ZM008 Alone and With Pembrolizumab for Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Zumutor Biologics Inc.
Must not be taking: Immunosuppressants, Steroids
Disqualifiers: Uncontrolled brain metastasis, Active infection, Cardiovascular disease, Autoimmune disease, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Pembrolizumab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients should have recovered from previous treatment side effects and that certain conditions, like active infections or autoimmune diseases requiring high-dose steroids, may affect eligibility. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug ZM008 when used alone or with pembrolizumab for cancer?
What safety data exists for pembrolizumab in cancer treatment?
What makes the drug ZM008 unique compared to other cancer treatments?
ZM008 is being studied both alone and in combination with pembrolizumab, a drug that enhances the immune system's ability to fight cancer by targeting the PD-1 pathway. This combination could potentially offer a novel approach by leveraging pembrolizumab's known effectiveness in certain cancers, although specific details about ZM008's unique properties or mechanisms are not provided in the available research.1341011
Eligibility Criteria
This trial is for patients with various advanced solid tumors, like breast, lung, and prostate cancer, who have no standard treatment options left or can't tolerate them. It's not specified who can't join the trial.Inclusion Criteria
My cancer can be measured on scans.
My kidneys are functioning well enough (CrCL ≥30 mL/min).
Women of childbearing potential (WOCBP) and men with sexual partners who are WOCBP must adhere to contraceptive requirements
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Exclusion Criteria
I have not received any live vaccines in the last 30 days.
I have an autoimmune disease treated with drugs that affect my immune system.
I have had lung inflammation or scarring before.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Dose escalation of ZM008 as a single agent followed by combination with Pembrolizumab
Up to 36 months
Visits every 21 days for each cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
90 days
Treatment Details
Interventions
- ZM008 (Monoclonal Antibodies)
Trial OverviewThe study tests ZM008 alone and combined with Pembrolizumab to find safe doses in people whose cancers haven't responded to typical treatments. It's an early-stage (phase 1) dose-finding study.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Dose escalation of ZM008.
ZM008 is already approved in United States for the following indications:
🇺🇸 Approved in United States as ZM008 for:
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NEXT OncologyAustin, TX
NEXT OncologySan Antonio, TX
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Zumutor Biologics Inc.Lead Sponsor
References
Clinical application effect of Pembrolizumab in the treatment of advanced cutaneous malignant melanoma. [2021]To investigate the clinical application value of Pembrolizumab (PEM) in the treatment of advanced cutaneous malignant melanoma (ACMM).
Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score of 50% or Greater. [2022]In the randomized, open-label, phase III KEYNOTE-024 study, pembrolizumab significantly improved progression-free survival and overall survival (OS) compared with platinum-based chemotherapy in patients with previously untreated advanced non-small-cell lung cancer (NSCLC) with a programmed death ligand 1 tumor proportion score of 50% or greater and without EGFR/ALK aberrations. We report an updated OS and tolerability analysis, including analyses adjusting for potential bias introduced by crossover from chemotherapy to pembrolizumab.
Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study. [2023]Pembrolizumab is a programmed cell death protein-1 (PD-1) inhibitor used to treat advanced patients with non-small cell lung cancer (NSCLC) with a programmed cell death ligand-1 (PD-L1) tumour proportion score (TPS) ≥50. Further sub-division of TPS-based stratification has not been evaluated in the UK, although smoking-induced tumour mutational burden and the immunogenic effects of prior radiotherapy are suggested to improve response.
Evaluation of efficacy and safety of different pembrolizumab dose/schedules in treatment of non-small-cell lung cancer and melanoma: a systematic review. [2018]Pembrolizumab is a fully humanized anti-PD-1 agent currently approved for the treatment of advanced melanoma and pretreated non-small-cell lung cancer (NSCLC).
Clinical performance of endobronchial ultrasound-guided transbronchial needle aspiration for assessing programmed death ligand-1 expression in nonsmall cell lung cancer. [2018]Pembrolizumab was recently approved as a first line agent for metastatic NSCLC in patients with high programmed death-ligand 1 (PD-L1) expression.
Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. [2019]To evaluate safety, tolerability, and antitumor activity of pembrolizumab monotherapy in patients with programmed death ligand 1 (PD-L1)-expressing advanced ovarian cancer enrolled in the multicohort, phase Ib KEYNOTE-028 trial.
Clinical utility of pembrolizumab in the management of advanced solid tumors: an evidence-based review on the emerging new data. [2023]Pembrolizumab is a full-length human immunoglobulin G4 (IgG4) monoclonal antibody directed against the immune checkpoint PD-1 to remove its binding with PD-L1 and thus to restore an anti-tumor immune response of T cells. Pembrolizumab is one of the most advanced immune checkpoint inhibitors for cancer care. Apart from rare and serious adverse effects, its favorable tolerance profile enables to treat fragile patients who have often no other choice than best supportive care. The effective retained dose of pembrolizumab is a venous administration of 200 mg every 3 weeks until disease progression, intolerance or up to 24 months. Pembrolizumab has already proven its efficacy and thus obtained marketing authorization in so-called hot or hypermutated tumors or tumors expressing PD-L1 such as melanomas, non-small cell lung cancers, urothelial carcinomas, cervical cancer, etc. Pembrolizumab is also authorized in the United States in the treatment of mismatch repair-deficient tumors or with microsatellite instability. The current challenge is to expand its use in tumor types that are supposed to be less immunogenic, for example, by attempting to warm up the tumor microenvironment, or by combining pembrolizumab with other molecules. An acceptable toxicity profile of such combinations remains to explore. We review here the current indications of this drug, the main prognostic and predictive factors of its efficacy as well as the potential forthcoming indications.
Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. [2023]Pembrolizumab demonstrated robust antitumor activity and safety in the phase Ib KEYNOTE-001 study (NCT01295827) of advanced melanoma. Five-year outcomes in all patients and treatment-naive patients are reported herein. Patients whose disease progressed following initial response and who received a second course of pembrolizumab were also analyzed.
Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]We aimed to characterize the safety profile of pembrolizumab in advanced melanoma patients at our center to better reflect 'real-world' data on anti-PD-1 inhibitors.
Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. [2022]Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).
Pembrolizumab in lung cancer: current evidence and future perspectives. [2020]Pembrolizumab is a humanized monoclonal antibody against PD-1 capable of enhancing antitumor immune activity. The KEYNOTE-001 study showed that pembrolizumab has activity in advanced non-small-cell lung cancer patients and identified programmed death ligand 1 (PD-L1) as a companion test to select patients most likely to benefit from pembrolizumab. Five randomized clinical trials showed the efficacy of pembrolizumab in non-small-cell lung cancer: in second-line setting PD-L1 ≥1% (KEYNOTE-010), in first-line setting PD-L1 ≥50% (KEYNOTE-024 and KEYNOTE-042) and in first-line setting in combination with platinum doublets, any expression of PD-L1 (KEYNOTE-189 and KEYNOTE-407). Future challenges are the identification of the role of pembrolizumab in adjuvant, neoadjuvant, locally advanced disease or oncogene-addicted patients, in combination with radiotherapy or other biological agents.