Clinical trial · Interventional
A Study of IDP-001 in Advanced or Metastatic Solid Tumors
A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors
NCT07602842CI-TRIAL-00125659recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Non Squamous Non Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of the Anus | Anal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Cervix | Cervical Squamous Cell Carcinoma | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IDP-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 Part 1 Dose Escalation
- description
- Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion.
- interventionNames
- Drug: IDP-001
- type
- EXPERIMENTAL
- label
- Phase 1 Part 2 Indication Selection
- description
- Participants with a single tumor indication will receive IDP-001 as IV infusion
- interventionNames
- Drug: IDP-001
Primary outcomes (4)
- measure
- Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.