BL-B01D1 for Lung Cancer
Recruiting in Palo Alto (17 mi)
+22 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: SystImmune Inc.
Disqualifiers: Severe heart disease, Autoimmune diseases, Hypertension, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.
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 have had chemotherapy, biological therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before starting the trial.
What data supports the effectiveness of the drug BL-B01D1, Izalontamab Brengitecan, for lung cancer?
The research on similar treatments, like sugemalimab, a PD-L1 inhibitor, shows promise in treating advanced non-small cell lung cancer (NSCLC) by using the body's immune system to fight cancer. This suggests that drugs targeting similar pathways, like BL-B01D1, could potentially be effective for lung cancer as well.
12345What makes the drug BL-B01D1 (Izalontamab Brengitecan) unique for treating lung cancer?
BL-B01D1 (Izalontamab Brengitecan) is unique because it combines targeted therapy with a novel mechanism that may differ from existing treatments, potentially offering a new option for patients with lung cancer who have not responded to standard therapies.
678910Eligibility Criteria
Adults over 18 with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that can't be removed by surgery, who've seen their cancer progress after treatment. They must have a life expectancy of at least 3 months, be in fairly good health otherwise (ECOG PS 0-1), and have a tumor that can be measured. People with autoimmune diseases, mixed lung cancers, recent other treatments or another cancer within the last 5 years, serious infections or heart disease aren't eligible.Inclusion Criteria
Sign informed consent
You have at least one identifiable abnormality that can be measured according to specific guidelines.
I am 18 years old or older.
+4 more
Exclusion Criteria
I have an active autoimmune or inflammatory disease.
I have severe lung disease or a history of tissue scarring in my lungs.
I haven't had serious blood clot issues needing treatment in the last 6 months.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants receive BL-B01D1 in a dose escalation format to determine the maximum tolerated dose
21-day cycles
Visits on Day 1 and Day 8 per cycle for Cohort A; Day 1 per cycle for Cohort B
Dose Finding
Participants receive BL-B01D1 to find the recommended dose for expansion
21-day cycles
Dose Expansion
Participants receive BL-B01D1 at the recommended dose to further evaluate safety and efficacy
21-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
One year
Participant Groups
The trial is testing BL-B01D1's safety and effectiveness for NSCLC patients whose cancer has spread and cannot be surgically removed. The study will monitor how well patients tolerate this drug and its impact on their lung cancer.
2Treatment groups
Experimental Treatment
Group I: BL-B01D1 administered Day 1 per cycleExperimental Treatment1 Intervention
BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks
Group II: BL-B01D1 administered Day 1 and Day 8 per cycleExperimental Treatment1 Intervention
BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
SystImmune Recruiting SiteHouston, TX
SystImmune Recruiting CenterDallas, TX
SystImmune Recruiting CenterPort Saint Lucie, FL
SystImmune Recruiting CenterGreenville, SC
More Trial Locations
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Who Is Running the Clinical Trial?
SystImmune Inc.Lead Sponsor
References
Phase I/II Trial of Immunotherapy With Durvalumab and Tremelimumab With Continuous or Intermittent MEK Inhibitor Selumetinib in NSCLC: Early Trial Report. [2021]Current strategies to improve clinical outcomes in v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog-mutant non-small-cell lung cancer (NSCLC) patients include mitogen-activated protein kinase kinase 1 inhibitor and programmed death (PD) 1 (PD-1)/PD ligand 1 (PD-L1) immune checkpoint blockade combinations. Experience from treatment of melanoma suggests that anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and anti-PD-1/PD-L1 combinations improve outcomes, but similar benefits remain to be seen for treatment of NSCLC. This report describes a single center, investigator-initiated phase I/II clinical trial to compare 2 combination schedules of intermittent or continuous selumetinib (AZD6244, ARRY-142886), tremelimumab (anti-CTLA-4), and durvalumab (anti-PD-L1) treatment with historical controls in patients with previously treated, unresectable NSCLC. Forty patients will be accrued at the University of Texas M.D. Anderson Cancer Center. Primary objectives include maximum tolerated dose (dose escalation phase) and progression-free survival (dose expansion phase). Secondary objectives include response rate according to Response Evaluation Criteria In Solid Tumors version 1.1, disease control rate, overall survival, safety, and duration of response. Exploratory objectives are to assess biomarkers of response and resistance on the basis of biopsies and peripheral blood taken before and after treatment using immune profiling, transcriptome, and protein readouts.
International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1. [2018]We evaluated whether motesanib (a selective oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3; platelet-derived growth factor receptor; and Kit) combined with carboplatin/paclitaxel improved overall survival (OS) versus chemotherapy alone in patients with nonsquamous non-small-cell lung cancer (NSCLC) and in the subset of patients with adenocarcinoma.
