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En undersøgelse af PHST001 i avancerede faste tumorer

30. september 2026 opdateret af: Pheast Therapeutics

En åben mærket, fase 1A/1B, dosisoptrapning og dosisudvidelsesundersøgelse, der undersøger sikkerheden, farmakokinetikken, farmakodynamikken og antitumoraktiviteten af ​​PHST001 hos voksne patienter med avanceret tilbagefaldt og/eller ildfast faste tumorer

This is a multi-center, first-in-human (FIH), open-label, Phase 1a/1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with anticancer therapies (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). Phase 1b will include the following cohorts 1) tumor-specific cohorts for participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma, 2) a randomized cohort for participants with ovarian cancer who will receive PHST001 in combination with mirvetuximab soravtansine, 3) a cohort for participants with advanced/metastatic breast cancer who will receive PHST001 in combination with trastuzumab deruxtecan and 4) a cohort of patients who consent to additional biomarker studies.

The study's primary objectives are to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 as monotherapy and in combination with anticancer therapies, as well as to assess the anti-tumor activity of PHST001 in combination with anticancer therapies in Phase 1b.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
426

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.
  • Navn: Raphaël Rousseau, Chief Medical Officer, PhD, MD
  • Telefonnummer: 650-260-8443
  • E-mail: medical@pheast.com

Studiesteder

  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater, 90212
      • Los Angeles, California, Forenede Stater, 90033
      • Palo Alto, California, Forenede Stater, 94304
        • Rekruttering
        • Stanford University School of Medicine
        • Kontakt:
        • Ledende efterforsker:
          • Oliver Dorigo, MD, PhD
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Rekruttering
        • Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One
        • Kontakt:
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Rekruttering
        • Yale Cancer Center
        • Ledende efterforsker:
          • Michael Cecchini, MD
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Rekruttering
        • University of Chicago Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Rekruttering
        • University of Michigan Rogel Cancer Center
        • Ledende efterforsker:
          • Ulka Vaishampayan, MD
        • Kontakt:
      • Grand Rapids, Michigan, Forenede Stater, 49546
        • Rekruttering
        • START Center for Cancer Research - Midwest
        • Ledende efterforsker:
          • Sreenivasa Chandana, MD, PhD
        • Kontakt:
    • New York
      • Lake Success, New York, Forenede Stater, 11042
        • Rekruttering
        • START Center for Cancer Research - Long Island New York
        • Ledende efterforsker:
          • Geraldine O'Sullivan Coyne, MD
        • Kontakt:
      • New York, New York, Forenede Stater, 10029
        • Rekruttering
        • Mount Sinai
        • Ledende efterforsker:
          • Thomas Marron, MD, PhD
        • Kontakt:
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Rekruttering
        • Vanderbilt-Ingram Cancer Center
        • Kontakt:
          • Clinical Trials Office (CTO)
          • Telefonnummer: 1-800-811-8480
          • E-mail: cip@vumc.org
        • Ledende efterforsker:
          • Elizabeth Davis, MD, PhD
      • Nashville, Tennessee, Forenede Stater, 37203
        • Rekruttering
        • Sarah Cannon Research Institute (SCRI) Oncology Partners
        • Ledende efterforsker:
          • Deepak Bhamidipati, MD
        • Kontakt:
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Rekruttering
        • START Center for Cancer Research - Texas
        • Kontakt:
        • Ledende efterforsker:
          • Henry Xiong, MD, PhD
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • MD Anderson Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Stéphane Champiat, MD, PhD
      • Irving, Texas, Forenede Stater, 75039
        • Rekruttering
        • NEXT Oncology - Dallas
        • Ledende efterforsker:
          • Michael Song, MD, PhD, PharmD
        • Kontakt:
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • University of Texas (UT) Health
        • Ledende efterforsker:
          • Daruka Mahadevan, MD, PhD
        • Kontakt:
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • START Center for Cancer Research - San Antonio
        • Ledende efterforsker:
          • Kyriakos Papadopoulos, MD
        • Kontakt:
    • Virginia

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

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

Key Inclusion Criteria:

  • Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.
  • Adequate organ function per laboratory testing
  • Pregnancy prevention requirements
  • Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator/radiology
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale

Key Exclusion Criteria:

  • Diagnosis of immunodeficiency
  • History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 2 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, low grade neoplasms, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.
  • Active known CNS metastases and/or carcinomatous meningitis from a systemic (non-CNS) primary malignancy. Participants with previously treated CNS metastases are eligible, provided they are radiologically and clinically stable (i.e., no evidence of progression for at least 2 weeks by repeat imaging performed during screening) and are not requiring systemic corticosteroids above the physiologic replacement for at least 7 days prior to the first dose of study treatment.
  • Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
  • Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.
  • Received previous treatment with another agent targeting CD24.

