Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors

30 juni 2026 bijgewerkt door: Relay Therapeutics, Inc.

A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors

This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors. This study consists of 2 parts: dose escalation (Part 1) and dose expansion (Part 2).

Part 1, dose escalation will explore multiple ascending doses of RLY-8161 in participants with any advanced NRAS-mutant solid tumor until maximum tolerated dose is reached or one or more recommended Phase 2 dose (RP2D) is identified.

Part 2, dose expansion will be at the RP2D(s) identified in Part 1 in NRAS-mutant solid tumors.

Studietype

Ingrijpend

Inschrijving (Geschat)

35

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90095
        • Werving
        • University of California, Los Angeles
        • Contact:
      • San Francisco, California, Verenigde Staten, 94143
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Werving
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, Verenigde Staten, 02215
    • Michigan
      • Grand Rapids, Michigan, Verenigde Staten, 49546
    • New York
      • New York, New York, Verenigde Staten, 10065
        • Werving
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Werving
        • Sarah Cannon Research Institute Oncology Partners
        • Contact:
    • Virginia
      • Fairfax, Virginia, Verenigde Staten, 22031

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor.
  • Disease is refractory to standard therapy (including targeted therapy), participant is intolerant of standard therapy, or participant has declined standard therapy.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • One or more documented primary oncogenic NRAS mutation(s).

Exclusion Criteria:

  • Known activating KRAS, HRAS, or BRAF mutation or known alterations in other driver oncogenes.
  • Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway.
  • For participants with melanoma: lactate dehydrogenase (LDH) >2×ULN.
  • Central nervous system (CNS) metastases that are associated with progressive neurologic symptoms or require ongoing corticosteroids to control the CNS disease.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors
Multiple doses of RLY-8161 for oral administration
Geneesmiddel: RLY-8161
RLY-8161 is an NRAS-selective inhibitor
Experimenteel: Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors
Oral doses of RLY-8161 as determined during Part 1 Dose Escalation
Geneesmiddel: RLY-8161
RLY-8161 is an NRAS-selective inhibitor

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161
Tijdsspanne: Cycle 1 (28-day cycle) of treatment for MTD and at the end of every cycle (28-day cycle) for RP2D until treatment discontinuation, approximately 12 months
Cycle 1 (28-day cycle) of treatment for MTD and at the end of every cycle (28-day cycle) for RP2D until treatment discontinuation, approximately 12 months
Part 1: Number of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs), with changes in vital signs, electrocardiograms (ECGs), and laboratory tests
Tijdsspanne: Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months
Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months
Part 2: Objective Response Rate (ORR) of RLY-8161 as assessed by RECIST v1.1
Tijdsspanne: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Part 1 and Part 2: Changes in NRAS mutant allele fraction in ctDNA
Tijdsspanne: Approximately every 2 weeks in Cycle 1 (28-day cycle), at the beginning of Cycle 2 (28-day cycle), and at the beginning of every odd cycle (28-day cycle) until End of Treatment (EOT), approximately 12 months
Approximately every 2 weeks in Cycle 1 (28-day cycle), at the beginning of Cycle 2 (28-day cycle), and at the beginning of every odd cycle (28-day cycle) until End of Treatment (EOT), approximately 12 months
Part 1 and Part 2: Plasma concentration and PK parameters of RLY-8161
Tijdsspanne: Approximately every 2 weeks in Cycle 1 (28-day cycle) and at Day 1 of every cycle (28-day cycle) through Cycle 4
Approximately every 2 weeks in Cycle 1 (28-day cycle) and at Day 1 of every cycle (28-day cycle) through Cycle 4
Part 1: ORR of RLY-8161 as assessed by RECIST v1.1
Tijdsspanne: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Part 1 and 2: Duration of Response (DOR) of RLY-8161 as assessed by RECIST v1.1
Tijdsspanne: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Part 1 and 2: Disease Control Rate (DCR) of RLY-8161 as assessed by RECIST v1.1
Tijdsspanne: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Part 2: Progression-free survival (PFS) as assessed by RECIST v1.1
Tijdsspanne: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Part 2: Overall Survival
Tijdsspanne: Cycle 1 (28-day cycles) until study completion, approximately 30 months
Cycle 1 (28-day cycles) until study completion, approximately 30 months
Part 2: Number of participants with AEs or SAEs, with changes in vital signs, ECGs, and laboratory tests
Tijdsspanne: Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months
Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Relay Therapeutics, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 maart 2026

Primaire voltooiing (Geschat)

30 december 2027

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

28 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

13 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

30 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • RLY-8161-101

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren