Clinical trial · Interventional
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
NCT06936735CI-TRIAL-00113286recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-20108 Monotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- HS-20108 Ia
- description
- Phase Ia Dose Escalation
- interventionNames
- Drug: HS-20108 Monotherapy
- type
- EXPERIMENTAL
- label
- HS-20108 Ib Cohort1
- description
- Phase Ib Dose Expansion Cohort 1: Participants with small cell lung cancer will receive varying doses of HS-20108
- interventionNames
- Drug: HS-20108 Monotherapy
- type
- EXPERIMENTAL
- label
- HS-20108 Ib Cohort2
- description
- Phase Ib Dose Expansion Cohort 2: Participants with neuroendocrine carcinoma will receive varying doses of HS-20108
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.