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Monoclonal Antibodies
DCSZ11 + Pembrolizumab for Advanced Cancer
Phase 1
Recruiting
Research Sponsored by DynamiCure Biotechnology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include allergic reactions to the drug components, immune-related issues due to monoclonal antibodies like inflammation in organs or skin problems, fatigue from treatment burden and possible complications related to underlying health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2850
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Monoclonal antibodies, such as DCSZ11, target specific antigens on the surface of cancer cells, in this case, CD93, which is involved in tumor angiogenesis and growth. By binding to these antigens, these antibodies can inhibit tumor growth, induce cancer cell death, and enhance the immune system's ability to attack cancer cells.
This mechanism is crucial for solid tumor patients as it offers a targeted approach, potentially leading to more effective treatments with fewer side effects compared to traditional chemotherapy. Additionally, combining monoclonal antibodies with other therapies can improve overall treatment efficacy and patient outcomes.
Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.
Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.
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Who is running the clinical trial?
DynamiCure BiotechnologyLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am on strong medication for an autoimmune disease, not including hormone therapy.I have had a transplant of tissue or an organ from another person.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.I understand the study rules and have signed the consent form.I agree to have a biopsy before and during treatment, and it's safe for me.I haven't had blood clots or lung artery blockages in the last month, or I'm on stable blood thinner treatment.I have had lung inflammation or lung disease that needed steroids.I had major radiotherapy less than 4 weeks ago or small area treatment less than a week ago.I have lung inflammation not caused by an infection.I haven't had cancer in the last 3 years, except for certain treated or localized types.I am 18 years old or older.I have severe protein in my urine or nephrotic syndrome.I am currently pregnant or breastfeeding.I haven't had serious heart issues or uncontrolled high blood pressure in the last 6 months.My advanced cancer has not responded to or worsened after standard treatment.I haven't had a stroke, blood clot, or serious bleeding in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1a Dose Escalation Combination
- Group 2: Phase 1b Dose Expansions
- Group 3: Phase 1a Dose Escalation Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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