18 and older, any sex, with Advanced or Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)Primary· Up to approximately 24 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. AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 except cytokine release syndrome (CRS), which was grad
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
3
Dose Escalation: TAK-981 60 mg
6
Dose Escalation: TAK-981 90 mg
33
Dose Escalation: TAK-981 120 mg
19
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)Primary· Up to Cycle 1 (each cycle was of 21 days)
DLTs were evaluated according to NCI CTCAE Version 5.0 except CRS, which was graded according to ASTCT Consensus Grading for CRS.
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
0
Dose Escalation: TAK-981 60 mg
0
Dose Escalation: TAK-981 90 mg
2
Dose Escalation: TAK-981 120 mg
1
Phase 1: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)Primary· Up to approximately 24 months
AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. A severity grade was evaluated as per the NCI CTCAE Version 5.0, except for CRS, which was assessed by ASTCT Consensus Grading for CRS.
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
0
Dose Escalation: TAK-981 60 mg
2
Dose Escalation: TAK-981 90 mg
20
Dose Escalation: TAK-981 120 mg
15
Phase 1: Number of Participants With One or More Serious Adverse Events (SAEs)Primary· Up to approximately 24 months
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 that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
0
Dose Escalation: TAK-981 60 mg
3
Dose Escalation: TAK-981 90 mg
17
Dose Escalation: TAK-981 120 mg
10
Phase 1: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment DiscontinuationPrimary· Up to approximately 24 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.
TEAE Resulting in Dose Modifications of TAK-981
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
0
Dose Escalation: TAK-981 60 mg
3
Dose Escalation: TAK-981 90 mg
22
Dose Escalation: TAK-981 120 mg
11
TEAE Resulting in Dose Modifications of Pembrolizumab
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
0
Dose Escalation: TAK-981 60 mg
3
Dose Escalation: TAK-981 90 mg
15
Dose Escalation: TAK-981 120 mg
4
TEAE Resulting in Drug Discontinuation of TAK-981
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
0
Dose Escalation: TAK-981 60 mg
1
Dose Escalation: TAK-981 90 mg
3
Dose Escalation: TAK-981 120 mg
2
TEAE Resulting in Drug Discontinuation of Pembrolizumab
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
0
Dose Escalation: TAK-981 60 mg
1
Dose Escalation: TAK-981 90 mg
4
Dose Escalation: TAK-981 120 mg
1
Phase 1: Number of Participants With Clinically Significant Laboratory ValuesPrimary· Up to approximately 24 months
Laboratory parameters included clinical chemistry, hematology, and urinalysis. Participants with at least 1 Grade 3 or 4 Lab Abnormalities were reported.
Hematology
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
1
Dose Escalation: TAK-981 60 mg
3
Dose Escalation: TAK-981 90 mg
7
Dose Escalation: TAK-981 120 mg
6
Serum Chemistry
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
1
Dose Escalation: TAK-981 60 mg
1
Dose Escalation: TAK-981 90 mg
7
Dose Escalation: TAK-981 120 mg
5
Coagulation
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
0
Dose Escalation: TAK-981 60 mg
0
Dose Escalation: TAK-981 90 mg
0
Dose Escalation: TAK-981 120 mg
1
Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator According to RECIST, Version 1.1Primary· Up to approximately 25 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 Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Phase 1: Cmax: Maximum Observed Plasma Concentration for TAK-981Secondary· Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
335
± 282
Dose Escalation: TAK-981 60 mg
728
± 396
Dose Escalation: TAK-981 90 mg
888
± 423
Dose Escalation: TAK-981 120 mg
1290
± 571
Cycle 1 Day 8
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
280
± 167
Dose Escalation: TAK-981 60 mg
448
± 206
Dose Escalation: TAK-981 90 mg
780
± 524
Dose Escalation: TAK-981 120 mg
1270
± 770
Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981Secondary· Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
1.22
1.20 – 1.23
Dose Escalation: TAK-981 60 mg
1.27
1.00 – 1.47
Dose Escalation: TAK-981 90 mg
1.17
1.00 – 1.88
Dose Escalation: TAK-981 120 mg
1.20
1.00 – 1.72
Cycle 1 Day 8
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
1.18
1.17 – 1.25
Dose Escalation: TAK-981 60 mg
1.41
1.00 – 1.70
Dose Escalation: TAK-981 90 mg
1.22
1.00 – 3.10
Dose Escalation: TAK-981 120 mg
1.28
0.98 – 1.50
Phase 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981Secondary· Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
880
± 427
Dose Escalation: TAK-981 60 mg
1370
± 517
Dose Escalation: TAK-981 90 mg
1950
± 735
Dose Escalation: TAK-981 120 mg
2580
± 949
Cycle 1 Day 8
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
814
± 290
Dose Escalation: TAK-981 60 mg
976
± 232
Dose Escalation: TAK-981 90 mg
1780
± 908
Dose Escalation: TAK-981 120 mg
2640
± 1260
Phase 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981Secondary· Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
909
± 432
Dose Escalation: TAK-981 60 mg
1400
± 530
Dose Escalation: TAK-981 90 mg
2020
± 760
Dose Escalation: TAK-981 120 mg
2660
± 1020
Cycle 1 Day 8
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
845
± 292
Dose Escalation: TAK-981 60 mg
1010
± 233
Dose Escalation: TAK-981 90 mg
1830
± 942
Dose Escalation: TAK-981 120 mg
2750
± 1320
Phase 1: t1/2z: Terminal Disposition Phase Half-life for TAK-981Secondary· Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
5.88
5.82 – 6.16
Dose Escalation: TAK-981 60 mg
5.58
5.04 – 6.03
Dose Escalation: TAK-981 90 mg
5.72
3.31 – 10.43
Dose Escalation: TAK-981 120 mg
6.79
5.93 – 8.14
Cycle 1 Day 8
Group
Value
95% CI
Dose Escalation: TAK-981 40 mg
5.83
5.69 – 6.33
Dose Escalation: TAK-981 60 mg
5.68
5.22 – 6.44
Dose Escalation: TAK-981 90 mg
6.06
4.18 – 9.13
Dose Escalation: TAK-981 120 mg
6.67
5.26 – 8.08
Adverse events — posted to ClinicalTrials.gov
Time frame: Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors.
The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab.
Participants will be on this combination treatment for 21-day cycles. They will continue with this treatment for up to 24 months or until participants meet any discontinuation criteria.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04776018 — A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)
· Phase 1, PHASE2
· terminated
NCT04065555 — Intratumoral Microdosing of TAK-981 in Head and Neck Cancer
· EARLY_PHASE1
· completed
NCT04074330 — A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma
· Phase 1, PHASE2
· terminated
NCT03648372 — A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
· Phase 1, PHASE2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 10 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04381650.