Clinical trial NCT06936735: Phase I Study of HS-20108 in Participants With Advanced Solid Tumors
Official title: A Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20108 in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: small cell lung cancer
neuroendocrine carcinoma
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2025-04-20
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MTD or MAD of HS-20108
timeFrame: up to approximately 48 months
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: up to approximately 48 months
measure: Objective response rate (ORR) assessed by investigator
timeFrame: up to approximately 48 months.
measure: Disease Control Rate (DCR)
timeFrame: up to approximately 48 months.
measure: Duration of response (DOR)
timeFrame: up to approximately 48 months.
measure: Progression-free survival (PFS)
timeFrame: up to approximately 48 months.
measure: overall survival (OS)
timeFrame: up to approximately 48 months.
measure: Observed maximum plasma concentration (Cmax) of HS-20108
timeFrame: up to approximately 48 months.
measure: Area Under the Plasma Concentration-Time Curve (AUC) of HS-20108
timeFrame: up to approximately 48 months.
Other outcomes:
Locations:
city: Jilin
country: China
facility: Jilin Cancer Hospital
state: Jilin
Study officials:
affiliation: Jilin Provincial Tumor Hospital
name: Ying Cheng, BMed
role: PRINCIPAL_INVESTIGATOR
References: