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TAK-186 for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Maverick Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Tumor Histology Types: Dose escalation will begin by initially enrolling participants with histologically proven, unresectable, locally advanced or metastatic solid tumors that based on prior literature reports are considered to express epidermal growth factor receptor (EGFR).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 13 months
Awards & highlights
Study Summary
This trial tests a new cancer drug to see if it's safe and how it works. Participants may receive treatment for up to 13 months and follow-up visits for up to 48 weeks.
Who is the study for?
Adults with advanced or metastatic cancer that can't be removed, who have a life expectancy of at least 12 weeks and measurable disease. They must be in relatively good health (ECOG ≤1), have acceptable blood test results, and provide informed consent. Specific types of cancers like NSCLC, HNSCC, and CRC are included if they've progressed after standard treatments.Check my eligibility
What is being tested?
The trial is testing TAK-186 (MVC-101) for safety and effectiveness in treating various advanced cancers. Participants will receive the treatment for up to 13 months with follow-ups at specified intervals to monitor their response.See study design
What are the potential side effects?
While specific side effects of TAK-186 (MVC-101) aren't listed here, common side effects from cancer treatments may include fatigue, nausea, inflammation at the injection site, allergic reactions, changes in blood counts leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My tumor is advanced or metastatic and likely has EGFR.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 13 months
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 with Cytokine Release Syndrome/Infusion Reactions
Therapeutic procedure
Number of Participants with a Dose-Limiting Toxicity (DLT)
Secondary outcome measures
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-186
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-186
AUCtau: Area Under the Plasma Concentration-time Curve for a Dosing Interval for TAK-186
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Escalation PhaseExperimental Treatment1 Intervention
TAK-186 initial 60 minutes infusion and 30 minutes subsequent infusions on Day 1 of every week in Dose Escalation Phase. Participants may receive additional treatment with TAK-186. Dose escalation will be carried out in sequential cohorts of escalating doses.
Group II: Cohort Expansion Phase: NSCLCExperimental Treatment1 Intervention
Participants with non-small cell lung cancer (NSCLC) will be randomized to receive low dose or high dose of RDE of TAK-186 infusion on Day 1 of every week during Dose Expansion Phase of the study. Participants may receive additional treatment with TAK-186. Based on the results for this cohort additional cohorts for HNSCC and CRC, may be enrolled.
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Who is running the clinical trial?
Maverick Therapeutics, IncLead Sponsor
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,686 Total Patients Enrolled
Daniela Buglio, MD, PhDStudy ChairMaverick Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by scans and hasn't been treated with radiation in the area to be measured.I am a woman able to have children, not pregnant, and agree to use 2 birth control methods during the study.I am willing to provide tumor samples before and during treatment if my cancer is in a safe location for biopsy.I am fully active or can carry out light work.My tumor is advanced or metastatic and likely has EGFR.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort Expansion Phase: NSCLC
- Group 2: Dose Escalation Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this trial currently underway?
"Per the information posted to clinicaltrials.gov, this research is still recruiting participants for its trials. It was originally published on March 8th 2021 and then revised most recently on August 31st 2023."
Answered by AI
What is the maximum capacity for enrollment in this research project?
"Affirmative. The information posted on clinicaltrials.gov evidences that this research is presently recruiting participants. This experiment, which was initially published on March 8th 2021, necessitates the recruitment of 228 volunteers from 7 separate medical centres."
Answered by AI
Are there any health care facilities in the US that are implementing this clinical trial?
"This clinical study is taking place in various medical centres throughout Australia, such as The Alfred Hospital located in Melbourne's Victoria district, Peter MacCallum Cancer Centre situated on Grattan Street Parkville, and Scientia Clinical Research Limited based at the Bright Building of Corner High & Avoca Street in Bedford Park South Australia. Additionally, there are 7 additional sites participating."
Answered by AI
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