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Recruiting NCT07602842

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

Phase I / Phase II Interventional Advanced Solid Tumor Metastatic Solid Tumor Head and Neck Squamous Cell Carcinoma Cutaneous Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IDP-001.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Metastatic Solid Tumor, Head and Neck Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug IDP-001
    IV infusion

Primary outcome measures

  • Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1 [Time frame: 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 [Time frame: 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 [Time frame: Approximately 6 months]
  • Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator [Time frame: Approximately 6 months]
Secondary outcome measures (10)
  • Area Under the Concentration Time Curve (AUC) of IDP-001 [Time frame: Approximately 6 months]
  • Maximum Observed Plasma Concentration (Cmax) of IDP-001 [Time frame: Approximately 6 months]
  • Number of Participants with Anti-drug Antibodies (ADAs) in Blood [Time frame: Approximately 6 months]
  • Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator [Time frame: Approximately 6 months]
  • Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator [Time frame: 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 [Time frame: Approximately 6 months]
  • Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator [Time frame: Approximately 6 months]
  • Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator [Time frame: Approximately 6 months]
  • Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator [Time frame: Approximately 6 months]
  • Phase 1 Part 2: Overall Survival (OS) [Time frame: Approximately 18 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • 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

Identifiers

NCT: NCT07602842 · IDP-001-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