QLF4113 in Participants With Metastatic Prostate Cancer (NCT07636707) | Clinical Trial Compass
Not Yet RecruitingPhase 1
QLF4113 in Participants With Metastatic Prostate Cancer
140 participantsStarted 2026-07-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inves…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) (Phase Ia)
Timeframe: From first dose of study treatment until the end of Cycle 1 (21 days)
2
Maximum administered dose (MAD)(Phase Ia)
Timeframe: From first dose of study treatment until the end of Cycle 1 (21 days)
3
recommended phase II dose (RP2D)
Timeframe: Through phase Ia completion, approximately 1 year.
4
The incidence and severity of adverse events (AE) (Phase Ib)
Timeframe: Through phase Ia completion, approximately 1 year.
5
PSA50 response (Phase Ib)
Timeframe: From Screening to confirmed progressive disease (approximately 1 year)
6
Objective response rate (ORR) (phase Ib)
Timeframe: From Screening to confirmed progressive disease (approximately 1 year)