Trials / Recruiting
RecruitingNCT06224387
CTS2190 Phase I /II Clinical Study in Patients
A Multi-center, Open-label, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CTS2190 in Patients With Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- Sponsor
- CytosinLab Therapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a first in human study in patients with advanced or metastatic solid tumors. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific tumor types. The study drug, CTS2190, is a PRMT1 inhibitor administered orally. The study is planned to treat up to 224 participants.
Detailed description
This is a Phase 1/2 multi-center, open label study in solid tumor patients. Phase 1（Part1) is a dose escalation study of oral CTS2190 in patients with solid tumors，which is planned to treat up to 144 participants. Phase 2（Part2) is an open label, dose expansion study in specific tumor types. In both parts of the study, participants who tolerate the drug may continue the treatment until disease progression. The study duration for each subject is defined as beginning from 28 days prior to the first dose, until the subject withdrawal of informed consent, end of treatment, loss to follow-up or death, completes 48 weeks of continuous treatment or the study ends early, whichever occurs first. The end of study is defined as the date when the last subject completes the last visit specified in the protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CTS2190 capsules | 4-6 dose groups are pre-specified in Dose Escalation,and 4 arms in Dose Expansion. |
Timeline
- Start date
- 2023-06-26
- Primary completion
- 2025-07-31
- Completion
- 2025-10-31
- First posted
- 2024-01-25
- Last updated
- 2024-08-23
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06224387. Inclusion in this directory is not an endorsement.