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Monoclonal Antibodies
TAB004 + Toripalimab for Solid Cancers
Phase 1
Recruiting
Research Sponsored by TopAlliance Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing potential defined as not surgically sterile or postmenopausal
Hemoglobin 8.0 g/dL within first 2 weeks prior to first dose of TAB004 (are not requiring a transfusion within 14 days prior to dosing)
Must not have
Known history of tuberculosis
Uncontrolled intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
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.
Who is the study for?
Adults over 18 with advanced solid tumors or lymphoma that worsened after treatment can join. They must have measurable disease, be in fairly good health (ECOG status of 0 or 1), and expect to live at least three more months. Participants need proper organ function, not be pregnant, use effective birth control, and agree to provide biopsy samples. Those who've had certain treatments or conditions recently can't participate.
What is being tested?
The trial is testing TAB004 alone and with toripalimab for safety and the best dose against advanced cancers. It will also look at how the body processes these drugs, their effects on tumors, immune response they trigger, and explore biomarkers related to BTLA receptors involved in immune system regulation.
What are the potential side effects?
Possible side effects include reactions where the drug enters the body, changes in blood tests reflecting organ function like liver or kidney issues, fatigue, potential impact on infection risk due to immune system effects; specific risks will depend on individual patient factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can still have children.
Select...
My hemoglobin level is at least 8.0 g/dL and I haven't needed a blood transfusion in the last 14 days.
Select...
My cancer is advanced, cannot be surgically removed, and has worsened after treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of tuberculosis.
Select...
I do not have any uncontrolled illnesses.
Select...
I have or had inflammatory bowel disease.
Select...
I have or had an autoimmune disease.
Select...
I am not currently receiving any cancer treatments.
Select...
I stopped previous immune therapy because of its side effects.
Select...
I have not had any serious bleeding in the last 2 weeks.
Select...
I have not received a live vaccine within 28 days before joining the study or plan to within 30 days after getting TAB004.
Select...
My asthma is moderate or severe.
Select...
I have or had severe lung inflammation caused by drugs.
Select...
I have brain or spinal cord metastases that are untreated or still need treatment.
Select...
I still have side effects from previous cancer treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary study objectives
Accumulation after multiple dose in injection of TAB004 and for toripalimab
Apparent volume of distribution (V) after single dose injection of TAB004 and for toripalimab
Apparent volume of distribution of steady state (Vss) after multiple dose injection of TAB004 and for toripalimab
+14 moreOther study objectives
Correlation analysis of HVEM expression of tumor and DCR
Correlation analysis of HVEM expression of tumor and ORR
Correlation analysis of HVEM expression of tumor and OS
+1 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: TAB004 70mg and Torpalimab 240mg repeat dose every 21 days up to 2 yearsExperimental Treatment2 Interventions
Group II: TAB004 500mg and Torpalimab 240mg repeat dose every 21 days up to 2 yearsExperimental Treatment2 Interventions
Group III: TAB004 3 mg/kg repeat dose every 21 days up to 2 yearsExperimental Treatment1 Intervention
Group IV: TAB004 20mg and Torpalimab 240mg repeat dose every 21 days up to 2 yearsExperimental Treatment2 Interventions
Group V: TAB004 200mg repeat dose every 21 days up to 2 yearsExperimental Treatment1 Intervention
Group VI: TAB004 200mg and Torpalimab 240mg repeat dose every 21 days up to 2 yearsExperimental Treatment2 Interventions
Group VII: TAB004 10 mg/kg repeat dose every 21 days up to 2 yearsExperimental Treatment1 Intervention
Group VIII: TAB004 1 mg/kg repeat dose every 21days up to 2 yearsExperimental Treatment1 Intervention
Group IX: TAB004 0.3 mg/kg repeat dose every 21 days up to 2 yearsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Toripalimab
2017
Completed Phase 3
~1240
Find a Location
Who is running the clinical trial?
TopAlliance BiosciencesLead Sponsor
Shanghai Junshi Bioscience Co., Ltd.OTHER
114 Previous Clinical Trials
27,269 Total Patients Enrolled
TopAlliance Biosciences, Inc.UNKNOWN
2 Previous Clinical Trials
198 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
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.
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