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: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: PHST001 Monotherapy

Participants will receive PHST001 monotherapy administered once every 3 weeks (Q3W). In Phase 1a, PHST001 will be evaluated in sequential dose-escalation cohorts at planned dose levels of 0.1, 0.3, 1.0, 2.0, 4.0, 6.0, 9.0, 18.0, and 36.0 mg/kg. Dose levels may be modified or additional dose levels evaluated based on emerging safety, pharmacokinetic, pharmacodynamic, and antitumor activity data. Participants in the Phase 1b biomarker cohort may also receive PHST001 monotherapy.
Biologisk: PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.
Eksperimentel: PHST001 + Paclitaxel

Participants will receive PHST001 in combination with paclitaxel. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in tumor-specific expansion cohorts, including participants with ovarian carcinoma, endometrial carcinoma, or cholangiocarcinoma, and/or in the biomarker cohort.
Biologisk: PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

Medicin: Paclitaxel

Paclitaxel used as per standard of care.

Andre navne:
  • Taxol
Eksperimentel: PHST001 + Topotecan

Participants will receive PHST001 in combination with topotecan. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in the ovarian carcinoma expansion cohort and/or biomarker cohort.
Biologisk: PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

Medicin: Topotecan

Topotecan used as per standard of care.

Andre navne:
  • Hycamtin
Eksperimentel: PHST001 + Doxorubicin

Participants will receive PHST001 in combination with doxorubicin. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in ovarian carcinoma or endometrial carcinoma expansion cohorts and/or the biomarker cohort.
Biologisk: PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

Medicin: Doxorubicin

Doxorubicin used as per standard of care.

Andre navne:
  • Adriamycin
Eksperimentel: PHST001 + FOLFIRI

Participants will receive PHST001 in combination with FOLFIRI (5-fluorouracil, folinic acid, and irinotecan). The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in the cholangiocarcinoma expansion cohort and/or biomarker cohort.
Biologisk: PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

Medicin: FOLFIRI

FOLFIRI used as per standard of care.

Andre navne:
  • folinic acid (leucovorin), fluorouracil (5-FU), and irinotecan combination
Eksperimentel: PHST001 + FOLFOX

Participants will receive PHST001 in combination with FOLFOX (5-fluorouracil, folinic acid, and oxaliplatin). The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in the cholangiocarcinoma expansion cohort and/or biomarker cohort.
Biologisk: PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

Medicin: FOLFOX

FOLFOX used as per standard of care.

Andre navne:
  • folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin combination
Eksperimentel: PHST001 + Gemcitabine

Participants will receive PHST001 in combination with gemcitabine. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in ovarian carcinoma or cholangiocarcinoma expansion cohorts and/or the biomarker cohort.
Biologisk: PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

Medicin: Gemcitabine

Gemcitabine used as per standard of care.

Andre navne:
  • Gemzar
Eksperimentel: PHST001 + Mirvetuximab Soravtansine

Participants will receive PHST001 in combination with mirvetuximab soravtansine. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in the ovarian carcinoma expansion cohort and/or in the biomarker cohort. Half of the participants in the randomized ovarian carcinoma cohort may be randomly assigned to receive PHST001 in combination with mirvetuximab soravtansine.
Biologisk: PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

Biologisk: Mirvetuximab Soravtansine

Mirvetuximab soravtansine used as per standard of care.

Andre navne:
  • MIRV, Elahere
Eksperimentel: PHST001 + Trastuzumab Deruxtecan

Participants will receive PHST001 in combination with trastuzumab deruxtecan. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in participants with advanced or metastatic breast cancer and/or in the biomarker cohort.
Biologisk: PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

Biologisk: Trastuzumab Deruxtecan

Trastuzumab deruxtecan used as per standard of care.

Andre navne:
  • T-DXd, Enhertu
Aktiv komparator: Mirvetuximab Soravtansine Monotherapy

Participants with ovarian carcinoma enrolled in the randomized Phase 1b expansion cohort will be randomized 1:1 to receive mirvetuximab soravtansine monotherapy or mirvetuximab soravtansine in combination with PHST001. Participants assigned to this arm will receive mirvetuximab soravtansine monotherapy.
Biologisk: Mirvetuximab Soravtansine

Mirvetuximab soravtansine used as per standard of care.

