Trials / Unknown
UnknownNCT04404543
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 71 (estimated)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SYHA1807 | Escalation Cohort Administration: Orally |
| DRUG | SYHA1807 | Dose Expansion Cohort Administration: Orally |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
- First posted
- 2020-05-27
- Last updated
- 2020-05-27
Source: ClinicalTrials.gov record NCT04404543. Inclusion in this directory is not an endorsement.