A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC

  • STATUS
    Recruiting
  • End date
    Dec 19, 2023
  • participants needed
    100
  • sponsor
    Sirnaomics
Updated on 19 June 2022

Summary

The purpose of this trial is to evaluate safety, tolerability and efficacy of various doses of STP705 administered as intralesional injection in subjects with cutaneous squamous cell carcinoma (in situ) skin cancer (isSCC).

Description

This is a two-part, double-blind, randomized, placebo-controlled study designed to evaluate safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with isSCC.

A total of up to 100 eligible subjects will be enrolled. Enrolled subjects will be randomly allocated to receive STP705 or placebo injection once weekly for 6 weeks.

After 6 weeks, the lesion will be excised.

In part 1 (dose ranging study): 40 subjects will be randomized to receive 1 of the 3 STP705 doses or placebo.

An interim analysis will be done after all subjects have completed end of treatment (EOT) visits to determine 2 selected dose levels of STP705 to be used in part of the study.

In part 2: 60 additional subjects will be randomized to receive 1 of the 2 selected doses (from part 1) or placebo.

In both parts at the End of Treatment (EOT), the lesion will be excised.

Details
Condition Squamous Cell Carcinoma in Situ
Treatment placebo saline, STP705
Clinical Study IdentifierNCT04844983
SponsorSirnaomics
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female adult ≥ 18 years of age
Primary, histologically confirmed trunk or extremity (non- anogenital/-facial/-scalp) isSCC lesion suitable for excision with a minimum diameter of 0.5 cm and with a maximum diameter of 2.0 cm
Histological diagnosis made no more than 6 months prior to the screening visit
No other dermatological disease in the isSCC target site or surrounding area, which in the opinion of the investigator, could interfere with the study
Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period
Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study
Laboratory values for the tests (listed in the Study Schedule) within the reference ranges as defined by the central laboratory, or "out of range" test results that are clinically acceptable to the investigator
Ability to follow study instructions and likely to complete all study requirements
Written informed consent obtained, including consent for tissue to be examined and stored by the Central Histology Lab
Written consent to allow photographs of the target isSCC lesion to be used as part of the study data and documentation
For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral / implant/ injectable/ transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy)

Exclusion Criteria

Pregnant, lactating, or planning to become pregnant
Presence of known or suspected systemic cancer
Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic or micronodular growth patterns in the biopsy specimen
History of recurrence of the target isSCC lesion
Concurrent disease or treatment that suppresses the immune system
Patients with baseline QTC > 480 msec using Frederica's formula
Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk
Known sensitivity to any of the ingredients in the study medication including an allergy to trehalose
Use of a tanning bed or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the study
Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit
Use of systemic retinoids within the 6 months prior to the screening period
Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period
Use of topical immunomodulators within 2 cm of the target isSCC lesion within the 4 weeks prior to the screening period
Treatment with the following topical agents within 2 cm of the target isSCC lesion within the 4 weeks prior to the screening visit: aminolevulinic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, ingenol mebutate, or imiquimod
Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target isSCC lesion during the 4 weeks prior to the screening visit
Evidence of current chronic alcohol or drug abuse
Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit
In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note