A Phase 1 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

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.

Sex: MALE
Minimum Age: 18 Years
Healthy Volunteers: No
Age Groups: ADULT, OLDER_ADULT

Inclusion Criteria:

1. Written informed consent obtained.
2. Male aged ≥ 18 years.
3. Histologically confirmed adenocarcinoma of the prostate.
4. Castration resistant prostate cancer with serum testosterone 3 months.

Exclusion Criteria:

1. Have a medical condition such as Crohn’s disease or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.
2. History of pituitary or adrenal dysfunction.
3. Poorly controlled diabetes mellitus.
4. Clinically significant abnormality in serum potassium and sodium.
5. Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
6. Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
7. History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.
8. Prolonged QTcF interval.
9. Active infection or other medical condition that would make corticosteroid contraindicated.