Clinical trial • Phase II • Oncology

ac-ala-gly-ser-cys(1)-tyr-cys(2)-ser-gly-pro-pro-arg-phe-glu-cys(2)-trp-cys(1)-tyr-glu-thr-glu-gly-thr-gly-gly-gly-lys(unk)-nh2 conjugated to cy5 dye for Penile squamous cell carcinoma | Tongue squamous cell carcinoma

Phase II trial of ac-ala-gly-ser-cys(1)-tyr-cys(2)-ser-gly-pro-pro-arg-phe-glu-cys(2)-trp-cys(1)-tyr-glu-thr-glu-gly-thr-gly-gly-gly-lys(unk)-nh2 conjugat…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Penile squamous cell carcinoma | Tongue squamous cell carcinoma
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
22-10-2024
First CTIS Authorization Date
12-11-2024

Trial design

None/Not specified-controlled Phase II trial across 1 site in Netherlands.

Comparator
None/Not specified
Target Sample Size
20
Trial Duration For Participant
1

Eligibility

Recruits 20 No vulnerable populations selected; participants must be adults (Age ≥ 18 years). Written informed consent required from the participant prior to any protocol-related procedures; no assent process for minors is described..

Pregnancy Exclusion
Pregnant woman
Vulnerable Population
No vulnerable populations selected; participants must be adults (Age ≥ 18 years). Written informed consent required from the participant prior to any protocol-related procedures; no assent process for minors is described.

Inclusion criteria

  • {"criterion_text":"- Written informed consent, prior to performing any protocol related procedures.\n- Age ≥ 18 years at time of study entry.\n- ≥ T1 penile or tongue squamous cell cancer\n- Scheduled for surgical primary tumour resection"}

Exclusion criteria

  • {"criterion_text":"- Involvement in the planning and/or conduct of the study.\n- Pregnant woman\n- Abstaining from usage of two forms of barrier contraceptive or actively planning pregnancy within 90 days.\n- Severe kidney insufficiency"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The feasibility of intraoperative tumour visualization by means of c-MET targeted fluores-cence imaging will be evaluated, and the imaging result will be correlated to the level of c-MET expression determined using standard immunohistochemistry.","definition_or_measurement_approach":"Imaging result will be correlated to the level of c-MET expression determined using standard immunohistochemistry."}

Secondary endpoints

  • {"endpoint_text":"- Detection and visualization of lymph node metastases in penile and tongue tumour patients.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Identification of dysplasia or carcinoma in situ in penile and tongue tumours.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
20
Recruitment Window Months
87
Consent Approach
Written informed consent from the participant is required prior to performing any protocol-related procedures. Separate subject information and informed consent forms are available for penis and tongue subjects (documents listed), participants are adults (≥18 years). No assent procedures or languages of the consent documents are specified in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
20

Netherlands

Earliest CTIS Part Ii Submission Date
07-11-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
5
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
ENT
Principal Investigator Name
M. Baris Karakullukcu
Principal Investigator Email
b.karakullukcu@nki.nl
Contact Person Name
M. Baris Karakullukcu
Contact Person Email
b.karakullukcu@nki.nl
Number Of Participants
20

Sponsor

Primary sponsor

Full Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
EMI-137
Active Substance
ac-ala-gly-ser-cys(1)-tyr-cys(2)-ser-gly-pro-pro-arg-phe-glu-cys(2)-trp-cys(1)-tyr-glu-thr-glu-gly-thr-gly-gly-gly-lys(unk)-nh2 conjugated to cy5 dye
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
Intravenous bolus injection / IV infusion
Dose Levels
Single dose up to 0.13 mg/kg (max total dose 0.13 mg/kg)
Frequency
Single administration
Maximum Dose
0.13 mg/kg

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