Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

CT-95 i avancerede kræftformer forbundet med mesothelinekspression

3. november 2026 opdateret af: Context Therapeutics Inc.

Fase 1-undersøgelse af CT-95 i avancerede kræftformer forbundet med mesothelin-ekspression

This is a Phase 1a/1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Phase 1a Dose Escalation: Participants with ovarian epithelial tumors, primary peritoneal or fallopian tube cancer (PROC), epithelioid mesothelioma, lung adenocarcinoma, pancreatic adenocarcinoma, colorectal cancer, cholangiocarcinoma, and gastric/GEJ adenocarcinomas will be enrolled in one of approximately 9 dose escalation cohorts to assess the safety and tolerability of CT-95, as well as determine the maximum tolerated dose (MTD) or other recommended dose(s) for expansion (RDE[s]) for further dose expansion cohorts.

Participants will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle.

Phase 1b Dose Expansion: The RDE(s) of CT-95 determined in Phase 1a will be evaluated in 2-4 indication-specific expansion cohorts of up to 20 subjects each (i.e. up to 80 participants total). Different indications, dose levels, and/or schedules may be explored. The expansion doses and/or dosing schedules for Phase 1b will be determined by Sponsor in conjunction with SRC based upon all available safety, PK, PD, biomarker, and preliminary efficacy data from Phase 1a.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Context Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Context Investigational Site
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49546
        • Context Investigational Site
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Context Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Context Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Context Investigational Site
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • Context Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • ECOG 0 or 1
  • Subjects with evaluable disease per RECIST 1.1 or mRECIST
  • Subjects with adequate organ function.
  • Subjects with advanced cancers associated with mesothelin expression

Exclusion Criteria:

  • Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study.
  • Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy
  • Concurrent participation in another investigational clinical trial.
  • Evidence of leptomeningeal disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CT-95

Phase 1a: Dose Escalation - each dose cohort will assess toxicity 28 days following the first dose of CT95 anticipate a total of 8 dose cohorts.

Phase 1b: Dose Expansion - approximately 80 participants will be evaluated in 2-4 indication-specific expansion cohorts.
Medicin: CT-95

MSLN bispecific antibody to be administered according to the dose and schedule of the assigned cohort until documentation of disease progression (or confirmed disease progression), unacceptable toxicity, or participant/physician decision.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Determine the MTD or RD of CT-95 [Safety and Tolerability]
Tidsramme: From date of first dose of CT-95 until 28 days following the first dose.

The frequency of dose-limiting toxicities (DLTs) will be analyzed along with safety and tolerability measures to determine the MTD or RD of CT-95.
From date of first dose of CT-95 until 28 days following the first dose.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Tidsramme: From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.

The frequency and severity of adverse events, serious adverse events, and adverse events of special interest will be analyzed.
From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate Response Rates [Anti-tumor Activity]
Tidsramme: At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first

Overall response rates will be calculated using RECIST 1.1 (and mRECIST for patients with mesothelioma) for CT-95.
At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first
Evaluate Progression-free Survival [Anti-tumor Activity]
Tidsramme: At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.

PFS will be summarized using RECIST 1.1 (and mRECIST for patients with mesothelioma) for CT-95.
At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.
Evaluate Overall Survival [Survival]
Tidsramme: From the time of the first dose of CT-95 until approximately two years post-first dose.

Overall survival will be summarized for CT-95.
From the time of the first dose of CT-95 until approximately two years post-first dose.
Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics]
Tidsramme: From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.

Serum concentrations of CT-95 analyzed as a function of time relative to dosing will be calculated.
From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.
Evaluate the Area Under the Curve (AUC) [Pharmacokinetics]
Tidsramme: From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first.

The AUC of CT-95 analyzed as a function of time relative to dosing will be calculated.
From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first.
Evaluate Anti-Drug Antibodies [Immunogenicity]
Tidsramme: From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.

Incidence and titer of ADAs will be evaluated.
From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Context Therapeutics Inc.

Efterforskere

  • Studieleder: Karen Chagin, MD, Context Therapeutics Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. marts 2025

Primær færdiggørelse (Faktiske)

9. oktober 2026

Studieafslutning (Faktiske)

9. oktober 2026

Datoer for studieregistrering

Først indsendt

18. december 2024

Først indsendt, der opfyldte QC-kriterier

24. december 2024

Først opslået (Faktiske)

1. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CNTX-CT95-101

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner