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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: HS-20108 Monotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 502
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jie Chen, Doctor; Phone Number: +8613660217442; Email: Chen0jie@hotmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Jie Chen, Doctor; Phone Number: +8613660217442; Email: Chen0jie@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-20108 Ia; Phase Ia Dose Escalation	Drug: HS-20108 Monotherapy; Intravenous (IV) Infusion
Experimental: HS-20108 Ib Cohort1; Phase Ib Dose Expansion Cohort 1: Participants with small cell lung cancer will receive varying doses of HS-20108	Drug: HS-20108 Monotherapy; Intravenous (IV) Infusion
Experimental: HS-20108 Ib Cohort2; Phase Ib Dose Expansion Cohort 2: Participants with neuroendocrine carcinoma will receive varying doses of HS-20108	Drug: HS-20108 Monotherapy; Intravenous (IV) Infusion
Experimental: HS-20108 Ib Cohort3; Phase Ib Dose Expansion Cohort 3: Participants with other advanced solid tumors will receive varying doses of HS-20108	Drug: HS-20108 Monotherapy; Intravenous (IV) Infusion
Experimental: HS-20108 and Adebrelimab Ia&Ib; Phase Ia Dose Escalation Phase Ib Dose Expansion	Drug: HS-20108 Monotherapy; Intravenous (IV) Infusion
Experimental: HS-20108 and SHR-7787 Ia &Ib; Phase Ia Dose Escalation Phase Ib Dose Expansion	Drug: HS-20108 Monotherapy; Intravenous (IV) Infusion
Experimental: HS-20108、Adebrelimab and SHR-7787 Ia &Ib; Phase Ia Dose Escalation Phase Ib Dose Expansion	Drug: HS-20108 Monotherapy; Intravenous (IV) Infusion
Experimental: HS-20108 and Cisplatin / Carboplatin Ia&Ib; Phase Ia Dose Escalation Phase Ib Dose Expansion	Drug: HS-20108 Monotherapy; Intravenous (IV) Infusion
Experimental: HS-20108、Adebrelimab and Cisplatin / Carboplatin Ia&Ib; Phase Ib Dose Expansion	Drug: HS-20108 Monotherapy; Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD or MAD of HS-20108	the maximum tolerated dose or maximum appropriate dose	up to approximately 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to approximately 48 months
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.	up to approximately 48 months.
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).	up to approximately 48 months.
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.	up to approximately 48 months.
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.	up to approximately 48 months.
overall survival (OS)	OS is defined as time from first study treatment to death due to any cause.	up to approximately 48 months.
Observed maximum plasma concentration (Cmax) of HS-20108	Cmax of HS-20108 (administered either as a monotherapy or in combination)	up to approximately 48 months.
Area Under the Plasma Concentration-Time Curve (AUC) of HS-20108	AUC of HS-20108 (administered either as a monotherapy or in combination)	up to approximately 48 months.
Immunogenicity (administered either as a monotherapy or in combination)	Immunogenicity	up to approximately 48 months.

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company
• Investigators: Principal Investigator: Ying Cheng, BMed, Jilin Provincial Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: small cell lung cancer; neuroendocrine carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Small Cell Lung Carcinoma; Carcinoma, Neuroendocrine
• Other Study ID Numbers: HS-20108-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No