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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат IDP-001
  IV infusion

Первичные конечные точки

• Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Approximately 6 months]
• Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator [Срок оценки: Approximately 6 months]

Вторичные конечные точки (10)

• Area Under the Concentration Time Curve (AUC) of IDP-001 [Срок оценки: Approximately 6 months]
• Maximum Observed Plasma Concentration (Cmax) of IDP-001 [Срок оценки: Approximately 6 months]
• Number of Participants with Anti-drug Antibodies (ADAs) in Blood [Срок оценки: Approximately 6 months]
• Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator [Срок оценки: Approximately 6 months]
• Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator [Срок оценки: 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 [Срок оценки: Approximately 6 months]
• Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator [Срок оценки: Approximately 6 months]
• Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator [Срок оценки: Approximately 6 months]
• Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator [Срок оценки: Approximately 6 months]
• Phase 1 Part 2: Overall Survival (OS) [Срок оценки: Approximately 18 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• START Los Angeles — Los Angeles
• Hackensack Meridian - John Theurer Cancer Center — Edison
• START New York Long Island — Lake Success
• START Dallas Forth Worth — Fort Worth

Идентификаторы

NCT: NCT07602842 · IDP-001-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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