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Monoclonal Antibodies
TAK-676 + Pembrolizumab for Metastatic Cancer (iintune-1 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CRC (Part 3): Third-line or later MSI-H/dMMR CRC (Part 3A): histologically confirmed recurrent locally advanced or metastatic MSI-H/dMMR CRC with disease progression on or following therapy with anti-PD-1 or PD-L1 antibody and at least one line of combination chemotherapy, Third-line MSS/pMMR CRC (Part 3B): histologically confirmed recurrent locally advanced or metastatic MSS/pMMR CRC with disease progression on or following therapy with 2 different lines of combination chemotherapy, MSI/MMR status confirmed by a clinically-approved IHC and/or PCR assay, treated with 2 prior lines of therapy in the recurrent locally advanced or metastatic setting
TAK-676 SA (dose escalation Part 1A): histologically confirmed advanced or metastatic solid tumors with no standard therapeutic options or intolerant to these therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to month 54
Awards & highlights
iintune-1 Trial 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.
Who is the study for?
Adults with advanced or metastatic solid tumors who haven't responded to standard treatments, or can't tolerate them, may join this trial. They should be in good physical condition (ECOG 0-1), have not received certain vaccines recently, and must not have active hepatitis or heart issues. Smokers and those with specific lung conditions cannot participate.Check my eligibility
What is being tested?
The study is testing TAK-676 alone and combined with Pembrolizumab to find the highest dose patients can take without severe side effects. It includes a phase where doses increase (dose escalation) followed by a phase that tests the chosen dose more broadly (dose expansion). Some will also receive chemotherapy drugs like Platinum and 5-fluorouracil.See study design
What are the potential side effects?
Possible side effects of TAK-676 include reactions at the infusion site, fatigue, digestive problems, blood disorders, increased risk of infections, and potential organ inflammation. Pembrolizumab might cause immune-related adverse effects such as skin rash or thyroid dysfunction.
iintune-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have advanced cancer with no standard treatment options left or cannot tolerate them.
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I can carry out all my daily activities without help.
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My cancer is advanced or has spread, and standard treatments haven't worked or can't be used.
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My cancer did not respond to previous immunotherapy treatments.
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My advanced cancer has no standard treatment options left, or I can't tolerate them.
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I am fully active or can carry out light work.
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My tumor has not been treated with anti-PD-1 or anti-PD-L1 therapy.
iintune-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to month 54
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to month 54
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
+1 moreSecondary outcome measures
Dose Escalation Phase: Percentage of Dose Excreted in Feces During 24 Hours After Dosing
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity for Dazostinag
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Dazostinag
+19 moreiintune-1 Trial Design
7Treatment groups
Experimental Treatment
Group I: Part 3B (Expansion and Dose Optimization Phase in CRC): Dazostinag + Pembrolizumab in MSS/pMMR CRCExperimental Treatment2 Interventions
Dazostinag 5.0 mg, infusion, IV, will be administered in participants with microsatellite stable/mismatch repair proficient (MSS/pMMR) CRC at the identified dose level from Part 1 on Days 1, 8, and 15 in a 21-day cycle. along with pembrolizumab 200 mg infusion, IV, Q3W.
Dose optimization may be performed in this phase.
Group II: Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + ChemotherapyExperimental Treatment4 Interventions
Dazostinag 5.0 mg, infusion, IV, will be administered in participants with SCCHN at the identified dose level from Part 1 on Days 1, 8, and 15 in a 21-day cycle. Pembrolizumab infusion, IV will be administered at 200 mg Q3W. Platinum-based chemotherapy comprising the combination of carboplatin (target area under the curve of 5 mg/mL/minute[AUC 5]) or cisplatin (100 milligrams per square meter [mg/m^2] Day 1 of each treatment cycle), and 5-fluorouracil ([5-FU]; 1000 mg/m^2 per day for 4 consecutive days) every 3 weeks for up to 6 cycles.
Group III: Part 2A (SCCHN CPS ≥ 1 Dose Expansion and Optimization Phase): Dazostinag + PembrolizumabExperimental Treatment2 Interventions
Dazostinag 5.0 mg, infusion, IV, will be administered in participants with squamous cell carcinoma of head and neck (SCCHN) at the identified dose level from Part 1 on Days 1, 8, and 15 in a 21-day cycle along with pembrolizumab 200 mg infusion, IV, Q3W. Dose optimization may be performed in this phase.
Group IV: Part 1B (Combination Dose Escalation Phase): Dazostinag + PembrolizumabExperimental Treatment2 Interventions
Dazostinag escalating doses (0.2 mg and above) in combination with pembrolizumab 200 mg, infusion, IV, once weekly on Days 1, 8 and 15 in each 21-day treatment cycle. Pembrolizumab 200 mg will be administered 1 hour prior to Dazostinag once every 3 weeks (Q3W). The dosing will be initiated when at least two dose levels (DLs) of Part 1A have been evaluated.
Group V: Part 1 (Monotherapy Dose Escalation Phase): Dazostinag Safety Lead-in + Dazostinag SA [Part 1A]Experimental Treatment1 Intervention
Safety Lead-in: Dazostinag 0.1 mg, infusion, intravenously (IV), once weekly, on Days 1, 8 and 15 in 21-day treatment cycles.
Dazostinag single agent (SA) Dose Escalation (Part 1A): Dazostinag SA, infusion, IV, once weekly on Days 1, 8 and 15 in each 21-day treatment cycles with escalating doses (0.2 mg and above). The dosing will be initiated in the Dazostinag SA Dose Escalation Phase based on the available safety and tolerability data from the Safety Lead-in.
