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XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors

30. juni 2026 opdateret af: Xilio Development, Inc.

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX501 in Participants With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors

This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX501 as monotherapy in participants with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, PK, pharmacodynamics, immunogenicity, and antitumor activity of XTX501, an investigational bispecific PD-1/masked IL-2 in participants with metastatic NSCLC and select advanced solid tumors.

Phase 1, Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens.

Phase 1, Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s).

Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

140

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiekontakt

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Measurable disease at baseline per RECIST v1.1
  • ECOG performance status of 0 or 1
  • Adequate organ function

  • Metastatic NSCLC:

    • Must have histologically confirmed metastatic NSCLC.
    • Tumor must have been assessed for EGFR and ALK per local standard of practice; patients with these driver mutations are excluded.
    • Patients with tumors known to have the following alterations are excluded: ROS1, RET, MET, HER-2, NTRK 1/2/3.
    • Patients must have previously derived clinical benefit from a PD-1/PD-L1 inhibitor or PD-1/PDL-1 bispecific without progression for at least 6 months.

Exclusion Criteria:

  • Prior treatment with IL-2
  • History of significant pulmonary disease
  • History of clinically significant cardiovascular disease
  • Active CNS metastases
  • Pregnant or breastfeeding

In Phase 1, participants with select additional solid tumor types may be enrolled.

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: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phase 1 - XTX501 Monotherapy Dose Escalation and Backfill

Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens.

Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s).
Medicin: XTX501
XTX501 monotherapy
Eksperimentel: Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLC
Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s) in participants with metastatic NSCLC.
Medicin: XTX501
XTX501 monotherapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of Dose Limiting Toxicities (DLTs) in Part 1A
Tidsramme: Cycle 1 Day 1 up to just prior to the second dose of study drug (approximately 21 days)
Cycle 1 Day 1 up to just prior to the second dose of study drug (approximately 21 days)
Incidence of treatment-emergent adverse events (Phase 1 and Phase 2)
Tidsramme: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Up to Safety Follow Up Period (90 [+7] days after the last dose)
Incidence of serious adverse events (Phase 1 and Phase 2)
Tidsramme: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Up to Safety Follow Up Period (90 [+7] days after the last dose)
Incidence of significant change from baseline in clinical laboratory values (Phase 1 and Phase 2)
Tidsramme: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Up to Safety Follow Up Period (90 [+7] days after the last dose)
Investigator-assessed objective response rate (ORR) per RECIST v1.1 (Phase 2)
Tidsramme: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Up to Safety Follow Up Period (90 [+7] days after the last dose)

Sekundære resultatmål

Resultatmål
Tidsramme
Investigator-assessed objective response rate (ORR) per RECIST v1.1 (Phase 1)
Tidsramme: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Up to Safety Follow Up Period (90 [+7] days after the last dose)
Investigator-assessed duration of response (DOR) per RECIST v1.1 (Phase 1 and Phase 2)
Tidsramme: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Up to Safety Follow Up Period (90 [+7] days after the last dose)
Investigator-assessed disease control rate (DCR) per RECIST v1.1 (Phase 2)
Tidsramme: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Up to Safety Follow Up Period (90 [+7] days after the last dose)
Investigator-assessed progression free survival (PFS) per RECIST v1.1 (Phase 2)
Tidsramme: Up to Safety Follow Up Period (90 [+7] days after the last dose)
Up to Safety Follow Up Period (90 [+7] days after the last dose)
Incidence and persistence of antidrug antibodies (ADAs) (Phase 1 and Phase 2)
Tidsramme: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Maximum observed plasma concentration (Cmax) (Phase 1 and Phase 2)
Tidsramme: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Time of maximum observed concentration (Tmax) (Phase 1 and Phase 2)
Tidsramme: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Trough concentrations (Ctrough) (Phase 1 and Phase 2)
Tidsramme: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Area under the curve (AUC) (Phase 1 and Phase 2)
Tidsramme: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Half-life (t1/2) (Phase 1 and Phase 2)
Tidsramme: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Systemic clearance (CL) (Phase 1 and Phase 2)
Tidsramme: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Volume of distribution (Vd) (Phase 1 and Phase 2)
Tidsramme: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)
Up to End of Treatment (within 10 days of the decision to discontinue XTX501)

Samarbejdspartnere og efterforskere

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

Sponsor

Xilio Development, 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 (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. november 2029

Studieafslutning (Anslået)

1. november 2029

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • XTX501-01/02-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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