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:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT06609005
Brief Summary:
This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.
Detailed Description:
This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.
The entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion.
Phase 1 dose escalation of INV-9956 follows a real time monitored, PK/PD and safety guided scheme with a traditional 3+3 design for DLT assessment.
Phase 2 aims to reassure the safety profile and better define efficacy. Phase 2 consists of up to 2 cohorts by different AR gene status:
* Cohort A: AR mutant CRPC
* Cohort B: AR wide-type CRPC (optional) Currently enrolling patients under Phase 2.
Study:
NCT06609005
Study Brief:
Protocol Section:
NCT06609005