NCT07636707Not yet recruitingPhase 1
QLF4113 in Participants With Metastatic Prostate Cancer
An Open-label, Multicenter Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLF4113 for Injection in Participants With Metastatic Prostate Cancer.
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- 20 Jul 2026
- Primary completion date
- 5 Jan 2028
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT07636707
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 140
- From 20 Jul 2026 to the primary completion date, 5 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously treated with drugs targeting CD3 or CD2.
- Immunosuppressive Treatment before the first dose of the investigational drug
- Allergy to the Investigational Drug or its Components.
Other illness
- Significant Cardiovascular Diseases
- Active, Uncontrolled Infections
- 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.
- 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.
Other
- Clinically Uncontrolled Third-Space Fluid Accumulation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.