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TAK-981 for Cancer and Lymphoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult male or female participants ≥18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of TAK-981 in people with advanced solid tumors or lymphomas.

Who is the study for?
This trial is for adults with advanced solid tumors or immune system cancers who've had limited previous treatments and no recent anticancer therapies. They must be in good physical condition, not have certain heart conditions or psychiatric illnesses, and can't be pregnant or breastfeeding. Participants should not have a history of severe reactions to immunotherapy.Check my eligibility
What is being tested?
TAK-981 is being tested on people with specific types of cancer. The first part determines the highest dose without serious side effects; the second part assesses if TAK-981 improves patients' conditions at that dose. Treatment involves receiving TAK-981 intravenously for up to a year.See study design
What are the potential side effects?
Possible side effects from TAK-981 include reactions at the infusion site, general discomfort, potential organ inflammation, and an increased risk of infections due to immune system effects. Specific side effect details will emerge as the trial progresses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can carry out all my daily activities without help.
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I have advanced cancer or lymphoma with no standard treatment options left.
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My advanced cancer is incurable and standard treatments have failed.
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My nonsquamous NSCLC progressed after 1-2 treatments but didn't worsen in the first 5 months of the first CPI therapy.
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My cancer progressed despite targeted therapy for specific genetic changes.
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I have cervical cancer and have had only one treatment for it since it became advanced.
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My cervical cancer is not one of the excluded types and has been confirmed by a pathology report.
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My first cancer treatment included platinum-based drugs but not with primary radiation.
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I have colorectal cancer, haven't had CPI treatment, and tried up to 3 chemo types.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Number of Participants Based on Severity of TEAEs
Phase 1: Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)
Phase 1: Number of Participants With Clinically Significant Laboratory Values
+2 more
Secondary outcome measures
Phase 1 and Phase 2: Disease Control Rate (DCR)
Phase 1 and Phase 2: Duration of Response (DOR)
Phase 1 and Phase 2: Progression-free Survival (PFS)
+14 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Phase 2, Cohort F: r/r Follicular LymphomaExperimental Treatment1 Intervention
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with relapsed/refractory follicular lymphoma (FL).
Group II: Phase 2, Cohort E: r/r DLBCL without prior cellular therapyExperimental Treatment1 Intervention
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with relapsed/refractory DLBCL that have not received prior cellular therapy.
Group III: Phase 2, Cohort D: r/r DLBCL after CAR T-cells therapyExperimental Treatment1 Intervention
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after prior chimeric antigen receptor (CAR) T-cells therapy.
Group IV: Phase 2, Cohort C: MSS-CRCExperimental Treatment1 Intervention
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with microsatellite-stable colorectal cancer (MSS-CRC).
Group V: Phase 2, Cohort B: Cervical CancerExperimental Treatment1 Intervention
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with cervical cancer.
Group VI: Phase 2, Cohort A: Nonsquamous NSCLCExperimental Treatment1 Intervention
TAK-981 intravenously administered as 60 minute-infusion in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study in participants with nonsquamous non-small cell lung cancer (NSCLC).
Group VII: Phase 1, Dose Escalation Cohort: TAK-981Experimental Treatment1 Intervention
TAK-981, intravenously, administered as 60 minute-infusion, once on Days 1, 4, 8, and 11 in a 21-day treatment cycle for up to approximately 12 months or until discontinuation from the study. If clinical safety, pharmacokinetics, and pharmacodynamics are supportive, the dosing schedule may be modified to evaluate a less intensive administration of TAK-981 on Day 1, or Days 1 and 8, or Day 1, Day 8, and Day 15 in 21-day cycles in participants with advanced or metastatic solid tumors or lymphomas. Dose levels will be escalated based on the Bayesian logistic regression modeling (BLRM). The dose escalation phase will determine the RP2D of TAK-981.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-981
2020
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,198 Previous Clinical Trials
4,178,112 Total Patients Enrolled
45 Trials studying Lymphoma
13,782 Patients Enrolled for Lymphoma
Study DirectorStudy DirectorTakeda
1,202 Previous Clinical Trials
489,541 Total Patients Enrolled
42 Trials studying Lymphoma
11,129 Patients Enrolled for Lymphoma
Medical DirectorStudy DirectorTakeda
2,769 Previous Clinical Trials
8,061,959 Total Patients Enrolled
40 Trials studying Lymphoma
11,691 Patients Enrolled for Lymphoma

Media Library

TAK-981 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03648372 — Phase 1 & 2
Lymphoma Research Study Groups: Phase 2, Cohort A: Nonsquamous NSCLC, Phase 2, Cohort C: MSS-CRC, Phase 2, Cohort D: r/r DLBCL after CAR T-cells therapy, Phase 2, Cohort E: r/r DLBCL without prior cellular therapy, Phase 2, Cohort F: r/r Follicular Lymphoma, Phase 1, Dose Escalation Cohort: TAK-981, Phase 2, Cohort B: Cervical Cancer
Lymphoma Clinical Trial 2023: TAK-981 Highlights & Side Effects. Trial Name: NCT03648372 — Phase 1 & 2
TAK-981 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03648372 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an innovative clinical trial?

"There are 4 ongoing clinical trials for TAK-981 across 67 cities and 10 countries. The first study was held in 2018 and completed both Phase 1 & 2 of drug approval. Since then, 1 trial has been conducted every year."

Answered by AI

Are there any current openings for participants in this trial?

"This clinical trial, as indicated by the website clinicaltrials.gov is recruiting patients at this time. The first posting for this trial was on October 1st 2018 with the most recent update taking place on April 18th 2022."

Answered by AI

How many people are allowed to participate in this clinical trial at one time?

"In order to carry out this research, 202 patients who meet the necessary requirements must be recruited. Takeda, the sponsor of the trial, will manage it from various locations - two being Fox Chase Cancer Center in Philadelphia and Froedtert and the Medical College of Wisconsin in Milwaukee."

Answered by AI

What other medical experiments have included TAK-981?

"Currently, there are 4 different ongoing research studies on TAK-981. 0 of these trials have reached Phase 3 clinical stages. The majority of the 106 locations running these tests are based in Pittsburgh, Pennsylvania; however, other states are represented as well."

Answered by AI

Is this study happening at a lot of different hospitals in the US?

"This study is currently recruiting at 7 locations, which include Fox Chase Cancer Center in Philadelphia, Froedtert and the Medical College of Wisconsin in Milwaukee, Massachusetts General Hospital in Boston, as well as 4 other sites."

Answered by AI
~17 spots leftby Mar 2025