TAK-676 for Solid Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid Neoplasms
TAK-676 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying TAK-676 given alone or together with pembrolizumab to see how well it works in treating patients with solid tumors that have spread to other parts of the body.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Neoplasms

Study Objectives

4 Primary · 36 Secondary · Reporting Duration: Up to approximately 54 months

Day 21
Kidney
CLR: Renal Clearance for TAK-676
Percentage of Dose Excreted in Urine During 24 Hours After Dosing
Day 21
AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-676
AUCt: Area under the Concentration-time Curve From Time 0 to Time t for TAK-676
CL: Total Clearance After Intravenous Administration for TAK-676
Cmax: Maximum Observed Plasma Concentration for TAK-676
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-676
Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-676
t1/2: Terminal Disposition Phase Half-life for TAK-676
Month 54
Dose Escalation and Expansion Phases: AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-676
Dose Escalation and Expansion Phases: AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for TAK-676
Dose Escalation and Expansion Phases: CL: Total Clearance After Intravenous Administration for TAK-676
Dose Escalation and Expansion Phases: CLR/CL%: Renal Clearance as Percentage of Total Clearance for TAK-676
Dose Escalation and Expansion Phases: CLR: Renal Clearance for TAK-676
Dose Escalation and Expansion Phases: Cmax: Maximum Observed Plasma Concentration for TAK-676
Dose Escalation and Expansion Phases: Percentage of Dose Excreted in Urine During 24 Hours After Dosing
Dose Escalation and Expansion Phases: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-676
Dose Escalation and Expansion Phases: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-676
Dose Escalation and Expansion Phases: t1/2z: Terminal Disposition Phase Half-life for TAK-676
Up to 24 months
Expansion Phase Only: OS Rate at 12 Months
Expansion Phase Only: OS Rate at 6 Months
Up to 30 months
Disease Control Rate (DCR)
Duration of Response (DOR)
Number of Participants with Upregulation of TAK-676-Induced Stimulator of Interferon Genes (STING)
Overall Response Rate (ORR)
Time to Response (TTR)
Month 24
Expansion Phase Only: Overall Survival (OS)
Expansion Phase Only: Progression-Free Survival (PFS)
Month 54
Dose Escalation and Expansion Phases: Disease Control Rate (DCR)
Dose Escalation and Expansion Phases: Duration of Response (DOR)
Dose Escalation and Expansion Phases: Number of Participants With T-cell Infiltration Upon TAK-676 Treatment
Dose Escalation and Expansion Phases: Number of Participants with Upregulation of TAK-676-Induced Stimulator of Interferon Genes (STING)
Dose Escalation and Expansion Phases: Overall Response Rate (ORR)
Genome
Dose Escalation and Expansion Phases: Time to Response (TTR)
Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity
Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
Number of Participants with Dose-Limiting Toxicities (DLTs)

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Neoplasms

Trial Design

8 Treatment Groups

Monotherapy Dose Escalation Phase: TAK-676 SA
1 of 8
Combination Dose Escalation Phase: TAK-676 + Pembrolizumab
1 of 8
Part 1 (Monotherapy Dose Escalation Phase): TAK-676 Safety Lead-in + TAK-676 SA ...
1 of 8
Part 1B (Combination Dose Escalation Phase): TAK-676 + Pembrolizumab
1 of 8
Part 3B (Expansion Phase in CRC): TAK-676 + Pembrolizumab in MSS/pMMR CRC
1 of 8
Experimental: Part 3A (Expansion Phase in CRC): TAK-676 + Pembrolizumab in MSI-H...
1 of 8
Part 2A (SCCHN Dose Expansion Phase): TAK-676 + Pembrolizumab
1 of 8
Part 2B (SCCHN Dose Expansion Phase): TAK-676 + Pembrolizumab + Chemotherapy
1 of 8
Experimental Treatment

288 Total Participants · 8 Treatment Groups

Primary Treatment: TAK-676 · No Placebo Group · Phase 1

Monotherapy Dose Escalation Phase: TAK-676 SA
Drug
Experimental Group · 1 Intervention: TAK-676 · Intervention Types: Drug
Combination Dose Escalation Phase: TAK-676 + PembrolizumabExperimental Group · 2 Interventions: TAK-676, Pembrolizumab · Intervention Types: Drug, Drug
Part 1 (Monotherapy Dose Escalation Phase): TAK-676 Safety Lead-in + TAK-676 SA [Part 1A]
Drug
Experimental Group · 1 Intervention: TAK-676 · Intervention Types: Drug
Part 1B (Combination Dose Escalation Phase): TAK-676 + PembrolizumabExperimental Group · 2 Interventions: TAK-676, Pembrolizumab · Intervention Types: Drug, Drug
Part 3B (Expansion Phase in CRC): TAK-676 + Pembrolizumab in MSS/pMMR CRCExperimental Group · 2 Interventions: TAK-676, Pembrolizumab · Intervention Types: Drug, Drug
Experimental: Part 3A (Expansion Phase in CRC): TAK-676 + Pembrolizumab in MSI-H/dMMR CRCExperimental Group · 2 Interventions: TAK-676, Pembrolizumab · Intervention Types: Drug, Drug
Part 2A (SCCHN Dose Expansion Phase): TAK-676 + PembrolizumabExperimental Group · 2 Interventions: TAK-676, Pembrolizumab · Intervention Types: Drug, Drug
Part 2B (SCCHN Dose Expansion Phase): TAK-676 + Pembrolizumab + ChemotherapyExperimental Group · 4 Interventions: TAK-676, Platinum, 5-fluorouracil, Pembrolizumab · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platinum
2008
Completed Phase 3
~30
5-fluorouracil
2005
Completed Phase 4
~7820
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 54 months

Who is running the clinical trial?

TakedaLead Sponsor
1,108 Previous Clinical Trials
4,042,567 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,055 Previous Clinical Trials
473,253 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a performance status of 0 to 1.
You have advanced or metastatic solid tumors that have no standard therapeutic options or are intolerant to these therapies.
The anatomical subsites to be included are oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, and paranasal sinuses (maxillary, ethmoid, sphenoid, and frontal).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.