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

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: HS-20108 Monotherapy

• Registration Number: NCT06936735
• Lead Sponsor: Hansoh BioMedical R&D Company

Brief 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.

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 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 based on the study data from Phase Ia, the translational medicine research data and R\&D progress in the field.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study Start: 2025-04-17
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Primary Completion: 2027-10-28
• Study Completion: 2027-11-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 502

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HS-20108 Ia	HS-20108 Monotherapy	Phase Ia Dose Escalation
HS-20108 Ib Cohort1	HS-20108 Monotherapy	Phase Ib Dose Expansion Cohort 1: Participants with small cell lung cancer will receive varying doses of HS-20108
HS-20108 Ib Cohort2	HS-20108 Monotherapy	Phase Ib Dose Expansion Cohort 2: Participants with neuroendocrine carcinoma will receive varying doses of HS-20108
HS-20108 Ib Cohort3	HS-20108 Monotherapy	Phase Ib Dose Expansion Cohort 3: Participants with other advanced solid tumors will receive varying doses of HS-20108

Primary Outcome Measures

Name	Time	Method
MTD or MAD of HS-20108	up to approximately 48 months	the maximum tolerated dose or maximum appropriate dose

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up to approximately 48 months.	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.
overall survival (OS)	up to approximately 48 months.	OS is defined as time from first study treatment to death due to any cause.
Observed maximum plasma concentration (Cmax) of HS-20108	up to approximately 48 months.	Cmax of HS-20108
Area Under the Plasma Concentration-Time Curve (AUC) of HS-20108	up to approximately 48 months.	AUC of HS-20108
Incidence of adverse events (AEs)	up to approximately 48 months	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.
Objective response rate (ORR) assessed by investigator	up to approximately 48 months.	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.
Disease Control Rate (DCR)	up to approximately 48 months.	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).
Duration of response (DOR)	up to approximately 48 months.	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.

Trial Locations

Locations (1)

Jilin Cancer Hospital; 🇨🇳 Jilin, Jilin, China