TAB004 + Toripalimab for Solid Cancers
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: TopAlliance Biosciences
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary objective is to assess the safety and tolerability of TAB004 as monotherapy and in combination with toripalimab in subjects with selected advanced solid malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose.
The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB004 monotherapy and in combination with toripalimab and to describe the PK profile of toripalimab when administered with TAB004, 2) evaluate antitumor activity of TAB004 monotherapy and in combination with toripalimab; and 3) determine the immunogenicity of TAB004 monotherapy and in combination with toripalimab and to determine the immunogenicity of toripalimab when administered with TAB004.
The exploratory objectives are to: 1) evaluate pharmacodynamic effects of TAB004 on its target receptor BTLA, as well as effects on the immune system; 2) evaluate biomarkers that may correlate with activity of TAB004 as monotherapy and in combination with toripalimab; 3) evaluate the utility of BTLA ligand, herpesvirus-entry mediator (HVEM), and additional exploratory biomarkers that could aid in selection of appropriate subjects for TAB004 monotherapy and in combination with toripalimab.
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any concurrent anti-cancer therapy, and you should not have used immunosuppressive medication within 2 weeks before starting the trial, except for certain corticosteroids. It's best to discuss your specific medications with the trial team.
Is the drug TAB004, Toripalimab a promising treatment for solid cancers?Yes, TAB004, Toripalimab is a promising treatment for solid cancers because it is being studied for its potential to help the immune system fight cancer cells, which could lead to better outcomes for patients.12345
What safety data is available for the treatment TAB004 + Toripalimab for solid cancers?The safety data for toripalimab, a PD-1 inhibitor, has been evaluated in several studies. A phase I study assessed its safety in patients with advanced or recurrent malignancies, indicating it was generally well-tolerated. A systematic review and meta-analysis of randomized controlled trials also evaluated the safety of toripalimab in combination therapies, providing a reference for its clinical use. Additionally, phase II trials in esophageal squamous cell carcinoma and non-small cell lung cancer have investigated the safety of toripalimab combined with chemoradiotherapy and chemotherapy, respectively, showing promising safety profiles.678910
What data supports the idea that TAB004 + Toripalimab for Solid Cancers is an effective treatment?The available research shows that toripalimab, when combined with other treatments, has shown promising results in treating certain types of cancer. For example, in non-small cell lung cancer, combining toripalimab with chemotherapy has shown positive outcomes. Additionally, in esophageal squamous cell carcinoma, toripalimab combined with chemoradiotherapy has been effective in treating advanced cases. These studies suggest that toripalimab can be a beneficial part of cancer treatment plans, especially when used with other therapies.678910
Eligibility Criteria
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.Inclusion Criteria
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.
Exclusion Criteria
I have a history of tuberculosis.
I do not have any uncontrolled illnesses.
I have or had inflammatory bowel disease.
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 received a live vaccine within 28 days before joining the study or plan to within 30 days after getting TAB004.
My asthma is moderate or severe.
I have or had severe lung inflammation caused by drugs.
I have brain or spinal cord metastases that are untreated or still need treatment.
I still have side effects from previous cancer treatments.
Treatment Details
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.
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
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Maryland Medical CenterBaltimore, MD
University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer CenterDallas, TX
Northwell HealthNew Hyde Park, NY
Washington UniversitySaint Louis, MO
More Trial Locations
Loading ...
Who is running the clinical trial?
TopAlliance BiosciencesLead Sponsor
Shanghai Junshi Bioscience Co., Ltd.Collaborator
TopAlliance Biosciences, Inc.Collaborator
CTI Clinical Trial and Consulting ServicesCollaborator
References
Phase I/II trial of tremelimumab in patients with metastatic melanoma. [2022]Cytotoxic T lymphocyte-associated antigen 4 (CTLA4) blockade with tremelimumab (CP-675,206), a fully human anti-CTLA4 monoclonal antibody, was tolerated and demonstrated antitumor activity in a single dose, dose-escalation phase I trial in patients with solid tumors. This phase I/II trial was conducted to examine safety of multiple doses of tremelimumab, to further assess efficacy, and to identify an appropriate dosing regimen for further development.
