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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 3 years
Awards & highlights
Study Summary
This trial is testing a new antibody drug to fight cancer in people with advanced or spread cancer.
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.Check my eligibility
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.See study design
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 ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a: Frequency and severity of treatment emergent adverse events
Phase 1a: Incidence of dose limiting toxicites (DLTs)
Phase 1b: Overall response rate (ORR) per Investigator-assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)
Secondary outcome measures
Phase 1 a and b: Disease control rate (DCR) as determined per Investigator assessment by RECIST v1.1 and iRECIST.
Phase 1 a and b: Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAbs) against DCSZ11
Phase 1 a and b: Overall survival (OS)
+5 moreTrial 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 2
~2010
Find a Location
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any of the slots for this research trial still available?
"This clinical trial is presently open to enrollment, as per the information on clinicaltrials.gov. The initial posting was June 28th 2023 and it has been recently edited that same day."
Answered by AI
How many individuals are being included in this research experiment?
"Affirmative. According to clinicaltrials.gov, this medical research project is actively soliciting participants and was last updated on June 28th 2023. The experiment requires 96 patients across one location to be enrolled by investigators."
Answered by AI
What have been the outcomes of Part 2B Dose Expansion trials with regards to patient safety?
"Since this is a Phase 1 trial, there is only limited data on Part 2B Dose Expansion's efficacy and safety. Therefore, it was scored with a 1 by our team at Power."
Answered by AI
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