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A Study of IDP-001 in Advanced or Metastatic Solid Tumors

19. maj 2026 opdateret af: InduPro, Inc.

A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors

This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

132

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

Studiesteder

    • New Jersey
      • Edison, New Jersey, Forenede Stater, 08837
        • Hackensack Meridian - John Theurer Cancer Center
        • Kontakt:

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:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options
  • Satisfy requirements for prior treatments per tumor type as outlined in the protocol
  • Measurable disease per RECIST v1.1
  • Participant willing to provide tumor biopsies
  • Adequate organ function
  • Agree to contraception requirements as outlined in the protocol
  • Life expectancy greater than 12 weeks

Exclusion Criteria:

  • Any clinically significant cardiac disease
  • Any clinically significant corneal disorder
  • Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.
  • Active significant neurologic disorders
  • Requires home oxygen
  • Active autoimmune disease
  • History or active skin disease requiring frequent treatment
  • History of major immunologic reaction to prior immunoglobulin G-containing agent
  • Clinically significant ascites or liver disease
  • Uncontrolled diabetes or diabetic neuropathy
  • Active bleeding disorders
  • Participation in a concurrent clinical study in the treatment period
  • Pregnant or lactating or planning to become pregnant
  • Known hypersensitivity to IDP-001 or any of its ingredients
  • Unresolved toxicities from previous anticancer therapy
  • Has had a seizure prior to Screening
  • Prior solid organ transplant or allogeneic stem cell transplant
  • Current endocrinopathy
  • History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis
  • History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids
  • Stroke or transient ischemic attack prior to Screening
  • Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.

Note: Other inclusion and exclusion criteria may apply.

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 Part 1 Dose Escalation
Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion.
IV infusion
Eksperimentel: Phase 1 Part 2 Indication Selection
Participants with a single tumor indication will receive IDP-001 as IV infusion
IV infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1
Tidsramme: 3 weeks
3 weeks
Phase 1 Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1 Part 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator
Tidsramme: Approximately 6 months
Approximately 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Area Under the Concentration Time Curve (AUC) of IDP-001
Tidsramme: Approximately 6 months
Approximately 6 months
Maximum Observed Plasma Concentration (Cmax) of IDP-001
Tidsramme: Approximately 6 months
Approximately 6 months
Number of Participants with Anti-drug Antibodies (ADAs) in Blood
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1 Part 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator
Tidsramme: Approximately 6 months
Approximately 6 months
Phase 1 Part 2: Overall Survival (OS)
Tidsramme: Approximately 18 months
Approximately 18 months

Samarbejdspartnere og efterforskere

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

Sponsor

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. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

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

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 .

Kliniske forsøg med Avanceret solid tumor

Kliniske forsøg med IDP-001

Abonner