DCSZ11 + Pembrolizumab for Advanced Cancer
Recruiting in Palo Alto (17 mi)
+34 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: DynamiCure Biotechnology
Must not be taking: Immunosuppressants, Anticancer treatments
Disqualifiers: Second malignancy, Thrombotic events, Heart failure, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial is testing DCSZ11, a drug that helps the immune system attack cancer cells by targeting a specific protein. It is aimed at patients with advanced or metastatic solid tumors. The study will determine the best dose and assess its effectiveness both alone and in combination with another drug, pembrolizumab, which has shown efficacy in various cancers.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have received systemic anticancer treatments or investigational products within 14 days before the first dose of the study drug.
What data supports the effectiveness of the drug DCSZ11 + Pembrolizumab for advanced cancer?
Pembrolizumab has shown strong antitumor activity and improved survival rates in various advanced cancers, including non-small-cell lung cancer and tumors with specific genetic features, when used alone or with other drugs. This suggests it could be effective in combination with DCSZ11 for advanced cancer.
12345What safety data exists for Pembrolizumab in humans?
Pembrolizumab is generally considered safe for treating advanced cancers, but some patients may experience immune-related side effects, such as interstitial nephritis (a type of kidney inflammation). It has been studied in various cancers, including non-small cell lung cancer, and is usually well-tolerated, though complications can occur.
14678What makes the drug DCSZ11 + Pembrolizumab unique for advanced cancer?
The combination of DCSZ11 with pembrolizumab is unique because it pairs a potentially novel agent (DCSZ11) with pembrolizumab, an established immunotherapy that works by blocking the PD-1 pathway to help the immune system attack cancer cells. This combination may offer a new approach for treating advanced cancers, especially if DCSZ11 has a different mechanism or targets compared to existing treatments.
145910Eligibility Criteria
Adults with advanced or metastatic solid tumors, such as colorectal, lung, breast cancer and more, who have tried all other active treatments without success. They must be in a stable condition with good organ function and agree to use contraception. Those with severe heart issues, uncontrolled diseases like pulmonary conditions or infections, recent major surgeries or certain blood clots are excluded.Inclusion Criteria
I can take care of myself and am up and about more than half of my waking hours.
My recent tests show my organs and bone marrow are functioning well.
I am a man who agrees to not have sex or use birth control and not donate sperm.
+6 more
Exclusion Criteria
I haven't taken any cancer drugs or been in a trial for at least 14 days.
My surgical wounds from recent surgery are fully healed and not infected.
I stopped immunotherapy due to severe side effects.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants receive escalating doses of DCSZ11 as monotherapy and in combination with pembrolizumab to assess safety and tolerability
Varies
Multiple visits to the clinic
Dose Expansion
Participants receive selected doses of DCSZ11 in combination with pembrolizumab to further investigate safety, tolerability, and antitumor activity
Varies
Multiple visits to the clinic
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Participant Groups
The trial is testing DCSZ11 alone and combined with Pembrolizumab in patients with various types of solid tumors that haven't responded to standard therapies. It's an early-phase study looking at how well these drugs work together for treating cancer.
3Treatment groups
Experimental Treatment
Group I: Phase 1b Dose ExpansionsExperimental Treatment2 Interventions
Dose expansion to further investigate the safety, tolerability, and preliminary evidence of antitumor activity of the combination with pembrolizumab in select tumor indications.
Group II: Phase 1a Dose Escalation MonotherapyExperimental Treatment1 Intervention
Dose escalation to investigate the safety and tolerability of DCSZ11.
Group III: Phase 1a Dose Escalation CombinationExperimental Treatment2 Interventions
Dose escalation to investigate safety and tolerability, and determine DCSZ11 Phase 1b doses in combination with pembrolizumab.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ohio State UniversityColumbus, OH
Yale Cancer CenterNew Haven, CT
University of ColoradoAurora, CO
Sarah Cannon Research Institute Denver HealthoneDenver, CO
More Trial Locations
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Who Is Running the Clinical Trial?
DynamiCure BiotechnologyLead Sponsor
References
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).
Phase I Study of Pembrolizumab (MK-3475; Anti-PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors. [2022]This phase I study evaluated the safety, maximum tolerated dose, antitumor activity, and pharmacokinetics and pharmacodynamics of pembrolizumab in patients with advanced solid tumors.
Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC. [2021]In cohort G of KEYNOTE-021 (NCT02039674), first-line pembrolizumab plus pemetrexed-carboplatin significantly improved the objective response rate and progression-free survival versus chemotherapy alone with manageable toxicity in advanced nonsquamous NSCLC. We report the long-term outcomes from this study.
Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study. [2022]Pembrolizumab demonstrated durable antitumor activity in 233 patients with previously treated advanced microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors in the phase II multicohort KEYNOTE-158 (NCT02628067) study. Herein, we report safety and efficacy outcomes with longer follow-up for more patients with previously treated advanced MSI-H/dMMR noncolorectal cancers who were included in cohort K of the KEYNOTE-158 (NCT02628067) study.
Real-world efficacy and safety of pembrolizumab in patients with non-small cell lung cancer: a retrospective observational study. [2022]Pembrolizumab, a humanized immunoglobulin monoclonal antibody directed against the programmed cell death 1 receptor, demonstrated robust efficacy and a manageable safety profile across multiple tumor types in clinical trials.
Pembrolizumab for the treatment of PD-L1 positive advanced or metastatic non-small cell lung cancer. [2020]The emergence of immune checkpoint inhibitors marked an important advancement in the development of cancer therapeutics. Pembrolizumab is a selective humanized IgG4 kappa monoclonal antibody that inhibits the programmed death-1 (PD-1) receptor, an integral component of immune checkpoint regulation in the tumor microenvironment. The drug is currently approved by the Food and Drug Administration for the treatment of advanced melanoma and metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC). Several published studies demonstrate that single-agent pembrolizumab is safe and has efficacy in patients with NSCLC. Many ongoing protocols are investigating the role of pembrolizumab in combination with other agents in lung cancer and various other cancer types. We review the available data on pembrolizumab in NSCLC and examine the role of potential predictive biomarkers of response to therapy.
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.
Interstitial nephritis with pembrolizumab: A case report and review. [2021]Pembrolizumab is a monoclonal antibody approved for adult patients with advanced non-small-cell lung cancer (NSCLC). Although immune related adverse events are considered to be well tolerated, complications may occur and discontinuation of the treatment could be required.
Pembrolizumab in advanced osteosarcoma: results of a single-arm, open-label, phase 2 trial. [2022]To evaluate the activity and safety of the PD-1 antibody pembrolizumab in adult patients with advanced osteosarcoma.
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).