Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT07190469
Brief Summary:
The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including triple negative breast cancer (TNBC), and to determine a recommended Phase 2 dose level for future studies in TNBC.
Detailed Description:
This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PQ203 in patients with selected advanced solid tumors. PQ203 will be administered as a once-weekly intravenous infusion.
The study consists of two parts: Phase 1A (dose escalation/expansion) and Phase 1B (dose optimization).
* Phase 1A will employ a dose-escalation design in patients with advanced solid tumors to assess the safety and tolerability of PQ203 as monotherapy and to establish a provisional Recommended Phase 2 Dose (RP2D). A dose-expansion component will further evaluate the provisional RP2D in one or more selected tumor types.
* Phase 1B will assess the provisional RP2D and further characterize safety, pharmacokinetics, and preliminary efficacy.
Endpoints:
* Primary Endpoints: Incidence of treatment-emergent adverse events (TEAEs) and determination of the RP2D.
* Secondary Endpoints: Pharmacokinetic profile of PQ203 and its payload (MMAE), and preliminary evidence of antitumor activity.
Study:
NCT07190469
Study Brief:
Protocol Section:
NCT07190469