Prostatic Neoplasms
Conditions
Brief summary
This study is designed to determine if experimental treatment with QLH12016 in combination with novel hormonal agent (NHA) is safe, tolerable, and has anti-cancer activity in patients with advanced prostate cancer.
Interventions
DRUGQLH12016
oral AR PROTAC
DRUGabiraterone acetate
oral CYP17 inhibitor
DRUGenzalutamide
oral androgen receptor inhibitor
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed the informed consent form. * Male, aged ≥ 18 years. * Life expectancy ≥ 3 months. * Histologically or cytologically confirmed prostate adenocarcinoma. * Metastatic prostate cancer. * Organ function meet protocol requirements. * Recovered from all reversible AEs related to previous anticancer treatments.
Exclusion criteria
* Previous treatment with the following drugs: 1. AR PROTAC class drugs. 2. Other systemic anticancer therapy within 3 weeks or 5 half-lives prior to the first administration of the study treatment. 3. Taditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration of the study treatment. 4. Drugs that may cause drug-drug interactions (DDI) with the study treatment. 5. Drugs known to prolong the QT interval or potentially cause torsades de pointes ventricular tachycardia * Presence of central nervous system metastases, leptomeningeal metastasis, or spinal cord compression. * Radiation therapy involving more than 25% of bone marrow within 4 weeks prior to the first administration of the investigational medicinal product; local radiation therapy within 2 weeks prior to the first administration of the investigational medicinal product. * Treatment with other investigational drugs or major surgery within 4 weeks. * Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption. * With severe cardiovascular or cerebrovascular diseases or related history. * Active, uncontrolled infections. * History of other significant malignancies within 5 years. * Moderate to severe pulmonary disease significantly affecting lung function. * According to the investigator's judgment, there are comorbidities that seriously endanger subject safety or affect the subject's ability to complete the study. * Allergy to any of the investigational medicinal products or their components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects with adverse events/serious adverse events (Phase Ib) | Throughout phase Ib (approximately 1 year) | Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline |
| The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol (Phase Ib) | From first dose of study treatment until the end of Cycle 1. | A DLT occurs during Cycle 1 (the DLT assessment period) that is assessed as related to study treatment. |
| Recommended phase II dose (RP2D) (Phase Ib) | Throughout phase Ib (approximately 1 year) | RP2D will be selected upon safety, PK and efficacy data. |
| Objective Response Rate (ORR) (Phase II) | From time of Informed Consent to confirmed progressive disease (approximately 1 year) | Best response until progression, as defined by RECIST 1.1 and PCWG3 |
Contacts
Primary ContactWanhai Xu, PHD
Outcome results
None listed