QLF4113 in Participants With Metastatic Prostate Cancer
4. juni 2026 oppdatert av: Qilu Pharmaceutical Co., Ltd.
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.
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
140
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jun Guo, Doctor
- Telefonnummer: 0086-10- 88121122
- E-post: guoj307@126.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: QLF4113 dose escalation arm
|
A PSMA/CD3/CD2 antibody
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum tolerated dose (MTD) (Phase Ia)
Tidsramme: 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).
|
From first dose of study treatment until the end of Cycle 1 (21 days)
|
|
Maximum administered dose (MAD)(Phase Ia)
Tidsramme: 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.
|
From first dose of study treatment until the end of Cycle 1 (21 days)
|
|
recommended phase II dose (RP2D)
Tidsramme: 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.
|
Through phase Ia completion, approximately 1 year.
|
|
The incidence and severity of adverse events (AE) (Phase Ib)
Tidsramme: 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)
|
Through phase Ia completion, approximately 1 year.
|
|
PSA50 response (Phase Ib)
Tidsramme: 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).
|
From Screening to confirmed progressive disease (approximately 1 year)
|
|
Objective response rate (ORR) (phase Ib)
Tidsramme: From Screening to confirmed progressive disease (approximately 1 year)
|
From Screening to confirmed progressive disease (approximately 1 year)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
20. juli 2026
Primær fullføring (Antatt)
5. januar 2028
Studiet fullført (Antatt)
5. desember 2028
Datoer for studieregistrering
Først innsendt
4. juni 2026
Først innsendt som oppfylte QC-kriteriene
4. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- QLF4113-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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