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A Phase I Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
Study Purpose
The overall objective of this Phase 1 study is to evaluate the safety, PK,and anti-tumor activity of daily oral dosing with HP518,selecting the RP2D of HP518 based on assessments of patients with progressive mCRPC in dose-escalation phase
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
1. Male, age ≥18. 2. Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II) 3. Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics. 4. Has metastatic disease documented by 2 or more bone lesions by bone scan or soft tissue disease progression observed by CT/MRI at the beginning of study. 5. the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy. 6. Must have recovered from toxicities related to any prior treatments. 7. Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy. 8. ECOG performance status score of 0 to 1.Exclusion Criteria:
1. Combination of research or commercially available drugs targeting AR. 2. Has had any other anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177LuPSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518. 3. Has gastrointestinal disorder affecting absorption (e.g., gastrectomy). 4. Has significant cardiovascular disease.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
This First in Human dose escalation and expansion study of HP518 in patients with progressive mCRPC after NHA and chemotherapy is being conducted not only to evaluate the safety and tolerability of orally administered HP518, but also to provide preliminary efficacy for the reference of future studies.
Arms
Experimental: Part 1 - Dose Escalation, 400mg/d (Cohort1)
Oral tablet(s), once daily in 28-day cycles
Experimental: Part 1 - Dose Escalation 500mg/d (Cohort 2)
Oral tablet(s), once daily in 28-day cycles
Experimental: Part 2 - Dose Expansion Oral tablet(s)
Oral tablet(s), once daily in 28-day cycles
Interventions
Drug: - HP518 - Dose Escalation
Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
Drug: - HP518 - Dose Escalation
Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
Drug: - HP518 -Dose Expansion
Part 2: Dose expansion Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
Beijing Cancer Hospital
Beijing, , 100142
Site Contact
Jun Guo
[email protected]
+86 28 8505 8465
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