Trial summary
Participants will receive IDB-1829 orally once daily in combination with enzalutamide 160 mg orally once daily, administered in continuous 21-day treatment cycles. IDB-1829 will be evaluated using a dose-escalation design, with doses ranging from 1 mg to 7 mg once daily, depending on the participant cohort and dose level assigned.
Treatment will continue until unacceptable toxicity, disease progression, or study discontinuation criteria (Investigator judgment that continued treatment is not in the participant's best interest, Pregnancy (of a Women of Childbearing Potential (WOCBP) partner), Sponsor decision to terminate the study) are met.
Up to 6 participants will be enrolled in this part.
Study Duration (per participant): Screening up to 28 days; treatment until disease progression, unacceptable toxicity, or other discontinuation criterion; 30-day safety follow-up (SFU); long-term follow-up every 3 months until 2 years after the last participant ends treatment or end of study (EOS).
Trial details
Short title
IDB-1829-1001
Diagnosis
Prostate cancer
Type of treatment
Medical Oncology
Phase
I
Locations
Who can participate
Clinical trials can have restrictive criteria of who can and can’t participate, talk to your healthcare provider if you are interested in this clinical trial.