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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

Must not have

Subjects with documented diffuse peritoneal disease or persistent abundant ascites

Subjects with known prolonged QtC interval

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have widespread disease in my abdomen or persistent fluid buildup.

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My heart's electrical cycle is longer than normal.

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I haven't had major surgery or certain cancer treatments in the last 4 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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