TAB004 + Toripalimab for Solid Cancers
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: TopAlliance Biosciences
Must not be taking: Immunosuppressants, Anticancer therapies
Disqualifiers: Autoimmune diseases, Active infections, others
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.
Will I have to stop taking my current medications?
The trial does not specify if you must 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 low-dose corticosteroids.
What data supports the effectiveness of the drug toripalimab for treating solid cancers?
Research shows that toripalimab, when combined with other treatments, has shown promising results in treating various cancers, including non-small cell lung cancer and esophageal squamous cell carcinoma. These studies suggest that toripalimab can be effective in enhancing the body's immune response to fight cancer.
12345Is the combination of TAB004 and Toripalimab safe for humans?
Toripalimab, a part of the treatment, has been studied in various trials and is generally considered safe, though it can have side effects like fatigue, rash, and changes in liver function. These studies have been conducted in patients with different types of cancer, and while the specific combination with TAB004 hasn't been detailed, the existing data on Toripalimab suggests it is generally safe for human use.
12345What makes the drug TAB004 + Toripalimab unique for treating solid cancers?
TAB004 + Toripalimab is unique because it combines two components: TAB004, which targets a specific protein on cancer cells, and Toripalimab, an immune checkpoint inhibitor that helps the immune system attack cancer cells. This combination aims to enhance the body's immune response against solid tumors, offering a novel approach compared to traditional treatments.
678910Eligibility 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.
Participant Groups
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
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.
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.
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.
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 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.
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.
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.
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.