None listed
Conditions
Brief summary
This study is testing a new medicine called IDB-1829 for advanced prostate cancer that no longer responds to standard hormone treatments. Who is it for? You may be eligible for this study if you are an adult with prostate cancer, where the cancer has stopped responding to hormone therapy. Participants in this study must have also received at least one prior treatment for resistant prostate cancer. Study details All participants in this study will be asked to take a dose of the new medicine daily in 21 day cycles. The number of cycles will depend on how the participant is responding to the treatment. Participants will also be asked to provide blood samples throughout the treatment, and be followed up for review of safety and via scans to assess changes in the cancer. It is hoped that this research will help determine if the new medicine is a viable option for the treatment of hormone resistant prostate cancer.
Interventions
-Participants will receive IDB-1829 orally (by mouth) once daily (QD) in continuous 21-day treatment cycles at four escalating dose levels- DL 1 (1 mg), DL 2 (2 mg), DL 3 (4mg), DL 4 (7 mg).
-Treatment duration will continue until unacceptable toxicity, disease progression, or study discontinuation criteria are met (Participant withdrawal of consent, Disease progression (radiographic or clinical), Investigator judgment that continued treatment is not in the participant's best interest, Pregnanc
-Participants will receive IDB-1829 orally (by mouth) once daily (QD) in continuous 21-day treatment cycles at four escalating dose levels- DL 1 (1 mg), DL 2 (2 mg), DL 3 (4mg), DL 4 (7 mg). -Treatment duration will continue until unacceptable toxicity, disease progression, or study discontinuation criteria are met (Participant withdrawal of consent, Disease progression (radiographic or clinical), 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) -Up to 18 participants will be enrolled in this part with 4 planned cohorts - 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). - The Adherence to the intervention will be supervised by the Principal Investigator/ Study staff/ Nurse.
Sponsors
Interdict Bio
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Confirmed diagnosis of prostate cancer (adenocarcinoma) that has spread to other parts of the body (metastatic disease) 3. Cancer has stopped responding to hormone therapy (castration-resistant prostate cancer, or mCRPC) 4. Currently on hormone therapy (androgen deprivation therapy) or has had surgical removal of the testicles, with testosterone levels at or below 50 ng/dL 5. Cancer has gotten worse on or after the most recent treatment 6. Able to carry out normal daily activities with little or no physical limitation (ECOG performance status 0 or 1) 7. Has received at least one prior treatment for mCRPC, including at least one hormonal therapy such as enzalutamide or abiraterone
Exclusion criteria
1. Received chemotherapy, immunotherapy, targeted therapy, or another investigational cancer treatment within 21 days before starting study treatment (or within 6 weeks for prior radiopharmaceutical therapy such as lutetium-177 PSMA) 2. Received radiation therapy within 28 days before starting study treatment 3. Prostate cancer with small cell or neuroendocrine features on any prior or current biopsy 4. Stroke or mini-stroke (TIA) within the past 6 months 5. History of organ transplant
Outcome results
None listed