Group VI: Japan Safety Lead-in Dazostinag ± PembrolizumabExperimental Treatment2 Interventions
Dazostinag 5.0 mg, infusion, IV, once on Day 1 in Cycle 0 (cycle length=7 days) in Japanese participants with advanced or metastatic solid tumors. Following the 7-day Cycle 0, participants who do not develop any DLT in Cycle 0 will be administered Dazostinag on Days 1, 8, and 15 of a 21-day cycle in combination with pembrolizumab administered Q3W, IV, in Cycle 1. If no DLTs are observed, study treatment will start with Dazostinag in combination with pembrolizumab administered on Day 1 of each 21-day treatment cycle.
Additional dose levels of Dazostinag (such as 3.5 mg or 7.0 mg and higher) in combination with pembrolizumab (200 mg, Q3W) may be explored in the Safety Lead in.
Group VII: Experimental: Part 3A (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSI-H/dMMR CRCExperimental Treatment2 Interventions
Dazostinag 5.0 mg, infusion, IV, will be administered in participants with microsatellite instability-high /mismatch repair deficient (MSI-H/dMMR) colorectal cancer (CRC) at the identified dose level from Part 1 on Days 1, 8, and 15 in a 21-day cycle along with pembrolizumab 200 mg infusion, IV, Q3W.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Platinum
Not yet FDA approved
Fluorouracil
FDA approved
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,648 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,209 Previous Clinical Trials
489,096 Total Patients Enrolled
3 Trials studying Tumors
222 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently smoking.I have advanced cancer with no standard treatment options left or cannot tolerate them.My side effects from previous treatments have mostly gone, except for possible hair loss, mild nerve pain, or hormone issues treated with stable medication.My throat cancer cannot be removed by surgery and I haven't had systemic therapy for it in its advanced stage.My cancer is in my mouth, throat, voice box, nose, or sinuses but not in my nasopharynx or salivary glands.I haven't taken STING or toll-like receptor treatments in the last 6 months.I can carry out all my daily activities without help.I agree to two tumor biopsies and have at least one measurable cancer lesion.I cannot take pembrolizumab due to adverse reactions or medical reasons.My SCCHN cancer cannot be removed by surgery, has not been treated before in its current advanced stage, and I might be eligible for specific chemotherapy.I agree to provide tissue for HPV testing or already have HPV test results if I have cancer in the throat or sinuses.My colorectal cancer is MSI-H/dMMR and has not improved after specific treatments.My brain metastasis has been stable for over 6 weeks, and I'm not on corticosteroids.I have not received a live vaccine in the last 28 days.My heart's pumping ability is good, confirmed by a recent heart scan.My heart, liver, kidneys, and bone marrow are functioning well.I haven't taken steroids or immunosuppressants within the last week.My cancer is advanced or has spread, and standard treatments haven't worked or can't be used.My cancer did not respond to previous immunotherapy treatments.My advanced cancer has no standard treatment options left, or I can't tolerate them.I do not have severe lung problems or uncontrolled fluid in my lungs or abdomen.For Part 2A, your tumor must have a CPS of 1 or higher. For Part 2B, your tumor can have any CPS score.I am fully active or can carry out light work.I have experienced moderate to severe low blood pressure.I cannot tolerate or am allergic to platinum-based chemotherapy and 5-FU.I am eligible for treatment with cisplatin or carboplatin and 5-FU.My tumor has not been treated with anti-PD-1 or anti-PD-L1 therapy.I have ongoing, active hepatitis.My blood samples for drug testing can be taken through a catheter, and I can receive TAK-676 either through a central line or by peripheral infusion.You have used e-cigarettes within the past 90 days before starting the study drug.I currently have a serious infection or a high fever due to cancer.I have refused all standard treatments available.I haven't had radiation therapy in the last 14 days or lung radiation in the last 42 days.I am not taking drugs that affect liver transport proteins.I have received a stem cell or organ transplant.I am not on any cancer treatment except hormone therapy for breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 (Monotherapy Dose Escalation Phase): Dazostinag Safety Lead-in + Dazostinag SA [Part 1A]
- Group 2: Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy
- Group 3: Part 2A (SCCHN CPS ≥ 1 Dose Expansion and Optimization Phase): Dazostinag + Pembrolizumab
- Group 4: Experimental: Part 3A (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSI-H/dMMR CRC
- Group 5: Part 3B (Expansion and Dose Optimization Phase in CRC): Dazostinag + Pembrolizumab in MSS/pMMR CRC
- Group 6: Part 1B (Combination Dose Escalation Phase): Dazostinag + Pembrolizumab
- Group 7: Japan Safety Lead-in Dazostinag ± Pembrolizumab
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for potential participants in this experiment?
"According to the clinicaltrials.gov webpage, this trial is currently open for enrolment and has been since July 22nd 2020 - with its last edit taking place on October 13th 2022."
Answered by AI
What potential risks could patients face when taking TAK-676?
"The safety profile of TAK-676 has only been assessed in a few clinical trials, so its risk level is estimated to be 1."
Answered by AI
Have any previous experiments been conducted with TAK-676?
"Presently, 961 clinical trials are being conducted with TAK-676. Of those studies, 122 have advanced to the Phase 3 stage of development. Houston, Texas is at the centre of these operations; however, there are an additional 35 731 locations that house active trials for this medication."
Answered by AI
How many participants are eligible to join in this research endeavor?
"To fulfill the requirements of this medical trial, 288 individuals with suitable inclusion criteria must be recruited. Patients can join from multiple locations such as SCRI - HealthOne Denver in Denver and Mary Crowley Cancer Research Centre situated in Dallas."
Answered by AI
What are the most frequent indications for TAK-676?
"TAK-676 is commonly prescribed to treat malignant neoplasms, however it can prove beneficial towards the management of other ailments like unresectable melanoma, microsatellite instability high and post chemotherapy disease advancement."
Answered by AI
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