RecruitingRecruiting
A Study of IDP-001 in Advanced or Metastatic Solid Tumors
NCT07602842 · InduPro, Inc.
In plain English
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Official title
A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors
About this study
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).
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.
Study design
Enrollment target: 132 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-08
Estimated completion: 2028-12
Last updated: 2026-09-03
Interventions
Drug: IDP-001
Primary outcomes
- • Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1 (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 (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 (Approximately 6 months)
Sponsor
InduPro, Inc. · industry
Contacts & investigators
ContactInduPro Inc. · contact · clinicaltrials@induprotx.com · 617-798-1770
All locations (6)
START Los AngelesRecruiting
Los Angeles, California, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Community Cancer Center NorthRecruiting
Indianapolis, Indiana, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
START New York Long IslandRecruiting
Lake Success, New York, United States
START Dallas Forth WorthRecruiting
Fort Worth, Texas, United States