BridgeMD
New treatment option for Malignant Solid Tumors
Official title A Study of TAK-505 in Adults With Solid Tumors
ClinicalTrials.gov ID: NCT07436728
What this study is testing
What is TAK-505?
TAK-505 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant solid tumors.
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
- Solid tumors occur when cells in an organ or tissue (for example in the lung or liver) start growing out of control (cancer) and form a lump or mass of cells. These solid cancers may grow very far in the general area where they started (called locally advanced) or may spread to other parts of the body (called metastatic), and doctors may not always be able to completely remove them with surgery (called unresectable).
- Phase 2: a mid-size study of how well it works
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
- Aged greater than or equal to (≥) 18 years or ≥ the local legal age of majority, as applicable, at the time of signing the main informed consent form...
- Criteria for disease state in dose escalation and cohort-expansion:
- Tumor histologies during dose escalation (including potential participants in backfill cohort): Participants with histologically or pathologically...
- Gastric adenocarcinoma.
- Colorectal cancer (CRC).
You likely can't join if
- History of known autoimmune disease, except for: a) Vitiligo. b) Psoriasis not requiring systemic treatment for \>1 year before receipt of TAK-505...
- History of brain metastasis or leptomeningeal disease unless: a) Brain metastases are stable on cranial imaging (that is, ≥4 weeks) following prior...
- History of any of the following ≤6 months before the first dose of trial intervention: a) Congestive heart failure New York Heart Association (NYHA)...
- History of hepatic encephalopathy.
- Active diagnosis of a lung condition including: a) Pneumonitis b) Interstitial lung disease c) Severe chronic obstructive pulmonary disease d)...
- Ongoing or active infection of Grade ≥2
See the full eligibility criteria
Who can join
- Aged greater than or equal to (≥) 18 years or ≥ the local legal age of majority, as applicable, at the time of signing the main informed consent form (ICF).
- Criteria for disease state in dose escalation and cohort-expansion:
- Tumor histologies during dose escalation (including potential participants in backfill cohort): Participants with histologically or pathologically confirmed locally advanced or metastatic solid tumors, who are either...
- Gastric adenocarcinoma.
- Colorectal cancer (CRC).
- Non-small cell lung cancer (NSCLC) (both squamous and non-squamous).
- Head and neck squamous cell carcinoma (HNSCC). b) Tumor histologies during dose expansion: Participants will be eligible if they have histologically or pathologically confirmed, locally advanced or metastatic solid...
- Participants with no known activating mutations: have received platinum-based chemotherapy and anti-programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) for locally advanced or metastatic disease...
- Participants with a known activating mutation with an approved and accessible target therapy (including but not limited to epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase, ROS proto-oncogene 1...
- Participants should have received no more than 3 prior lines of therapies for locally advanced or metastatic cancer. 2\. CRC: adenocarcinoma
- Participants who have received or been intolerant to treatment with either trifluridine/tipiracil (TAS-102), regorafenib or fruquintinib. Participants who have been treated with all are permitted. Participants must also...
- Participants should have received no more than 4 prior lines of therapies for locally advanced or metastatic cancer. 3\. Gastric adenocarcinoma
- Participants who have received or been intolerant to platinum/fluoropyrimidine doublet with or without anthracycline. Participants who are human epidermal growth factor receptor 2 (HER2) positive, PD-L1 positive or...
- Participants should have received no more than 3 prior lines of therapies for locally advanced or metastatic cancer. 3\. Confirmed PD-L1 positive by an FDA approved, Conformité Européene (CE)-marked, or other...
- Absolute neutrophil count (ANC) ≥1,000/ microliters(μL),
- Platelet count ≥75,000/μL
- Hemoglobin ≥9.0 grams per deciliter (g/dL). 8. Adequate renal and liver function as defined below:
- Alanine aminotransferase (ALT)/ Aspartate aminotransferase (AST) less than equal to (≤) 3.0 × the upper limit of the normal range (ULN); for participants with hepatic metastases, ALT and AST)≤5 × ULN.
- Total bilirubin ≤1.5 × ULN, except for participants with Gilbert's syndrome, who may be enrolled if the conjugated bilirubin is within normal limits.
- Creatinine clearance ≥45 mL/minute (calculated by Cockcroft-Gault formula). 9. Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per National Cancer Institute [NCI] Common Terminology...
What rules you out
- History of known autoimmune disease, except for: a) Vitiligo. b) Psoriasis not requiring systemic treatment for \>1 year before receipt of TAK-505. c) History of Graves' disease in participants now euthyroid for \>4...
- History of brain metastasis or leptomeningeal disease unless: a) Brain metastases are stable on cranial imaging (that is, ≥4 weeks) following prior surgery, whole-brain radiation OR b) Received stereotactic radiosurgery...
- History of any of the following ≤6 months before the first dose of trial intervention: a) Congestive heart failure New York Heart Association (NYHA) Grade III or IV. b) Unstable angina. c) Myocardial infarction. d)...