Sugemalimab, a novel PD-L1 inhibitor for treatment of advanced or metastatic non-small cell lung cancer. [2023]Nearly two-thirds of patients with non-small cell lung cancer (NSCLC) have locally advanced or metastatic disease at the time of diagnosis, and many patients with early-stage disease will eventually experience metastatic recurrence. In the absence of a known driver alteration, treatment of metastatic NSCLC is limited to immunotherapy with or without cytotoxic chemotherapy. For most patients with locally advanced unresectable NSCLC, the standard of care involves concurrent chemoradiation followed by consolidative immunotherapy. Several immune checkpoint inhibitors have been developed and approved for NSCLC in both the metastatic and adjuvant settings. This review will discuss sugemalimab, a novel programmed cell death 1 ligand 1 (PD-L1) inhibitor, for the treatment of advanced NSCLC.
Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer. [2021]The efficacy and safety of axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 in combination with pemetrexed and cisplatin was evaluated in patients with advanced non-squamous non-small-cell lung cancer (NSCLC).
Phase II study of topotecan and bevacizumab in advanced, refractory non--small-cell lung cancer. [2021]This clinical trial evaluated whether topotecan in combination with bevacizumab improved progression-free survival (PFS) in patients with advanced, refractory non--small-cell lung cancer in a second-line setting.
ZD6474--clinical experience to date. [2023]ZD6474 selectively targets two key pathways in tumour growth by inhibiting vascular endothelial growth factor (VEGF)-dependent tumour angiogenesis and epidermal growth factor (EGF)-dependent tumour cell proliferation and survival. Phase I clinical evaluation has shown ZD6474 to be generally well tolerated, with a pharmacokinetic profile appropriate for once-daily oral dosing. Phase II evaluation of ZD6474 at doses of 100-300 mg is ongoing in a range of patient types in single and combination regimens. These include three randomised studies of patients with non-small-cell lung cancer. In one of these trials, the efficacy of ZD6474 monotherapy is being compared with that of the EGF receptor tyrosine kinase inhibitor gefitinib (Iressa) in previously treated patients. In the other two trials, the efficacy of ZD6474 in combination with certain standard chemotherapy regimens is being compared with that of standard chemotherapy alone: one with carboplatin and paclitaxel in previously untreated patients, and the second with docetaxel in patients who progressed after platinum-containing therapy. The advent of novel molecular-targeted agents such as ZD6474 has necessitated a re-evaluation of conventional cancer study design in order to optimise appraisal of this new generation of anticancer agents. The specific considerations of the ZD6474 clinical programme are discussed.
Atezolizumab Plus Bevacizumab as First-line Treatment for Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer With High Tumor Mutation Burden: A Nonrandomized Controlled Trial. [2023]Antiangiogenic drug combinations with anti-programmed cell death 1 protein and anti-programmed cell death 1 ligand 1 (PD-L1) agents are a novel treatment option for lung cancer. However, survival remains limited, and the activity of these combinations for tumors with high tumor mutation burden (TMB) is unknown.
Efficacy of PD-1 Inhibitors Combined with Anti-Angiogenic Therapy in Driver Gene Mutation Negative Non-Small-Cell Lung Cancer with Brain Metastases. [2023]Anti-angiogenic therapy has proven effective in non-small-cell lung cancer (NSCLC) patients. The purpose of this study was to evaluate the efficacy of programmed cell death protein 1 (PD-1) inhibitors combined with anti-angiogenic therapy in patients with driver gene mutation negative NSCLC and brain metastases (BMs).
Amivantamab-Vmjw: A Novel Treatment for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutation after Progression on Platinum-Based Chemotherapy. [2023]This study is a comprehensive review of the clinical pharmacology, pharmacokinetics, efficacy, safety, and clinical applicability of amivantamab-vmjw for metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutation.
[Clinical Analysis of Docetaxel Combined with PD-1/PD-L1 Inhibitor in Second-line Treatment of Advanced Non-small Cell Lung Cancer]. [2022]Programmed cell death 1 or programmed cell death ligand 1 inhibitor (PD-1/PD-L1 inhibitor) and docetaxel, as the standard second-line treatments of advanced non-small cell lung cancer (NSCLC) patients, have limited effects. There are few studies on whether docetaxel combined with PD-1/PD-L1 inhibitor can increase the efficacy and make patients better benefit. The aim of this study is to evaluate the efficacy and safety of docetaxel combined with PD-1/PD-L1 inhibitor for the second-line treatment of stage IV NSCLC patients.