A Study of IDP-001 in Advanced or Metastatic Solid Tumors
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
- Advanced Solid Tumor
- Metastatic Solid Tumor
- Head and Neck Squamous Cell Carcinoma
- Cutaneous Squamous Cell Carcinoma
- Squamous Cell Carcinoma of the Cervix
- Non Squamous Non Small Cell Lung Cancer
- Squamous Cell Carcinoma of the Esophagus
- Squamous Cell Carcinoma of the Anus
- Squamous Cell Carcinoma
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1 Part 1 Dose Escalation |
Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion. |
|
|
Experimental Phase 1 Part 2 Indication Selection |
Participants with a single tumor indication will receive IDP-001 as IV infusion |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- InduPro, Inc.