Trials / Recruiting
RecruitingNCT04387916
A Study of KC1036 in Patients with Advanced Solid Tumors
A Phase I, Open-label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of KC1036 in the Patients with Advanced Recurrent or Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 207 (estimated)
- Sponsor
- Beijing Konruns Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KC1036 | Part 1: Dose-escalation phase , KC1036 10mg\~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3\~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2. |
Timeline
- Start date
- 2020-09-04
- Primary completion
- 2025-10-31
- Completion
- 2025-12-31
- First posted
- 2020-05-14
- Last updated
- 2024-10-17
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04387916. Inclusion in this directory is not an endorsement.