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Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1 Part 1 Dose Escalation 		Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion.
  • Drug: IDP-001
    IV infusion
Experimental
Phase 1 Part 2 Indication Selection 		Participants with a single tumor indication will receive IDP-001 as IV infusion
  • Drug: IDP-001
    IV infusion

Recruiting Locations

START Los Angeles
Los Angeles, California 90025
Contact:
hopeteam@startresearch.com

START New York Long Island
Lake Success, New York 11042
Contact:
hopeteam@startresearch.com

START Dallas Forth Worth
Fort Worth, Texas 76104
Contact:
hopeteam@startresearch.com

More Details

Status
Recruiting
Sponsor
InduPro, Inc.

Study Contact

InduPro Inc.
617-798-1770
clinicaltrials@induprotx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.