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Advanced Solid TumorPhase 1NCT06936735

A Phase I Study of HS-20108 in Participants With Advanced Solid Tumors

A Phase 1 study testing HS-20108 Monotherapy in people with Advanced Solid Tumor, run by Hansoh BioMedical R&D Company at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
HS-20108 Monotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
1 siteChina
Study dates
29 May 2025to 28 Feb 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 join

  • 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.
  • Inadequate bone marrow reserve or serious organ dysfunction.
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  • Uncontrolled pleural effusion or ascites or pericardial effusion.
  • Known and untreated, or active central nervous system metastases.
  • Active autoimmune diseases or active infectious disease
  • Known to have interstitial pneumonia or immune pneumonia
  • History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20108
  • 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.
  • History of neuropathy or mental disorders, including epilepsy and dementia.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jie Chen, Doctor contact

+8613660217442

Chen0jie@hotmail.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Jie Chen, Doctor, +8613660217442, Chen0jie@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20108 in Participants With Advanced Solid Tumors

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.

Read the detailed description

This is a multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors. The study consists of Phase Ia (dose escalation) and Phase Ib (dose expansion). In Phase Ia, dose escalation in monotherapy and combination therapy will conduct to identify the maximum tolerated dose (MTD) in patients with advanced solid tumors. In Phase Ib, potential indications (such as small cell lung cancer or neuroendocrine carcinoma) will be selected for the early proof-of-concept study of HS-20108 at different doses in monotherapy and combination therapy based on the study data from Phase Ia, the translational medicine research data and R\&D progress in the field.

Being tested
HS-20108 Monotherapy
Keywords
small cell lung cancer, neuroendocrine carcinoma
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20108 MonotherapyDrug

    Intravenous (IV) Infusion

Study groups in NCT06936735
Study groupRoleWhat they receive
HS-20108 IaExperimentalPhase Ia Dose Escalation
Receives: Drug: HS-20108 Monotherapy
HS-20108 Ib Cohort1ExperimentalPhase Ib Dose Expansion Cohort 1: Participants with small cell lung cancer will receive varying doses of HS-20108
Receives: Drug: HS-20108 Monotherapy
HS-20108 Ib Cohort2ExperimentalPhase Ib Dose Expansion Cohort 2: Participants with neuroendocrine carcinoma will receive varying doses of HS-20108
Receives: Drug: HS-20108 Monotherapy
HS-20108 Ib Cohort3ExperimentalPhase Ib Dose Expansion Cohort 3: Participants with other advanced solid tumors will receive varying doses of HS-20108
Receives: Drug: HS-20108 Monotherapy
HS-20108 and Adebrelimab Ia&IbExperimentalPhase Ia Dose Escalation Phase Ib Dose Expansion
Receives: Drug: HS-20108 Monotherapy
HS-20108 and SHR-7787 Ia &IbExperimentalPhase Ia Dose Escalation Phase Ib Dose Expansion
Receives: Drug: HS-20108 Monotherapy
HS-20108、Adebrelimab and SHR-7787 Ia &IbExperimentalPhase Ia Dose Escalation Phase Ib Dose Expansion
Receives: Drug: HS-20108 Monotherapy
HS-20108 and Cisplatin / Carboplatin Ia&IbExperimentalPhase Ia Dose Escalation Phase Ib Dose Expansion
Receives: Drug: HS-20108 Monotherapy
HS-20108、Adebrelimab and Cisplatin / Carboplatin Ia&IbExperimentalPhase Ib Dose Expansion
Receives: Drug: HS-20108 Monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD or MAD of HS-20108

    the maximum tolerated dose or maximum appropriate dose

    Measured: up to approximately 48 months

Secondary outcomes (9)

  1. Incidence of adverse events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant administered an investigational product, which may present with symptoms, signs, disease, or laboratory abnormalities, but do not necessarily have a causality with the investigational product.

    Measured: up to approximately 48 months

  2. Objective response rate (ORR) assessed by investigator

    ORR is defined as the percentage of patients with a CR or PR that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.

    Measured: up to approximately 48 months.

  3. Disease Control Rate (DCR)

    Disease control was defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks).

    Measured: up to approximately 48 months.

  4. Duration of response (DOR)

    Duration of response assessed by RECIST 1.1. Duration of response was defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression (PD) or death.

    Measured: up to approximately 48 months.

  5. Progression-free survival (PFS)

    Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival. Progression-free survival was defined as the time from date of first dose until the documentation of objective PD or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.

    Measured: up to approximately 48 months.

  6. overall survival (OS)

    OS is defined as time from first study treatment to death due to any cause.

    Measured: up to approximately 48 months.

  7. Observed maximum plasma concentration (Cmax) of HS-20108

    Cmax of HS-20108 (administered either as a monotherapy or in combination)

    Measured: up to approximately 48 months.

  8. Area Under the Plasma Concentration-Time Curve (AUC) of HS-20108

    AUC of HS-20108 (administered either as a monotherapy or in combination)

    Measured: up to approximately 48 months.

  9. Immunogenicity (administered either as a monotherapy or in combination)

    Immunogenicity

    Measured: up to approximately 48 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2025
  2. Study start29 May 2025
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
502 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06936735
Sponsor's protocol ID
HS-20108-101
Status last verified
May 2026
First submitted
14 Apr 2025
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20108 Monotherapy in people with Advanced Solid Tumor, run by Hansoh BioMedical R&D Company at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jie Chen, Doctor (+8613660217442, Chen0jie@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD or MAD of HS-20108 (time frame: up to approximately 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06936735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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