A Study of IDP-001 in Advanced or Metastatic Solid Tumors
Recruiting
Phase 1Phase 2Interventional Study
Advanced Solid TumorMetastatic Solid TumorHead and Neck Squamous Cell CarcinomaCutaneous Squamous Cell CarcinomaSquamous Cell Carcinoma of the CervixNon Squamous Non Small Cell Lung CancerSquamous Cell Carcinoma of the EsophagusSquamous Cell Carcinoma of the AnusSquamous Cell Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
InduPro, Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Status
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…
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.
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