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Monoclonal Antibodies

DK210 for Cancer

Phase 1

Recruiting

Research Sponsored by DEKA Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Progressive disease (PD) at study entry defined as one or more of the following criteria: Clinical PD with performance decline, clinical symptoms and/or observed tumor growth, PD documented with imaging showing at least 20% growth (largest diameter) and/or new lesions

Subjects have failed one or more lines of systemic therapy and have not been operated on or receiving anti-cancer medication for at least 4 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from initiation of treatment through 12 months (every 9 weeks)

Awards & highlights

Study Summary

This trial will test a novel drug's safety & effectiveness when used alone or with other treatments to fight cancer.

Who is the study for?

This trial is for adults with advanced or metastatic tumors that are EGFR positive and have worsened despite treatment. They must have tried at least one therapy, be in good overall health with proper organ function, and not be on recent cancer treatments. Participants need measurable disease, an ECOG performance status of 0-1, a life expectancy over three months, and agree to use contraception.Check my eligibility

What is being tested?

The study tests DK210(EGFR), alone or with other therapies like immunotherapy, chemotherapy or radiation. It aims to assess safety and how the body responds to the drug by looking at certain biomarkers in patients with various types of solid tumors.See study design

What are the potential side effects?

Potential side effects may include typical reactions associated with immune checkpoint blockers (like fatigue or skin reactions), chemotherapy (such as nausea or hair loss), radiation therapy (skin redness or irritation) and any specific effects related to DK210(EGFR).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is worsening, shown by symptoms, tumor growth, or imaging.

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I have tried at least one cancer treatment without success and haven't had any cancer treatment or surgery in the last 4 weeks.

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I have at least one tumor that can be measured on a scan.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initiation of treatment through 12 months (every 9 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from initiation of treatment through 12 months (every 9 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of treatment through 12 months (every 9 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Identify recommended dose of DK210 (EGFR)

Incidence of Adverse Events (AE) of DK210 (EGFR) in combination with radiation, chemotherapy, or checkpoint blockers in Parts B, C, D

Incidence of Adverse Events (AEs) with DK210 (EGFR)

Secondary outcome measures

Best response rate at 9 weeks

Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points

Overall Survival (OS)

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: DK210 (EGFR) Monotherapy (Dose escalation and expansion)Experimental Treatment1 Intervention

DK210 (EGFR) will be administered as monotherapy three times per week via subcutaneous (SC) administration. Dose will be escalated from 0.025 mg/kg to 0.3 mg/kg or until unacceptable toxicity, disease progression, or withdrawal of consent. An expansion cohort at the optimal dose will be enrolled in parallel with the combination arms.

Group II: DK210 (EGFR) + radiationExperimental Treatment2 Interventions

In patients with need of palliative radiation, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with short course radiation therapy (10 fractions or less) until unacceptable toxicity, disease progression, or withdrawal of consent

Group III: DK210 (EGFR) + immunotherapyExperimental Treatment2 Interventions

In patients with good tolerance of first line immunotherapy, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with intravenous (IV) immune checkpoint blockers until unacceptable toxicity, disease progression, or withdrawal of consent

Group IV: DK210 (EGFR) + chemotherapyExperimental Treatment2 Interventions

In patients with good tolerance of first line systemic therapy, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with second-line intravenous (IV) chemotherapy until unacceptable toxicity, disease progression, or withdrawal of consent

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation therapy

2013

Completed Phase 3

~2850

Chemotherapy

2003

Completed Phase 4

~3050

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

DEKA BiosciencesLead Sponsor

Charlotte Moser, MD, PhD, MBAStudy DirectorDEKA Biosciences

Medical OfficerStudy DirectorDEKA Biosciences

2 Previous Clinical Trials

305 Total Patients Enrolled

Media Library

DK210 (EGFR) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05704985 — Phase 1

Pancreatic Cancer Research Study Groups: DK210 (EGFR) Monotherapy (Dose escalation and expansion), DK210 (EGFR) + radiation, DK210 (EGFR) + immunotherapy, DK210 (EGFR) + chemotherapy

Pancreatic Cancer Clinical Trial 2023: DK210 (EGFR) Highlights & Side Effects. Trial Name: NCT05704985 — Phase 1

DK210 (EGFR) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05704985 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned DK210 (EGFR) Monotherapy (Dose escalation and expansion)?

"As this is an early phase clinical trial, our team at Power gave DK210 (EGFR) Monotherapy (Dose escalation and expansion) a score of 1 due to the limited data available on its efficacy and security."

Answered by AI

Are there any openings for participation in this experiment at the moment?

"According to clinicaltrials.gov, this clinical trial is open for recruitment and has recently been updated on February 22nd 2023 after being initially posted on the 1st of February 2023."

Answered by AI

What is the current population of participants receiving treatment in this trial?

"Affirmative. Clinicaltrials.gov reveals that this trial, which was initially advertised on February 1st 2023, is actively recruiting candidates. Sixty participants must be enrolled from one medical center to complete the study's objectives."

Answered by AI

What is the main aim of this clinical experiment?

"DEKA Biosciences, the clinical trial's main sponsor, has specified that efficacy and safety data will be gathered over a 90-day period. This includes measures such as identifying an optimal dosage of DK210 (EGFR), assessing response rate at 9 weeks based on physical examination results and imaging scans, calculating progression-free survival time from initiation to disease recurrence or mortality, and overall survival spanning from first administration until death."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors

2023. "Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05704985.

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