Advanced Solid Tumor, Cutaneous Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Metastatic Solid Tumor, Non Squamous Non Small Cell Lung Cancer, Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Anus, Squamous Cell Carcinoma of the Cervix, Squamous Cell Carcinoma of the Esophagus
Conditions
Keywords
NSCLC, Squamous NSCLC
Brief summary
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
DRUGIDP-001
IV infusion
Sponsors
InduPro, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator | Approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Concentration Time Curve (AUC) of IDP-001 | Approximately 6 months |
| Maximum Observed Plasma Concentration (Cmax) of IDP-001 | Approximately 6 months |
| Number of Participants with Anti-drug Antibodies (ADAs) in Blood | Approximately 6 months |
| Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator | Approximately 6 months |
| Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator | 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 | Approximately 6 months |
| Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator | Approximately 6 months |
| Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator | Approximately 6 months |
| Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator | Approximately 6 months |
| Phase 1 Part 2: Overall Survival (OS) | Approximately 18 months |
Countries
United States
Contacts
CONTACTInduPro Inc.
Outcome results
None listed