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New treatment option for Solid Tumor
Official title FORTRAS: A Study of MSK-TCR5 in People With Solid Tumor Cancers
ClinicalTrials.gov ID: NCT07638371
What this study is testing
What is MSK-TCR5?
MSK-TCR5 is an investigational medicine, being studied as a potential treatment for solid tumor.
Also referred to as Modified T-calls.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to test the safety of MSK-TCR5 in participants with advance solid tumor cancer that has a KRAS, HRAS, or NRAS G12D mutation.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part A: Prior to cell collection all of the following must be met:
- Age ≥18 years.
- Histologically confirmed advanced or metastatic, unresectable solid tumor
- Positive for RAS G12D mutation and HLA-A\ 11:01 allele
- Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease after at least 1 line of systemic standard of care...
You likely can't join if
- Part A: Participant Exclusion Criteria prior to cell collection
- Previous allogeneic stem cell transplantation or prior organ transplantation
- History of primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus...
- Primary brain tumor
- Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Patients previously treated for CNS...
- Surgery or catheter-based interventions such as transarterial chemoembolization or percutaneous coronary intervention within 2 weeks.
See the full eligibility criteria
- Part A: Prior to cell collection all of the following must be met:
- Age ≥18 years.
- Histologically confirmed advanced or metastatic, unresectable solid tumor
- Positive for RAS G12D mutation and HLA-A\ 11:01 allele
- Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease after at least 1 line of systemic standard of care (SOC) treatment regimen and for which there are no available curative...
- For CRC: Patients harboring genomic aberrations such as BRAFV600E mutations, HER2 amplifications, or VEGF expression for which FDA-approved targeted therapies are available must have received prior treatment with...
- For NSCLC: Patients harboring genomic aberrations such as non-resistant EGFR mutations, ALK rearrangement, ROS rearrangement, and BRAF V600E mutation for which FDA-approved targeted therapies are available must have...
- Any other solid tumors, including PDAC: Patients harboring genomic aberrations for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted...
- Measurable disease per RECIST version 1.1. Note: a previously irradiated or locoregionally treated lesion can be considered a target lesion if it progressed post-treatment.
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function based on the following laboratory values:
- ANC ≥1000/mm3 without granulocyte colony-stimulating factor support (filgrastim within 7 days or peg-filgrastim within 14 days of screening)
- Platelets ≥75,000/mm3 without transfusion within the preceding 7 days of screening.
- Hemoglobin ≥8.0 g/dL (≥80 g/L); blood transfusion permitted within 7 days of screening.
- AST, ALT, and ALP ≤ 3x ULN, or ≤ 5x ULN if liver or bone metastases present.
- Total bilirubin ≤ 1.5x ULN or ≤ 3x ULN in the presence of documented Gilbert's Syndrome
- CrCl ≥50 mL/min by Cockcroft-Gualt equation
- Part A: Participant Exclusion Criteria prior to cell collection
- Previous allogeneic stem cell transplantation or prior organ transplantation
- History of primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease that in the past...
- Primary brain tumor
- Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Patients previously treated for CNS metastases that are radiographically and neurologically stable and off steroids...
- Surgery or catheter-based interventions such as transarterial chemoembolization or percutaneous coronary intervention within 2 weeks.
- Uncontrolled significant intercurrent or recent illness including, but not limited to the following conditions: a. Significant cardiovascular abnormalities as defined by any one of the following: uncontrolled congestive...
- Uncontrolled active bacterial, viral, fungal, or mycobacterial infection not responding to antibiotics, antimycotics, or antifungal agents, as well as long-term oral treatment with any of these agents.
- Subject has had radiotherapy or systemic anti-cancer therapy within at least 2 weeks or 3 half-lives, whichever is shorter.
- Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for...
- Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with LDC or MSK-TCR5.
- Positive serologic test results for HIV.
- Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.
- Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR
- Patient/parent/LAR unable to give informed consent Part B: Participant Exclusion Criteria prior to MSK-TCR5 infusion
- Any exclusion criterion listed in Part A.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.