Advanced Solid Tumor
Conditions
Keywords
small cell lung cancer, neuroendocrine carcinoma
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 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.
Interventions
DRUGHS-20108 Monotherapy
Intravenous (IV) Infusion
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD or MAD of HS-20108 | up to approximately 48 months | the maximum tolerated dose or maximum appropriate dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 (administered either as a monotherapy or in combination) |
| Area Under the Plasma Concentration-Time Curve (AUC) of HS-20108 | up to approximately 48 months. | AUC of HS-20108 (administered either as a monotherapy or in combination) |
| Immunogenicity (administered either as a monotherapy or in combination) | up to approximately 48 months. | Immunogenicity |
Countries
China
Contacts
CONTACTJie Chen, Doctor
Outcome results
None listed