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An Open-label, Dose Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505627-30-00
Acronym
TAK-676-1002
Enrollment
114
Registered
2024-06-03
Start date
2023-07-26
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Neoplasm

Brief summary

Frequency and severity of TEAEs., Number of patients with DLTs., Number and percentage of patients with 1 or more treatment-emergent SAE., Number and percentage of patients with 1 or more TEAE leading to dose modifications and treatment discontinuation., Safety endpoints will be evaluated according to the (NCI CTCAE), Version 5.0.

Detailed description

Dose escalation, Japan safety lead-in, and expansion phases:, Response assessments per (RECIST) v.1.1 (Eisenhauer et al. 2009) by investigator – ORR ([cCR] + [cPR])., Response assessments per (RECIST) v.1.1 (Eisenhauer et al. 2009) by investigator. DCR (cCR + cPR + [SD] >6 weeks)., Response assessments per (RECIST) v.1.1 (Eisenhauer et al. 2009) by investigator. DOR., Response assessments per (RECIST) v.1.1 (Eisenhauer et al. 2009) by investigator. TTR., Expansion phase only: Response assessments per RECIST v.1.1 by investigator – PFS, Response assessments per RECIST v.1.1 by investigator. OS, Response assessments per RECIST v.1.1 by investigator. OS rate at 12 months, Response assessments per RECIST v.1.1 by investigator. OS rate at 6 months

Interventions

DRUGCISPLATIN
DRUGCARBOPLATIN
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGFLUOROURACIL

Sponsors

Takeda Development Center Americas Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Frequency and severity of TEAEs., Number of patients with DLTs., Number and percentage of patients with 1 or more treatment-emergent SAE., Number and percentage of patients with 1 or more TEAE leading to dose modifications and treatment discontinuation., Safety endpoints will be evaluated according to the (NCI CTCAE), Version 5.0.—

Secondary

MeasureTime frame
Dose escalation, Japan safety lead-in, and expansion phases:, Response assessments per (RECIST) v.1.1 (Eisenhauer et al. 2009) by investigator – ORR ([cCR] + [cPR])., Response assessments per (RECIST) v.1.1 (Eisenhauer et al. 2009) by investigator. DCR (cCR + cPR + [SD] >6 weeks)., Response assessments per (RECIST) v.1.1 (Eisenhauer et al. 2009) by investigator. DOR., Response assessments per (RECIST) v.1.1 (Eisenhauer et al. 2009) by investigator. TTR., Expansion phase only: Response assessments per RECIST v.1.1 by investigator – PFS, Response assessments per RECIST v.1.1 by investigator. OS, Response assessments per RECIST v.1.1 by investigator. OS rate at 12 months, Response assessments per RECIST v.1.1 by investigator. OS rate at 6 months—

Countries

Austria, Belgium, France, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026