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

NCT06936735 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-20108-101
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Keywords

small cell lung cancer; neuroendocrine carcinoma

Outcome Measures

Primary Outcomes (1)

• MTD or MAD of HS-20108

  the maximum tolerated dose or maximum appropriate dose

  up to approximately 48 months

Secondary Outcomes (8)

• Incidence of adverse events (AEs)

  up to approximately 48 months

• Objective response rate (ORR) assessed by investigator

  up to approximately 48 months.

• Disease Control Rate (DCR)

  up to approximately 48 months.

• Duration of response (DOR)

  up to approximately 48 months.

• Progression-free survival (PFS)

  up to approximately 48 months.

Study Arms (4)

HS-20108 Ia

EXPERIMENTAL

Phase Ia Dose Escalation

Drug: HS-20108 Monotherapy

HS-20108 Ib Cohort1

EXPERIMENTAL

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

Drug: HS-20108 Monotherapy

HS-20108 Ib Cohort2

EXPERIMENTAL

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

Drug: HS-20108 Monotherapy

HS-20108 Ib Cohort3

EXPERIMENTAL

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

Drug: HS-20108 Monotherapy

Interventions

HS-20108 Monotherapy DRUG

Intravenous (IV) Infusion

HS-20108 Ia; HS-20108 Ib Cohort1; HS-20108 Ib Cohort2; HS-20108 Ib Cohort3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Jilin Cancer Hospital

Jilin, Jilin, 130000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Ying Cheng, BMed

  Jilin Provincial Tumor Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Cheng, BMed

CONTACT

(0086)0431-80596003; jl.cheng@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 20, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): November 27, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

CN (1)