What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Treatments for solid tumors, including monoclonal antibodies like the anti-CD93 DCSZ11, often cause immune-related adverse effects such as fatigue, rash, diarrhea, and pruritus. Severe side effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and myocarditis. Chemotherapy, commonly used alongside monoclonal antibodies, can result in nausea, vomiting, fatigue, neutropenia, and neuropathy. Targeted therapies may lead to hypertension, hand-foot syndrome, and liver toxicity.

What prior FDA approvals exist?

Several monoclonal antibodies have been FDA-approved for the treatment of solid tumors. For instance, pembrolizumab (Keytruda) and nivolumab (Opdivo) are anti-PD-1 monoclonal antibodies approved for various solid tumors, including non-small cell lung cancer (NSCLC) and melanoma. Atezolizumab (Tecentriq), an anti-PD-L1 antibody, is approved for NSCLC and urothelial carcinoma. These treatments work by targeting immune checkpoints to enhance the body's immune response against cancer cells. While DCSZ11 is an anti-CD93 monoclonal antibody, these approved therapies share a common approach of utilizing the immune system to combat solid tumors.

What other types of research exist?

Promising alternatives to DCSZ11 for solid tumor patients include: 1) Atezolizumab, an anti-PD-L1 antibody, which has shown improved survival outcomes in combination with chemotherapy for small cell lung cancer and renal cell carcinoma. 2) Durvalumab, another anti-PD-L1 antibody, which has demonstrated efficacy in combination with platinum-etoposide for small cell lung cancer. 3) Pembrolizumab, an anti-PD-1 antibody, which has been effective in combination with chemotherapy for non-small cell lung cancer and gastric cancer. These therapies have shown significant improvements in overall survival and progression-free survival in clinical trials.

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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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3150

Do I qualify?Apply below to find out

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.

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