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DK210 (EGFR) Monotherapy (Dose escalation and expansion) for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NEXT Oncology, Fairfax, VACancer+8 MoreDK210 (EGFR) - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions
  • Cancer
  • Solid Tumors
  • Colorectal Cancer
  • Pancreatic Cancer
  • Non-Small Cell Lung Cancer
  • Head and Neck Cancer
  • Gynecologic Cancers
  • Skin Cancer
  • Kidney Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 8 Secondary · Reporting Duration: From initiation of treatment through 12 months (every 9 weeks)

Month 24
Overall Survival (OS)
Month 12
Serum concentrations of DK210 (EGFR) will be determined at various time points
Serum concentrations of proinflammatory cytokines such as IL-6, IL-10, TNFa, IL-1b, and interferon (IFN)-g will be assessed at various time points
Serum will be assayed for the presence of anti-DK210 (EGFR) antibodies
Day 63
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Day 63
Best response rate at 9 weeks
Month 12
Overall response rate (ORR)
Day 90
Identify recommended dose of DK210 (EGFR)
Day 90
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)
Month 24
Progression-free (PFS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Pembrolizumab
1
Dose Escalation (Phase 1)
1
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Trial Design

4 Treatment Groups

DK210 (EGFR) Monotherapy (Dose escalation and expansion)
1 of 4
DK210 (EGFR) + chemotherapy
1 of 4
DK210 (EGFR) + radiation
1 of 4
DK210 (EGFR) + immunotherapy
1 of 4

Experimental Treatment

60 Total Participants · 4 Treatment Groups

Primary Treatment: DK210 (EGFR) Monotherapy (Dose escalation and expansion) · No Placebo Group · Phase 1

DK210 (EGFR) Monotherapy (Dose escalation and expansion)
Biological
Experimental Group · 1 Intervention: DK210 (EGFR) · Intervention Types: Biological
DK210 (EGFR) + chemotherapyExperimental Group · 2 Interventions: DK210 (EGFR), Chemotherapy · Intervention Types: Biological, Drug
DK210 (EGFR) + radiationExperimental Group · 2 Interventions: DK210 (EGFR), Radiation therapy · Intervention Types: Biological, Radiation
DK210 (EGFR) + immunotherapyExperimental Group · 2 Interventions: DK210 (EGFR), Immune checkpoint blockers · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2840
Chemotherapy
2003
Completed Phase 4
~2740

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from initiation of treatment through 12 months (every 9 weeks)

Who is running the clinical trial?

DEKA BiosciencesLead Sponsor
Charlotte Moser, MD, PhD, MBAStudy DirectorDEKA Biosciences

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received multiple treatments for your cancer, but have not had surgery or taken any new medications for at least 4 weeks.
There may be further requirements that you need to meet.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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