- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07602842
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
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
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
- Navn: InduPro Inc.
- Telefonnummer: 617-798-1770
- E-mail: clinicaltrials@induprotx.com
Studiesteder
-
-
New Jersey
-
Edison, New Jersey, Forenede Stater, 08837
- Hackensack Meridian - John Theurer Cancer Center
-
Kontakt:
- Miguel Gonzalez Velez, M.D.
- Telefonnummer: 480-232-2015
- E-mail: clinicaltrials@induprotx.com
-
-
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
|
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Eksperimentel: Phase 1 Part 2 Indication Selection
Participants with a single tumor indication will receive IDP-001 as IV infusion
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IV infusion
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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
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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
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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
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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
|
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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
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer efter sted
- Neoplasmer
- Tarmsygdomme
- Neoplasmer efter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Kolorektale neoplasmer
- Intestinale neoplasmer
- Endetarmssygdomme
- Neoplasmer i hoved og hals
- Neoplasmer, kirtel og epitel
- Neoplastiske processer
- Esophageale sygdomme
- Karcinom
- Neoplasmer, pladecelle
- Esophageale neoplasmer
- Anus sygdomme
- Rektale neoplasmer
- Patologiske tilstande, tegn og symptomer
- Planocellulært karcinom i hoved og hals
- Esophageal pladecellekarcinom
- Karcinom, pladecelle
- Neoplasma Metastase
- Anus neoplasmer
Andre undersøgelses-id-numre
- IDP-001-101
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
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Novartis PharmaceuticalsAfsluttetcMET Dysegulation Advanced Solid TumorsØstrig, Danmark, Sverige, Det Forenede Kongerige, Spanien, Tyskland, Holland, Forenede Stater
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Shanghai Qilu Pharmaceutical Research and Development...Ikke rekrutterer endnuMSI-H eller dMMR Advanced Solid Tumors
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRekrutteringKRAS G12C Mutant Advanced Solid TumorsKina
-
D3 Bio (Wuxi) Co., LtdRekrutteringHER-2 Positive Advanced Solid TumorsAustralien, Forenede Stater, Kina
-
AmgenAktiv, ikke rekrutterendeKRAS p.G12C Mutant Advanced Solid TumorsForenede Stater, Frankrig, Canada, Spanien, Belgien, Østrig, Australien, Ungarn, Grækenland, Japan, Brasilien, Tyskland, Schweiz, Portugal, Rumænien, Sydkorea
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Shanghai Pudong HospitalUTC Therapeutics Inc.Trukket tilbageMesothelin-positive Advanced Refractory Solid TumorsKina
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Krankenhaus NordwestAfsluttetHer2/Neu Positive Advanced Solid TumorsTyskland
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Memorial Sloan Kettering Cancer CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
Kliniske forsøg med IDP-001
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Bausch Health Americas, Inc.AfsluttetAcne VulgarisForenede Stater, Canada
-
IlDong Pharmaceutical Co LtdAfsluttetSund og raskKorea, Republikken
-
Bausch Health Americas, Inc.Afsluttet
-
Bausch Health Americas, Inc.AfsluttetAcne VulgarisForenede Stater, Canada
-
Bausch Health Americas, Inc.AfsluttetAcne VulgarisForenede Stater, Canada
-
Valeant PharmaceuticalsUkendt
-
Dow Pharmaceutical SciencesAfsluttet
-
Bausch Health Americas, Inc.AfsluttetAcne VulgarisForenede Stater, Canada
-
Bausch Health Americas, Inc.AfsluttetAcne VulgarisForenede Stater, Canada
-
Valeant PharmaceuticalsUkendt