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TAB004 + Toripalimab for Solid Cancers
Study Summary
This trial is studying a drug called TAB004 given alone or with another drug called toripalimab to see if it is safe and tolerable in treating subjects with selected advanced solid malignancies.
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 have a history of tuberculosis.My organs and bone marrow are working well.I do not have any uncontrolled illnesses.I have or had inflammatory bowel disease.You have a history of severe allergic reactions (anaphylaxis), or uncontrolled eczema or asthma.My platelet count is at least 75,000 and I haven't needed a platelet transfusion in the last 5 days.I have or had an autoimmune disease.I am not currently receiving any cancer treatments.I stopped previous immune therapy because of its side effects.I have not had any serious bleeding in the last 2 weeks.I have not been treated with anti-BTLA or anti-HVEM antibodies.I am mostly active and my doctor believes I have at least 3 months to live.You have received a bone marrow or solid organ transplant in the past.I am 18 years old or older.I have not received a live vaccine within 28 days before joining the study or plan to within 30 days after getting TAB004.I am mostly active and my doctor believes I have at least 3 months to live.Nothing will interfere with my study participation or affect the results.Your blood test shows that you have enough infection-fighting cells called lymphocytes.I have no other cancers or have been cancer-free for 3 years.My asthma is moderate or severe.You are able to understand and willing to sign a document called the "Informed Consent Form" that explains the study.Your bilirubin levels (a substance produced by your liver) must not be too high, except if you have a condition called Gilbert's syndrome, in which case slightly higher levels are allowed.My cancer is advanced, and I've had at least one treatment for it.I am a woman who can still have children.My hemoglobin level is at least 8.0 g/dL and I haven't needed a blood transfusion in the last 14 days.My cancer is advanced, cannot be surgically removed, and has worsened after treatment.I am 18 years old or older.I have or had severe lung inflammation caused by drugs.You have a detectable medical condition that can be measured using specific guidelines.I am using birth control to prevent pregnancy.You are pregnant or breastfeeding.I have not had major surgery in the last 28 days.I have not taken immunosuppressive drugs in the last 2 weeks.I have brain or spinal cord metastases that are untreated or still need treatment.I still have side effects from previous cancer treatments.You are willing to allow the collection of tissue samples through a biopsy.You must have a certain amount of a type of white blood cell called neutrophils in your blood.
- Group 1: TAB004 10 mg/kg repeat dose every 21 days up to 2 years
- Group 2: TAB004 70mg and Torpalimab 240mg repeat dose every 21 days up to 2 years
- Group 3: TAB004 200mg repeat dose every 21 days up to 2 years
- Group 4: TAB004 20mg and Torpalimab 240mg repeat dose every 21 days up to 2 years
- Group 5: TAB004 500mg and Torpalimab 240mg repeat dose every 21 days up to 2 years
- Group 6: TAB004 200mg and Torpalimab 240mg repeat dose every 21 days up to 2 years
- Group 7: TAB004 0.3 mg/kg repeat dose every 21 days up to 2 years
- Group 8: TAB004 1 mg/kg repeat dose every 21days up to 2 years
- Group 9: TAB004 3 mg/kg repeat dose every 21 days up to 2 years
- 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
Has TAB004 undergone the necessary testing to be cleared by the FDA?
"TAB004's safety is still being assessed in clinical trials and, as such, it only received a score of 1."
What other experiments have been done that use TAB004?
"The TAB004 medication was first studied in 2017 at Beijing Cancer Hospital. However, since then, there have been 7 completed clinical trials. Presently, 156 active trials are underway, with a large concentration being performed in Birmingham, Alabama."
Is this research study looking for more participants?
"Yes, this trial is still open and looking for participants. The listing on clinicaltrials.gov shows that the original posting was on October 30th, 2019, and the most recent update was on June 1st, 2022."
How many people are included in this experiment at the most?
"In order to carry out this clinical trial, we require 499 willing participants that fit the bill in terms of specified inclusion criteria. University of Alabama at Birmingham in Birmingham, Alabama and Massachusetts General Hospital in Boston, Massachusetts are two of the many hospitals where patients can take part in this trial."
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