A phase 2, Multicenter Study of TILs Treatment in Advanced Tumors with Alterations in the SWI/SNF Complex: the TILTS Study

Conditions

Advanced solid tumors

Brief summary

• ORR per RECIST v1.1 as assessed by investigator

Detailed description

• Toxicity evaluation: nature and frequency of Adverse Events (AE), Severe Adverse Events (SAE), Treatment-limiting Toxicity (TLT), alterations in clinical, laboratory test results, ECGs, vital sign measurements, physical examination findings graded, when applicable, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0., • CRR per RECIST v1.1 as assessed by investigator, • DOR per RECIST v1.1 as assessed by investigator, • DCR per RECIST v1.1 as assessed by investigator, • PFS per RECIST v1.1 as assessed by investigator, OS

Juan Martín-Liberal, Elena Garralda, Jesús García-Donás, J.J. Soto Castillo, Alberto Mussetti et al. (20 authors)

Future Oncology2024-08-12

10.1080/14796694.2024.2385287

A phase 2, multicenter study of TILs treatment in advanced tumors with alterations in the SWI/SNF complex: The TILTS study.

Juan Martín-Liberal, Elena Garralda, Jesús García-Donás, Juan Jose Soto, Carles Codony et al. (18 authors)

Journal of Clinical Oncology2024-06-01

10.1200/jco.2024.42.16_suppl.tps2674

Interventions

DRUGPROLEUKIN

DRUG18x106 UI polvo para solución inyectable o para perfusión

DRUGGenoxal 1.000 mg polvo para solución inyectable y para perfusión

DRUGTumor Infiltrating Lymphocytes (TILs)

DRUGFludarabina Teva 25 mg/ml concentrado para solución para perfusión o inyección EFG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• ORR per RECIST v1.1 as assessed by investigator	—

Secondary

Measure	Time frame
• Toxicity evaluation: nature and frequency of Adverse Events (AE), Severe Adverse Events (SAE), Treatment-limiting Toxicity (TLT), alterations in clinical, laboratory test results, ECGs, vital sign measurements, physical examination findings graded, when applicable, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0., • CRR per RECIST v1.1 as assessed by investigator, • DOR per RECIST v1.1 as assessed by investigator, • DCR per RECIST v1.1 as assessed by investigator, • PFS per RECIST v1.1 as assessed by investigator, OS	—

Measure

Time frame

• Toxicity evaluation: nature and frequency of Adverse Events (AE), Severe Adverse Events (SAE), Treatment-limiting Toxicity (TLT), alterations in clinical, laboratory test results, ECGs, vital sign measurements, physical examination findings graded, when applicable, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0., • CRR per RECIST v1.1 as assessed by investigator, • DOR per RECIST v1.1 as assessed by investigator, • DCR per RECIST v1.1 as assessed by investigator, • PFS per RECIST v1.1 as assessed by investigator, OS

—

Countries

Spain

Outcome results

None listed