Dose-finding Phase 1 Trial: Evaluating Safety and Biomarkers Using DK210 (EGFR) for Inoperable Locally Advanced and/or Metastatic EGFR+ Tumors With Progressive Disease Failing Systemic Therapy
Dose-finding Phase 1 Trial: Evaluating Safety and Biomarkers Using DK210 (EGFR) for Inoperable Locally Advanced and/or Metastatic EGFR+ Tumors With Progressive Disease Failing Systemic Therapy
NCT #
NCT05704985
Condition(s)
Bladder, Colorectal, head and neck squamous cell carcinoma, Melanoma, Non-Small Cell Lung, Other Squamous Cell Carcinoma, Pancreatic, Renal Cell Carcinoma
Molecular Target(s)
EGFR amplification
Drug Classification(s)
Targeted Cytokine Therapy
Agents(s)
DK210 (EGFR)
Phase(s)
I
Mechanism of Action
DK210 is an EGFR-targeting IL2/IL10
Purpose
- How much of the study agent can be given with an acceptable level of side effects
- The effects of the study agent (good and bad)
- How much of the study agent is absorbed into the blood and how fast it is removed
- How the study agent is acting on your body
- ECOG performance status of 0-1
- Life expectancy of >3 months according to the investigator’s judgment
- Solid tumors known for response on Il-2 or Il-10 and/or high expression of EGFR like all Non-small cell Lung, Skin, Head and Neck, Colon, Kidney, Bladder, Pancreatic cancers and all squamous cell carcinoma of other organs can be included with a classical histology report, specific EGFR expression or amplification reports are needed for other solid tumor types like gynecologic, prostate or triple negative breast cancer
- Measurable disease, defined as at least one (non-irradiated) lesion measurable on CT/MRI or bone scan as defined by RECIST 1.1.
- 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
- Adequate cardiovascular, hematological, liver, and renal function.
- 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.
- Males and females of childbearing potential must agree to use effective contraception starting prior to the first day of treatment and continuing during treatment
- Additional criteria may apply
- Subjects with documented diffuse peritoneal disease or persistent abundant ascites
- Subjects with known prolonged QtC interval
- Concomitant or recent (<4 weeks or 5 half-lives of the last treatment, whichever is shorter) treatment with agents with anti-tumor activity, including immunotherapies, or experimental therapies. Bone treatments and supportive care can be continued
- Major surgery within 4 weeks, Radiation therapy for the treatment of metastases within less than 3 weeks (if single fraction of radiotherapy, then within 2 weeks) and radionuclide therapy for the treatment of metastases within 4 weeks prior to screening
- Uncontrolled intercurrent illness including, but not limited to, ongoing and uncontrolled infection (TBC, COVID or HIV patients treated with at least two anti-retroviral drugs and control of their infection with at least 500 /mm3 CD4+ T-cells in their blood and patients cured from Hepatitis B or C (i.e negativity of PCR) and liver function compatible with eligibility criteria are allowed to participate), multiple myeloma, multiple sclerosis, myasthenia gravis, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirement
- Any other conditions that, in the investigator’s opinion, might indicate the subject to be unsuitable for the study
- Additional criteria may apply
For other adenocarcinomas such as breast, prostate, and gynecological cancer, a histology report stating EGFR expression being high (>50%) or amplification.
Location
MCD
Similar Trials
Discover more trials like this.
Trial Number
Mechanism of Action
Drug Classifications
Target Required
Conditions
Site
UC23-01
Virus-like drug conjugate (VDC) composed of the VLP as thetargeting component and the phthalocyanine dye as the cytotoxic payload
Virus-like drug conjugate
Not Required
Bladder
UCNT
MCLA-128-CL01
Zenocutuzumab, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3
n/a
NRG1 fusion
Non-Small Cell Lung, Pancreatic
MCD
MCLA-129-CL01
MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody
n/a
EGFR, MET
esophageal Squamous Cell Carcinoma, Gastric/GEJ (Gastroesophageal Junction)/Esophageal, head and neck squamous cell carcinoma, Non-Small Cell Lung
MCD
Connect With Us
Whether you want to give a spark of hope or you are looking for it, we are here to help. If you have any questions or concerns, please contact us here.