Squamous Cell Carcinoma in SituPhase 2NCT04844983
A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC
A Phase 2 study testing STP705 in people with Squamous Cell Carcinoma in Situ, run by Sirnaomics at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma in Situ
- What is being tested?
- STP705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 May 2021to 6 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37909
Tennessee Clinical Research
Nashville, Tennessee, 37215
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Investigate MD
Scottsdale, Arizona, 85255
Research Institute of the Southeast LLC
West Palm Beach, Florida, 33401
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
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).
Read the detailed 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.
- Conditions
- Squamous Cell Carcinoma in Situ
- Being tested
- STP705, Placebo Saline
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP705Drug
Also called STP705 Powder for Injection
The STP705 drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively.
Placebo SalineOther
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Arm A | Experimental | STP705 30 μg dose, intralesional injection, given once a week for 6 weeks. Receives: Drug: STP705 |
| Part 1: Arm B | Experimental | STP705 60 μg dose, intralesional injection, given once a week for 6 weeks. Receives: Drug: STP705 |
| Part 1: Arm C | Experimental | STP705 90 μg dose, intralesional injection, given once a week for 6 weeks. Receives: Drug: STP705 |
| Part 1: Arm D | Other | Placebo (normal saline), intralesional injection, given once a week for 6 weeks. Receives: Other: Placebo Saline |
| Part 2: Arm A, B or C | Experimental | STP705 selected dose 1, intralesional injection, given once a week for 6 weeks. Receives: Drug: STP705 |
| Part 2: Arm A or B or C | Experimental | STP705 selected dose 2, intralesional injection, given once a week for 6 weeks. Receives: Drug: STP705 |
| Part 2: Arm D | Other | Placebo (normal saline), intralesional injection, given once a week for 6 weeks. Receives: Other: Placebo Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with histological clearance of treated isSCC lesion
Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).
Measured: 6 weeks
Secondary outcomes (1)
Change in size of the treated isSCC lesion
Change in size of the treated isSCC lesion over the 6-week treatment period.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start18 May 2021
- Primary completion24 Aug 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma in SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: 40 subjects randomized in a 1:1:1:1 ratio to receive 6 weeks of treatment of placebo, 30 ug, 60 ug, or 90 ug of STP705. Enrollment will be temporarily stopped after the 40th subject. Interim Analysis will be done for dose response assessment and selection of the 2 doses for Part 2 of the study. Part 2: 60 additional subjects will be randomized in a 1:1:1 ratio to receive placebo or one of the 2 selected STP705 doses.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirnaomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Nestor, MD, Principal investigator, Center for Clinical and Cosmetic ResearchDavid Goldberg, Principal investigator, Schweiger Dermatology GroupMichael Gold, MD, Principal investigator, Tennessee Clinical ResearchEdward Lain, MD, Principal investigator, Austin Institute for Clinical ResearchKenneth Beer, MD, Principal investigator, Research Institute of the Southeast LLCBrenda LaTowsky, MD, Principal investigator, Investigate MDEdward Primka, MD, Principal investigator, Dermatology Associates of KnoxvilleGirish Munavalli, MD, Principal investigator, Dermatology, Laser and Vein Specialists of the Carolinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844983
- Sponsor's protocol ID
- SRN-705-008
- Status last verified
- Mar 2024
- First submitted
- 9 Apr 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
- ClinicalTrials.gov ID
- NCT04844983
- Acronym / sponsor ID
- SRN-705-008
- Conditions
- Squamous Cell Carcinoma in Situ
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- SirnaomicsIndustry (pharma, biotech, devices)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Part 1: 40 subjects randomized in a 1:1:1:1 ratio to receive 6 weeks of treatment of placebo, 30 ug, 60 ug, or 90 ug of STP705. Enrollment will be temporarily stopped after the 40th subject. Interim Analysis will be done for dose response assessment and selection of the 2 doses for Part 2 of the study. Part 2: 60 additional subjects will be randomized in a 1:1:1 ratio to receive placebo or one of the 2 selected STP705 doses.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Arm A | Experimental | Drug: STP705STP705 30 μg dose, intralesional injection, given once a week for 6 weeks. |
| Part 1: Arm B | Experimental | Drug: STP705STP705 60 μg dose, intralesional injection, given once a week for 6 weeks. |
| Part 1: Arm C | Experimental | Drug: STP705STP705 90 μg dose, intralesional injection, given once a week for 6 weeks. |
| Part 1: Arm D | Other | Other: Placebo SalinePlacebo (normal saline), intralesional injection, given once a week for 6 weeks. |
| Part 2: Arm A, B or C | Experimental | Drug: STP705STP705 selected dose 1, intralesional injection, given once a week for 6 weeks. |
| Part 2: Arm A or B or C | Experimental | Drug: STP705STP705 selected dose 2, intralesional injection, given once a week for 6 weeks. |
| Part 2: Arm D | Other | Other: Placebo SalinePlacebo (normal saline), intralesional injection, given once a week for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STP705Also: STP705 Powder for InjectionThe STP705 drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively. | Drug | Part 1: Arm A, Part 1: Arm B, Part 1: Arm C, Part 2: Arm A or B or C, Part 2: Arm A, B or C |
| Placebo SalineNormal Saline | Other | Part 1: Arm D, Part 2: Arm D |
Primary outcome
Proportion of participants with histological clearance of treated isSCC lesion
Time frame: 6 weeks
Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).
1 secondary outcome
Change in size of the treated isSCC lesion
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Nestor, MD principal investigator
Center for Clinical and Cosmetic Research
David Goldberg principal investigator
Schweiger Dermatology Group
Michael Gold, MD principal investigator
Tennessee Clinical Research
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STP705 in people with Squamous Cell Carcinoma in Situ, run by Sirnaomics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with histological clearance of treated isSCC lesion (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.