Trials / Unknown
UnknownNCT05785728
A Study of DB-1202 Monotherapy in Advanced Solid Tumors
Phase 1/2, Multicenter, Open-label, First-in-human Study of DB-1202 Monotherapy in Patients With Advanced Solid Malignant Tumors to Evaluate the Tolerability, Safety, Pharmacokinetics and Antitumor Activity
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- DualityBio Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1201 in subjects with advanced solid tumors.
Detailed description
This is a multicenter, non-randomized, open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts a rule based "3 + 3" design to identify MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and efficacy in selected solid malignant tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DB-1202 | Administered I.V. |
Timeline
- Start date
- 2023-06-28
- Primary completion
- 2024-02-28
- Completion
- 2024-02-28
- First posted
- 2023-03-27
- Last updated
- 2023-03-31
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05785728. Inclusion in this directory is not an endorsement.