Clinical trial · Interventional
A Study of HS248 in Patients With Advanced Solid Tumors
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HS248 in the Treatment of Patients With Advanced Solid Tumors
- 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 study is a non-random, open multi-center study This study is a non-random, open multi-center phase I study, aimed at evaluation period research, aimed at In the evaluation phase study, it aims to evaluate the safety, tolerance PK characteristics and preliminary anti-tumor activity of HS248 in patients with advanced solid tumors. The study was divided into 2 phases, including dose escalation and dose expansion。
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 |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS248 pieces | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HS248 pieces
- description
- dose escalation period: At this stage, it is planned that HS248 will adopt the traditional "3+3" method of increasing doses at four dose levels of 20 mg, 40 mg, 60 mg and 80 mg. All dosage components are divided into single administration stage and multiple administration stage. After 5 days of observation after single administration, it enters the stage of multiple administration. In the stage of multiple administration, HS248 is administered once a day (qd) for 28 days. a treatment cycle. 33 days after the first administration (the 5-day observation period in the single-administration phase and the first cycle in the multiple-administration phase) is the dose-limiting toxicity (DLT) observation period of this study
- interventionNames
- Drug: HS248 pieces
Primary outcomes (2)
- measure
- Safety and tolerability
- timeFrame
- From first dose of HS248 through 28 days after the last HS248 treatment (up to 2 years); each cycle is 28 days
- description
- To examine the incidence of clinical and laboratory adverse events after multiple doses of HS-248 in the dose escalation and dose expansion phases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily participate in this clinical trial, understand and follow the research procedures and voluntarily sign the ICF; 2. Male or female, age ≥18 when signing the ICF; 3. Expected survival period ≥ 12 weeks; 4. Patients with advanced solid tumors confirmed by histology/cytology, who have progressed through standard treatment, have toxicity intolerance, or have no standard treatment plan (patients with multiple solid tumors are included in the dose-escalation phase, and the population included in the dose-expansion phase will be based on dose escalation phase study data and the potential advantageous population of similar drugs); 5. Eastern Cooperative Oncology Group (ECOG) physical status score 0-1 Exclusion Criteria: 1. Symptomatic or untreated central nervous system metastasis or primary central nervous system malignancy; 2. Other known malignant tumors in the past 5 years, except cured localized tumors, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate; 3. Previous history of autoimmune diseases, stem cell transplantation or organ transplantation; 4. Known drug-induced liver injury, chronic active hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, persistent extrahepatic obstruction caused by gallstones, cirrhosis or portal hypertension; 5. Peptic ulcer and/or gastrointestinal bleeding at present or in the past; 6. Gastrointestinal dysfunction that may limit the absorption of the test drug, including motility disorders, malabsorption syndrome or inflammatory bowel disease;
References
Publications (0)
Data not yet available