Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-188 · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. Severity for each TEAE will be determined using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
DLTs will be evaluated according to NCI CTCAE, Version 5.0 except cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), will be graded according to American society for transplantation and cellular therapy (ASCST) Consensus Grading for CRS.
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event.
ORR is defined as the percentage of participants who achieve Complete Response (CR) and Partial Response (PR) (determined by the investigator) during the study according to RECIST Version 1.1. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease by 30% and no new sites of disease. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
DCR is defined as the percentage of participants who achieve SD or better (CR+PR+SD determined by the investigator) equal to or more than (≥) 6 weeks during the study.
DOR is defined as the time from the date of first documentation of a confirmed partial response (cPR) or better to the date of first documentation of PD or death for responders (cPR or better).
| Arm | Type | Description |
|---|---|---|
| Phase 1: TAK-188 Dose Escalation | EXPERIMENTAL | Participants will receive escalating doses of TAK-188 with a starting dose of 40 micrograms per kilogram (μg/kg), intravenously (IV) infusion, on Days 1, 8, and 15 \[once weekly (QW)\] or Day 1 only \[once every three weeks (Q3W)\] in each 21-day treatment cycles, respectively, or Days 1 and 15 \[once every 2 weeks (Q2W)\] or Day 1 only \[once every 4 weeks (Q4W)\] in 28-day treatment cycles until recommended dose for expansion (RDE) is determined (for a maximum of 12 months). |
| Phase 1b: Backfill Cohort | EXPERIMENTAL | Participants with squamous cell carcinoma of head and neck (SCCHN) or pancreatic ductal adenocarcinoma (PDAC) will receive TAK-188 at RDE1 (recommended dose for expansion in Phase 1), IV infusion on Days 1, 8, and 15 (QW) in each 21-day treatment cycle (for a maximum of 12 months). |
| Phase 2; Dose Expansion: Cohort A | EXPERIMENTAL | Participants with non-squamous non-small cell lung cancer (NSCLC) or PDAC will receive TAK-188 at RDE1, IV infusion on Days 1, 8, and 15 (QW) in each 21-day treatment cycle (for a maximum of 12 months). |
| Phase 2; Dose Optimization | EXPERIMENTAL | Participants with NSCLC/PDAC/SCCHN will receive TAK-188 at RDE1 or RDE2 or RDE3, (where RDE2 and RDE3 represents additional recommended doses or dose schedules) for a maximum of 12 months. |
| Phase 2; Dose Expansion: Cohort B (Optional) | EXPERIMENTAL | Participants with gastroesophageal adenocarcinoma (GEA) will receive TAK-188 at RDE1, or RDE2 or RDE3, (where RDE2 and RDE3 represents additional recommended doses or dose schedules) for a maximum of 12 months. |
| Name | Type | Description |
|---|---|---|
| TAK-188 | DRUG | TAK-188 IV infusion. |
Inclusion Criteria: 1. Participants greater than or equal to (≥)18 years or ≥ the local legal age of majority, as applicable, at the time of signing the informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 3. Participants must provide biopsy samples (cor...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TAK-188 is an investigational small molecule oncology drug being developed by Takeda Pharmaceutical Company Limited. It is being studied in adults with advanced or metastatic solid tumors. TAK-188 is in Phase 1 clinical development and has not been approved for any indication.
TAK-188 is being evaluated for the treatment of advanced or metastatic solid tumors in adults. It is an investigational therapy and is not approved for commercial use. The Phase 1 study enrolls patients with advanced or spreading solid tumors.
TAK-188 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the Phase 1 clinical trial evaluating TAK-188 in patients with advanced or metastatic solid tumors.
TAK-188 is in Phase 1 clinical development. It is an investigational small molecule and has not received FDA approval. The single Phase 1 trial is currently recruiting participants with advanced or metastatic solid tumors.
TAK-188 is being studied in one Phase 1 clinical trial, NCT07205718, titled A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors. The trial is recruiting up to 273 participants aged 18 and older in the United States.