20108 safety in adults with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 June 2026