Prostate Cancer
Conditions
Brief summary
This is an open-label, dose-escalation and expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLF4113 monotherapy in participants with metastatic prostate cancer. The Phase I trial consists of two parts: Phase Ia and Phase Ib. Phase Ia is a dose-escalation study of QLF4113 monotherapy to determine the recommended phase two dose and assess safety and PK. Then the study will proceed to Phase Ib, a dose-expansion study to further evaluate the preliminary efficacy and safety of QLF4113 monotherapy under the selected doses.
Interventions
DRUGQLF4113 for injection
A PSMA/CD3/CD2 antibody
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
* Participants voluntarily agree to participate and sign the informed consent form. * Male, aged ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. * Life expectancy ≥ 3 months. * Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine carcinoma or small cell carcinoma features. * Confirmed metastatic Castration-Resistant Prostate Cancer (mCRPC). * Failed or are intolerant to standard therapies * Adequate function of major organs as defined by the protocol. * Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy). * Prior to the first use of the investigational drug, recovery from all reversible adverse events (AEs) related to prior anticancer treatments
Exclusion criteria
* Previously treated with drugs targeting CD3 or CD2. * Significant Cardiovascular Diseases * Active, Uncontrolled Infections * Immunosuppressive Treatment before the first dose of the investigational drug * Clinically Uncontrolled Third-Space Fluid Accumulation * History of Other Malignancies within 5 years prior to the first dose of the investigational drug * Moderate to Severe Pulmonary Diseases significantly affecting lung function, * Current Hepatic Encephalopathy, Hepatorenal Syndrome, or Cirrhosis classified as Child-Pugh B or worse. * Allergy to the Investigational Drug or its Components. * Any Condition deemed by the investigator to increase study-related risks, interfere with the interpretation of study results, or otherwise render the participant unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) (Phase Ia) | From first dose of study treatment until the end of Cycle 1 (21 days) | Maximum tolerated dose is defined as the previous dose level at which 2 or more out of 2-6 participants experienced a dose-limited toxicity (DLT). |
| Maximum administered dose (MAD)(Phase Ia) | From first dose of study treatment until the end of Cycle 1 (21 days) | MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored. |
| recommended phase II dose (RP2D) | Through phase Ia completion, approximately 1 year. | The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ia study. |
| The incidence and severity of adverse events (AE) (Phase Ib) | Through phase Ia completion, approximately 1 year. | Incidence and severity of adverse events (AEs) evaluated according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCA) Version 6.0 (v6.0) and American Society for Transplantation and Cellular Therapy (ASTCT) |
| PSA50 response (Phase Ib) | From Screening to confirmed progressive disease (approximately 1 year) | Best response until progression, as defined by Response Evaluation Criteria in Solid Tumors （RECIST） version (v1.1) and Prostate Cancer Clinical Trials Working Group 3 (PCGW3). |
| Objective response rate (ORR) (phase Ib) | From Screening to confirmed progressive disease (approximately 1 year) | — |
Contacts
CONTACTJun Guo, Doctor
Outcome results
None listed