A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorShenzhen Ionova Life Sciences Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Written informed consent obtained.

Male aged ≥ 18 years.

Histologically confirmed adenocarcinoma of the prostate.

Castration resistant prostate cancer with serum testosterone <50 ng/dL.

Disqualifiers

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.

History of pituitary or adrenal dysfunction.

Poorly controlled diabetes mellitus.

Clinically significant abnormality in serum potassium and sodium.

Trial design

Treatments tested in this trial

  • INV-9956

Treatment groups

84 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.