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TTX-080 +/− Cetuximab/Pembrolizumab for Cancer
Study Summary
This trial is testing a new drug (TTX-080) to see if it is safe and effective in treating cancer. The drug is being tested alone and in combination with two other drugs (pembrolizumab and cetuximab) to see if it improves treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I'm sorry, I don't understand what you mean by "Abbreviated." Could you please provide more context or information?I am 18 or older and can agree to participate.I do not have any other active cancers or serious illnesses that are not under control.I am mostly active and my doctor expects me to live at least 12 more weeks.I am currently on high-dose steroids or other drugs that weaken my immune system.My cancer is advanced and has spread to other parts.
- Group 1: Phase 1b, Dose Expansion: TTX-080 as monotherapy OR in combination with pembrolizumab
- Group 2: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), no prior anti-EGFR therapy
- Group 3: Phase 1b, Dose Expansion: TTX-080 monotherapy (CRC)
- Group 4: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), prior anti-EGFR therapy
- Group 5: Phase 1a, Monotherapy Dose Escalation
- Group 6: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (HNSCC)
- Group 7: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (HNSCC)
- Group 8: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (NSCLC)
- Group 9: Phase 1b, Dose Expansion: TTX-080 monotherapy (NSCLC)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are new participants in this trial being accepted at present?
"Clinicaltrials.gov shows that this trial is presently recruiting participants, with the initial post being on July 14th 2020 and its latest update occurring November 30th 2022."
How many institutions are in charge of this research venture?
"The 36 sites associated with this medical trial include Texas Oncology - Dallas in Dallas, Zangmeister Cancer Center in Columbus and Hoag Memorial Hospital in Newport Beach. Additionally, there are numerous other areas participating."
Is there any potential danger associated with TTX-080?
"As this is an early-stage trial, there is limited research supporting both the safety and efficacy of TTX-080. Consequently, our team assigned it a score of 1 on our risk scale."
Are there any precedent studies involving TTX-080?
"At the moment, 149 trials for TTX-080 are in Phase 3 and 1069 have been opened overall. With a majority of these studies situated in Scottsdale, Arizona, there is an expansive network with 40864 sites conducting research on this medication."
How many individuals are participating in this trial at its maximum capacity?
"This trial mandates the participation of 240 volunteers fulfilling its criteria for inclusion. Those interested can join from multiple locations, such as Texas Oncology - Dallas in Dallas or Zangmeister Cancer Center located in Columbus."
What medical conditions is TTX-080 regularly utilized to treat?
"TTX-080 is a recommended therapeutic option for unresectable melanoma, as well as conditions such as microsatellite instability high, heightened risk of relapse and irinotecan intolerance."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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