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TAK-188

Phase 1

Advanced or Metastatic Solid Tumors | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment223
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07205718A Study of TAK-188 in Adults With Advanced or Spreading Solid TumorsPHASE1 RECRUITING 223Nov 19, 2025Dec 21, 2029Jun 5, 202615 United States
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Study Endpoints
Primary Endpoints
Phase 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
From the signing of the informed consent form (ICF) through 90 days after the last dose (Up to approximately 16 months)

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.

Phase 1: Number of Participants with TEAEs Based on Severity
From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)

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.

Phase 1: Number of Participants with Dose- limiting Toxicities (DLTs)
Up to Cycle 1 (21 days)

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.

Phase 1: Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)

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.

Phase 1: Number of Participants with Treatment-emergent Adverse Events Leading to Dose Modifications and Treatment Discontinuations
From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)
Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Up to 24 months

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).

Phase 2: Disease Control Rate (DCR)
Up to 24 months

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.

Phase 2: Duration of Response (DOR)
Up to 24 months

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).

Secondary Endpoints
Phase 1: Recommended Dose for Expansion [RDE(s)] of TAK-188
Up to 12 months
Phase 1: Cmax: Maximum Observed Plasma Concentration
Cycles 1 & 3: Day 1 (pre-dose, end of infusion, 5, 24, 48 & 72 hours post infusion); Days 8 & 15 (pre-dose); Cycles 2 & 4: Day 1 (pre-dose, end of infusion); Cycles 5,7 & 9: Day 1 (pre-dose) & at end of treatment (Cycle length:21 days)
Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax)
Cycles 1 & 3: Day 1 (pre-dose, end of infusion, 5, 24, 48 & 72 hours post infusion); Days 8 & 15 (pre-dose); Cycles 2 & 4: Day 1 (pre-dose, end of infusion); Cycles 5,7 & 9: Day 1 (pre-dose) & at end of treatment (Cycle length:21 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1: TAK-188 Dose EscalationEXPERIMENTALParticipants 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 \[once weekly (QW)\] in each 21-day treatment cycles until recommended dose for expansion (RDE) is determined (for a maximum of 12 months).
Phase 1b: Backfill CohortEXPERIMENTALParticipants with squamous cell carcinoma of head and neck (SCCHN) 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 AEXPERIMENTALParticipants with non-squamous non-small cell lung cancer (NSCLC) 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 Expansion: Cohort BEXPERIMENTALParticipants with NSCLC will receive TAK-188 at RDE2 (a lower dose than RDE1 or an alternate dose schedule), IV infusion, on Days 1, 8, and 15 (QW) in each 21-day treatment cycle or once every 2 weeks (Q2W) in each 28-day treatment cycle (for a maximum of 12 months).
Phase 2; Dose Expansion: Cohort CEXPERIMENTALParticipants with NSCLC will receive TAK-188 at RDE3 (recommended dose for expansion at an alternate dose schedule), IV infusion, Q2W in each 28-day treatment cycle (for a maximum of 12 months).
Phase 2; Dose Expansion: Cohort DEXPERIMENTALParticipants with gastroesophageal adenocarcinoma (GEA) will receive TAK-188, IV infusion on Days 1, 8, and 15 (QW) in each 21-day treatment cycle (for a maximum of 12 months).
Interventions
NameTypeDescription
TAK-188DRUGTAK-188 IV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Participants ≥18 years or ≥ the local legal age of majority, as applicable, at the time of signing the ICF. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 3. Participants must provide biopsy samples (core needle or other surgical procedure) collect...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07205718lastUpdatePostDate: changed
LOWJun 5, 2026NCT07205718lastUpdatePostDate: changed
LOWJun 5, 2026NCT07205718lastUpdatePostDate: changed
LOWJun 5, 2026NCT07205718lastUpdatePostDate: changed
LOWMay 26, 2026NCT07205718primaryCompletionDate: changed
LOWMay 24, 2026NCT07205718studyFirstPostDate: changed