Andre navne:
  • MIRV, Elahere

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of Dose-Limiting Toxicities (DLTs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From first dose of PHST001 through 21 days after the first dose of PHST001

Based on toxicities observed
From first dose of PHST001 through 21 days after the first dose of PHST001
Frequency of Serious Adverse Events (SAEs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From signed consent up to 90 days after the last dose of PHST001

Based on toxicities observed
From signed consent up to 90 days after the last dose of PHST001
Frequency of Treatment Emergent Adverse Events (TEAEs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From first dose up to 90 days after the last dose of PHST001

Based on toxicities observed
From first dose up to 90 days after the last dose of PHST001
Frequency of Treatment Related Adverse Events (TRAEs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From first dose up to 90 days after the last dose of PHST001

Based on toxicities observed
From first dose up to 90 days after the last dose of PHST001
Frequency of Adverse Events of Special Interest (AESIs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From first dose up to 90 days after the last dose of PHST001

Based on toxicities observed
From first dose up to 90 days after the last dose of PHST001
Frequency of AEs Leading to Dose Interruption or Treatment Discontinuation and AEs Leading to Death to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From first dose up to 90 days after the last dose of PHST001

Based on toxicities observed
From first dose up to 90 days after the last dose of PHST001
Overall Response Rate (ORR) based on RECIST v1.1 to assess the preliminary antitumor activity of PHST001 in combination with anticancer therapy (Phase 1b non-randomized cohorts only)
Tidsramme: From screening and during treatment up to 2 years

Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥ 4 weeks after initial documentation of response.
From screening and during treatment up to 2 years
Progression-Free Survival (PFS) based on RECIST v1.1 to assess the preliminary antitumor activity of PHST001 in combination with anticancer therapy (Phase 1b randomized cohort only)
Tidsramme: From screening and during treatment up to 2 years

Defined as the time from first dose of PHST001 to first documentation of radiographic disease progression or death, whichever occurs first.
From screening and during treatment up to 2 years

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate (ORR) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b - randomized cohort only)
Tidsramme: From screening and during treatment up to 2 years

Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥ 4 weeks after initial documentation of response.
From screening and during treatment up to 2 years
Duration of Response (DOR) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b)
Tidsramme: From screening and during treatment up to 2 years

Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression.
From screening and during treatment up to 2 years
Best Overall Response (BOR) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b)
Tidsramme: From screening and during treatment up to 2 years

Defined as the best response recorded for a participant across all time-point assessments from the start of treatment until disease progression or end of treatment.
From screening and during treatment up to 2 years
Progression-Free Survival (PFS) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b - non-randomized cohorts only) .
Tidsramme: From screening and during treatment up to 2 years

Defined as the time from first dose of PHST001 to first documentation of radiographic disease progression or death, whichever occurs first.
From screening and during treatment up to 2 years
Overall Survival (OS) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b).
Tidsramme: From screening and during treatment up to 2 years

Defined as the time from first dose of PHST001 to the date of death.
From screening and during treatment up to 2 years
Maximum Observed Concentration (Cmax) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b).
Tidsramme: From treatment until 90 days after last dose of PHST001

Defined as the maximum blood concentration of a dose of PHST001
From treatment until 90 days after last dose of PHST001
Time to Maximum Concentration (tmax) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From treatment until 90 days after last dose of PHST001

Defined as the time required for a dose of PHST001 to reach its maximum blood concentration (Cmax) after administration.
From treatment until 90 days after last dose of PHST001
Concentration at the End of a Dosing Interval (Ctrough) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From treatment until 90 days after last dose of PHST001

Defined as the blood concentration of a dose of PHST001 at the end of the dosing interval (just prior to next drug administration).
From treatment until 90 days after last dose of PHST001
Area Under the Concentration-time Curve (AUC) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From treatment until 90 days after last dose of PHST001

Defined as the total PHST001 exposure over time, calculated as the integral of the plasma concentration-time profile.
From treatment until 90 days after last dose of PHST001
Volume of Distribution at Steady-state (Vss) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From treatment until 90 days after last dose of PHST001

Defined as how widely PHST001 spreads throughout the body once things have stabilized after a dose has been administered.
From treatment until 90 days after last dose of PHST001
Clearance (CL) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From treatment until 90 days after last dose of PHST001

Defined as the rate at which the body "cleans out" a dose of PHST001 from the bloodstream.
From treatment until 90 days after last dose of PHST001
Terminal Elimination Half-life (t½) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)
Tidsramme: From treatment until 90 days after last dose of PHST001

Defined as the time it takes for the amount of PHST001 in the body to drop by half during the final phase of elimination.
From treatment until 90 days after last dose of PHST001

Samarbejdspartnere og efterforskere

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

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Pheast Therapeutics

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)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
31. marts 2025

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. april 2029

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. april 2031

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
10. februar 2025

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
18. februar 2025

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
21. februar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
30. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • PHST001-101

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 .

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