A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer (NCT04844073) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer
Stopped: Sponsor decision based on limited anti-cancer activity of TAK-186.
United States95 participantsStarted 2021-03-08
Plain-language summary
The main aim of this study is to check for side effects and tolerability of TAK-186 (also known as MVC-101) in adults with unremovable advanced or metastatic cancer. Another aim is to characterize and evaluate the activity of TAK-186 (MVC-101).
Participants may receive treatment throughout the study for a maximum of 13 months and will be followed up at 30 days and 90 days and then every 12 weeks for up to 48 weeks after the last treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants with salivary gland tumors will not be considered as having HNSCC.
✓. Participants who refuse surgery for potentially curable disease where the surgery or radiotherapy could result in severe morbidity are eligible. The reason for the refusal will be captured in the electronic case report form (eCRFs).
✓. Albumin ≥ 3.0 g/dL
✓. Platelet count ≥ 75 × 103/μL
✓. Hemoglobin ≥ 9.0 g/dL
✓. Absolute neutrophil count ≥ 1.0 × 103/μL
✓. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN); for participants with hepatic metastases, ALT/AST ≤ 5 × ULN
✓. Total bilirubin ≤ 1.5 × ULN, except participants with Gilbert's syndrome, who may enroll if the conjugated bilirubin is within normal limits.
Exclusion criteria
✕. Vitiligo.
What they're measuring
1
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timeframe: From the signing of ICF through 30 days after the last dose of study drug for non immune-related AEs, and through 90 days after the last dose of study drug for immune-related AEs (Up to approximately 13 months)
2
Number of Participants with Cytokine Release Syndrome/Infusion Reactions
Timeframe: From the signing of ICF through 30 days after the last dose of study drug (Up to approximately 13 months)
3
Number of Participants with a Dose-Limiting Toxicity (DLT)
Timeframe: DLT Evaluation Period (up to Day 28) in Dose Escalation Phase
. Psoriasis not requiring systemic treatment for \> 1 year before receiving TAK-186.
✕. History of Graves' disease in participants now euthyroid for \> 4 weeks.
✕. Hypothyroidism managed by thyroid replacement.
✕. Alopecia.
✕. Well-controlled diabetes type 1.
✕. Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies: ≤ 2 weeks or 5 half-lives, whichever is shorter.
✕. Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies: ≤ 4 weeks.