Tremelimumab in combination with exemestane in patients with advanced breast cancer and treatment-associated modulation of inducible costimulator expression on patient T cells. [2022]Tremelimumab is a fully human monoclonal antibody specific for CTL-associated antigen 4 (CTLA4) with single-agent activity in certain tumors but has not been evaluated in patients with breast cancer.
Phase II study of the anti-cytotoxic T-lymphocyte-associated antigen 4 monoclonal antibody, tremelimumab, in patients with refractory metastatic colorectal cancer. [2022]Safety and efficacy of tremelimumab (CP-675,206), a fully human anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA4) monoclonal antibody, were assessed in patients with treatment-refractory colorectal cancer.
Tremelimumab. [2023]Tremelimumab (CP 675206; CP-675; CP-675,206; CP-675206; Ticilimumab) is a fully human IgG2 anitbody, which is directed against human cytotoxic T lymphocyte-associated antigen 4 (CTLA4). It is being developed by Pfizer for the treatment of various cancers. It is currently in worldwide phase III development for malignant melanoma, phase II development for colorectal cancer, gastrointestinal cancer, gynecological cancer, and non-small cell lung cancer in the US and other countries, and is also being investigated for prostate, breast, and pancreatic cancer in various countries. This review discusses the key development milestones and therapeutic trials of this drug.
Blood mRNA expression profiling predicts survival in patients treated with tremelimumab. [2022]Tremelimumab (ticilimumab, Pfizer), is a monoclonal antibody (mAb) targeting cytotoxic T lymphocyte-associated antigen-4 (CTLA-4). Ipilimumab (Yervoy, BMS), another anti-CTLA-4 antibody, is approved by the U.S. Federal Drug Administration (FDA). Biomarkers are needed to identify the subset of patients who will achieve tumor control with CTLA-4 blockade.
Safety and clinical efficacy of toripalimab, a PD-1 mAb, in patients with advanced or recurrent malignancies in a phase I study. [2020]This is a first-in-human phase I study investigating the safety and efficacy of toripalimab, a humanized monoclonal antibody against the programmed cell death-1 (PD-1) receptor, in Chinese patients with advanced or recurrent malignant tumor refractory to standard treatment.
Neoadjuvant toripalimab plus platinum-paclitaxel chemotherapy in stage II-III non-small cell lung cancer: a single-center, single-arm, phase I study in China. [2023]Neoadjuvant and adjuvant immune checkpoint inhibitor treatments for non-small cell lung cancer (NSCLC) patients with resectable disease have presented promising results. This is a phase I study to evaluate the safety and efficacy of neoadjuvant toripalimab in combination with chemotherapy for NSCLC.
Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial. [2023]Toripalimab is a PD-1 inhibitor that is approved for the treatment of advanced oesophageal squamous cell carcinoma, but its efficacy in locally advanced disease is unclear. We administered toripalimab with definitive chemoradiotherapy to patients with unresectable locally advanced oesophageal squamous cell carcinoma, and aimed to investigate the activity and safety of this regimen, and potential biomarkers.
A phase II clinical trial of toripalimab combined with neoadjuvant chemoradiotherapy in locally advanced esophageal squamous cell carcinoma (NEOCRTEC1901). [2023]To evaluate the efficacy and safety of toripalimab combined with neoadjuvant chemoradiotherapy (NCRT) for locally advanced esophageal squamous cell carcinoma (ESCC).
Clinical outcomes and immunological evaluation of toripalimab combination for cancer treatment: A systematic review and meta-analysis of randomized controlled trials. [2023]This study was performed to evaluate the efficacy, safety and immunological function of toripalimab combination therapy, aiming to provide a reference for the clinical combined use of toripalimab and the development of subsequent indications for cancer treatment.