Trials / Recruiting
RecruitingNCT06598371
A Phase 1/2 Study of KSQ-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 141 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1 is to find the recommended dose of KSQ-004EX to give to participants with advanced solid tumors. Phase 2 is to learn if KSQ-004EX at the recommended dose found in Phase1 can help to control advanced solid tumors. The safety and effects of KSQ-004EX will also be studied in both phases.
Detailed description
Phase 1: Dose Escalation Primary Objective: * To evaluate the safety and tolerability of KSQ-004EX in adult participants with advanced solid tumors (melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer) Secondary Objectives * Determine expansion dose * Assess the safety and tolerability of KSQ-004EX in participants with advanced solid tumors (melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer) * Evaluate preliminary anti-tumor activity of KSQ-004EX in participants with advanced solid tumors * Evaluate the feasibility of the manufacturing process Phase 2: Expansion Primary Objective * To assess the anti-tumor activity of KSQ-004EX in participants with advanced malignant solid tumors Secondary Objectives * Assess the safety and tolerability of KSQ-004EX in participants with advanced solid tumors (melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer) * Evaluate anti-tumor activity of KSQ-004EX in participants with advanced malignant solid tumors * Evaluate overall survival (OS) * Evaluate the feasibility of the manufacturing process
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclophosphamide | Given by IV |
| DRUG | Fludarabine | Given by IV |
| DRUG | KSQ-004EX | Given by IV |
| DRUG | Interleukin-2 | Given by IV |
Timeline
- Start date
- 2024-11-21
- Primary completion
- 2039-08-01
- Completion
- 2041-08-01
- First posted
- 2024-09-19
- Last updated
- 2026-04-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06598371. Inclusion in this directory is not an endorsement.