- History of hepatic encephalopathy.
- Active diagnosis of a lung condition including: a) Pneumonitis b) Interstitial lung disease c) Severe chronic obstructive pulmonary disease d) Idiopathic pulmonary fibrosis e) Other restrictive lung diseases f) Acute...
- Ongoing or active infection of Grade ≥2
- Oxygen saturation \<90% on room air at screening or during the C1D1 predose assessment.
- Inflammatory process that has not resolved for ≥4 weeks before the first dose of trial intervention. Participants with chronic low-grade inflammatory processes such as radiation induced pneumonitis are excluded...
- Clinically significant gastrointestinal disorders including the following:
- Gastrointestinal perforation or unhealed ulcerations \<6 months before trial intervention administration. Participants must have documented evidence (for example, upper endoscopy or colonoscopy) of a completely healed...
- Gastrointestinal bleeding \<2 months before trial intervention administration. Participants must have documented evidence (for example, from upper endoscopy or colonoscopy) of a completely healed area of prior bleeding.
- Pancreatitis \ 4 weeks before the initiation of trial intervention.
- Diverticulitis flare \<2 months before trial intervention administration. Participants must have a CT scan demonstrating no evidence of remaining disease before the initiation of trial intervention.
- History of Crohn's disease or ulcerative colitis.
- Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of trial intervention. Inactivated annual influenza vaccination is allowed.
- History of a bone marrow transplantation within the past 5 years or solid organ transplantation (as a recipient) and use of immunosuppressive agents.
- Known hypersensitivity to TAK-505 or any excipient (acetate, arginine, histidine, methionine or polysorbate 80) contained in the drug or diluent formulation, or known hypersensitivity to tocilizumab.
- Diagnosed with a second primary invasive malignancy not in remission for ≥3 years. Exceptions include:
- Nonmelanoma skin cancer
- Cervical carcinoma in situ
- Resected melanoma in situ
- Malignancies considered indolent and never required therapy. This does not include lymphomas.
- Others upon consultation and approval from the sponsor.
- Known to be Human Immunodeficiency Virus (HIV) positive or hepatitis B or C positive as defined below:
- Positive serology for HIV.
- Positive hepatitis B surface antigen (HBsAg) test.
- Positive hepatitis C virus (HCV) antibody test.
- Received the following prior therapies before the planned start of TAK-505:
- Cytotoxic chemotherapy, small-molecule inhibitors, cell therapy, radiation, treatment radiology procedure, or similar investigational therapies within ≤2 weeks or 5 half-lives, whichever is shorter.
- Monoclonal antibodies including PD-1 checkpoint inhibitors (for example, pembrolizumab and nivolumab), antibody (Ab)-drug conjugates, radioimmunoconjugates, or similar therapies within ≤4 weeks.
- Any anti-PD-L1 treatment, including PD-L1 checkpoint inhibitors (for example, atezolizumab and durvalumab) and antibody-drug conjugates, within 120 days.
- Not recovered to Grade 1 or baseline or established as sequelae from all toxic effects of previous therapy (except alopecia, neuropathy, or autoimmune endocrinopathies with stable endocrine replacement therapy, or bone...
- Used corticosteroids or other immunosuppressive medication, concurrently or within 14 days of administration of TAK-505, except for: a) Topical, intranasal, inhaled, ocular, or intra-articular corticosteroids. b)...
- Major surgery or traumatic injury within 8 weeks before the first dose of trial intervention.
- Unhealed wounds from surgery or injury.
- Any pre-existing medical or psychiatric condition or illness, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would...
- Has a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before the first dose of trial intervention.
- Is capable of breastfeeding but does not agree to forego breastfeeding from the first dose of trial intervention through 180 days after the last dose of trial intervention.
- Is a person of child-bearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception (preferably male condom) until 180 days after the last...
- Is of male birth and fertile, and has partners of childbearing potential, but does not agree to use effective barrier contraception, that is, a condom, combined with at least 1 other form of acceptable contraception...
- Does not agree to refrain from donating gametes from signing of the main ICF until 180 days after the last dose of trial intervention.
- Is a trial site employee, a site employee's immediate family member (for example, spouse, parent, child, and sibling), or is in a dependent relationship with a trial site employee who is involved in the conduct of this...
- Is considered to be vulnerable, as defined per local regulations and if exclusion is required by local regulations. Examples are persons under safeguard of justice, persons deprived of liberty by judicial or...
- Is unable or unwilling to comply with clinic visits and procedures outlined in the trial protocol.
- Is unwilling to provide informed consent/age-appropriate assent.
- Baseline prolongation of the QT interval with Fridericia correction method (QTcF) (for example, repeated demonstration of corrected QT interval [QTc] ≥480 ms, history of congenital long QT syndrome, or torsades de...
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Tampa, Florida, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Orange, California, United States; San Diego, California, United States; San Francisco, California, United States; Tampa, Florida, United States; Minneapolis, Minnesota, United States; New York, New York, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.