Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Part 1 Dose Escalation | Experimental | Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion. |
|
| Phase 1 Part 2 Indication Selection | Experimental | Participants with a single tumor indication will receive IDP-001 as IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-001 | Drug | IV infusion |
|
| Measure | Description | 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 |
| Measure | Description | 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| InduPro Inc. | Contact | 617-798-1770 | clinicaltrials@induprotx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack Meridian - John Theurer Cancer Center | Edison | New Jersey | 08837 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D001005 | Anus Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided