Clinical trial · Interventional
A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer
A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics and Clinical Activity of SYHA1807 Given Orally in Subjects With Extensive-Stage Small Cell Lung Cancer
- 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, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH) study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for SYHA1807 based on the safety, tolerability and pharmacokinetics (PK) profiles observed after oral administration of SYHA1807. The dose escalation study will be performed according to the 3+3 design. Once RP2D is identified, an expansion cohort (Part 2) of up to 12\~40 subjects will be enrolled to further evaluate the clinical activity and tolerability of SYHA1807 in subjects with extensive-stage Small Cell Lung Cancer (SCLC).
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 |
|---|---|---|---|
| Extensive-Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SYHA1807 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Escalation Cohort
- description
- Five dose levels will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration of SYHA1807 to the end of the first cycle (28 days).
- interventionNames
- Drug: SYHA1807
- type
- EXPERIMENTAL
- label
- Dose Expansion Cohort
- description
- Once the RP2D has been determined, an expansion cohort of up to 12\~40 subjects will be enrolled in order to better characterize the clinical activity and safety profile of the RP2D.
- interventionNames
- Drug: SYHA1807
Primary outcomes (7)
- measure
- Part 1:Number of Participants With Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of advanced SCLC; * ECOG(Eastern Cooperative Oncology Group) performance status of 0 or 1; * Measurable disease according to RECIST v1.1; * Recovered from all toxicities associated with previous treatments; * Life expectancy ≥ 3 months; * Adequate organ function; * Use of reliable contraceptive methods; * Signed informed consent from the patient; Exclusion Criteria: * Patients with primary malignant tumor other than small cell lung cancer; * Identified central nervous system metastasis (such as brain metastasis or meningeal metastasis); * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; * Inadequate washout period for previous anti-tumor therapy; * Previous treatment with any LSD1(lysine specific demethylase 1) inhibitor; * Unable to swallow oral medications; * History of serious systemic diseases; * History of serious autoimmune diseases； * HIV positive; * Pregnant or lactating women.
References
Publications (0)
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