Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-928 · 1 trial · 1 indication
cORR is defined as the proportion of participants with confirmed objective response rate (complete response \[CR\] or partial response \[PR\]) per RECIST V1.1 CR is defined as complete disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non- target) must have reduction in short axis to less than (\<) 10 mm. PR is defined as at least a 30 percent decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
To compare the overall survival (OS) of TAK-928 (treatment group) versus docetaxel (control group) in participants with unresectable locally advanced or metastatic squamous NSCLC with disease progression on or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
DLT will be defined as any of the adverse events (AEs) specified in the protocol that occur within the DLT observation period, is not attributable to disease or other extraneous factors and potentially related to the intervention following the first dose. Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
AE: Any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not there is a causal relationship with any trial intervention, including, but not limited to, following: Exacerbation of pre-existing medical conditions/diseases (including worsening of symptoms, signs, laboratory abnormalities) temporally associated with the use of trial intervention; any newly developed adverse medical conditions (including symptoms, signs and newly diagnosed diseases) and clinically significant abnormal laboratory values or results. TEAE: Any AE that starts after the first administration of study drug. SAE: Any untoward medical occurrence that meets at least one of the following criteria: Results in death; is life threatening; requires inpatient hospitalization or prolongation of hospitalization. irAEs may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously.
| Arm | Type | Description |
|---|---|---|
| TAK-928 | EXPERIMENTAL | TAK-928 is a first-in-class bispecific monoclonal antibody (mAb) comprised of an interleukin-2 (IL-2) mutein fused with a recombinant anti-programmed cell death protein 1 (anti-PD-1) mAb. TAK-928 was precisely designed and constructed to afford targeted binding of tumor-specific CD8+ T cells (TSTs) that co-express PD-1 and CD25 (IL2Ra) receptors. The mechanism of action of TAK-928 is blocking the PD-(L)1 and activating the IL-2 pathways simultaneously to reverse T cell exhaustion and promote activation of T cells and natural killer (NK) cells, and consequently eliminate tumor cells. |
| Control | ACTIVE_COMPARATOR | Docetaxel or comparable generic brand |
| Name | Type | Description |
|---|---|---|
| TAK-928 | DRUG | TAK-928 will be administered by IV infusion. |
| Control Arm | DRUG | Comparator product will be administered by IV infusion. |
Inclusion Criteria: 1. Must be able to understand and willing to sign the written informed consent form (ICF), be able to comply with the visit schedule and related procedures specified in the protocol. 2. Male or female participants must be at least 18 years old or the legal age of majority in the...
TAK-928 is an investigational small molecule being developed for the treatment of IO-resistant squamous non-small cell lung cancer (sqNSCLC). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
TAK-928 is being developed by Takeda Pharmaceutical Company Limited, which is publicly traded under the ticker symbol TAK. The company is conducting a Phase 3 clinical trial of the drug in patients with IO-resistant squamous non-small cell lung cancer.
TAK-928 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. A Phase 3 trial is currently recruiting participants to evaluate the drug in adults with IO-resistant squamous non-small cell lung cancer.
TAK-928 is being studied in a Phase 3 clinical trial with the identifier NCT07217301. This randomized, active-controlled study compares TAK-928 with docetaxel in adults with IO-resistant squamous non-small cell lung cancer. The trial is recruiting 600 participants in the United States, China, and Japan.
No, TAK-928 is not the same as docetaxel. TAK-928 is an investigational small molecule being studied as a potential treatment for IO-resistant squamous non-small cell lung cancer, while docetaxel is an established chemotherapy drug used as the active comparator in the Phase 3 clinical trial.