Facial isSCCPhase 1/2isSCCNCT05421013
Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Adults With Facial isSCC
A Phase 1/2 study testing STP705 in people with Facial isSCC, run by Sirnaomics at 1 site in United States.
Trial summary
Open label, dose escalation to evaluate safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial isSCC
- What is being tested?
- STP705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 29 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Inclusion Criteria: Subjects are required to meet all of the following criteria for enrollment into the study:
- Male or female adult ≥ 18 years of age.
- Primary, histologically confirmed facial isSCC lesion suitable for excision with a minimum diameter of 0.5 cm and with a maximum diameter of 2.0 cm.
- Histological diagnosis of a qualified isSCC skin lesion (evidenced by a confirmatory histopathology report) made no more than 6 months prior to the screening visit.
- No other dermatological disease in the isSCC target lesion 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 lesion and surrounding area during the treatment period (sunscreen and moisturizers allowed).
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- 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 local 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 female subjects of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral / implantable / injectable / transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy at least 6 months prior to screening).
Who cannot join
- Pregnant, lactating, or planning to become pregnant.
- Presence of known or suspected systemic cancer.
- Confirmatory histological report of the qualified isSCC lesion reveals evidence of severe squamous metaplasia, infiltrative, desmoplastic or micronodular growth patterns in the opinion of the investigator.
- History of recurrence of the target isSCC lesion.
- Concurrent disease or treatment that suppresses the immune system.
- Subjects with baseline QT corrected interval QTc > 480 msec using Fridericia'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, tirbanibulin, 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 that, in the opinion of the investigator, would impair the subject's ability to comply with study schedule.
- 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
1 site in 1 country.
United States1 site
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
Official title: An Open Label, Dose Escalation Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Subjects With Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
Open label, dose escalation to evaluate safety.
Read the detailed description
Evaluate safety, tolerability, and efficacy of various doses of STP705 administered as intralesional injection in subjects with facial isSCC.
There will be 3 cohorts of 10 subjects each. Enrolled subjects will receive STP705 once weekly for 6 weeks. The lesion will be excised 60 days after.
- Conditions
- Facial isSCC
- Being tested
- STP705
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
STP705 targets TGFB-1 and COX-2 mRNA respectively.
| Study group | Role | What they receive |
|---|---|---|
| STP705 30ug | Experimental | STP705 will be administered once weekly for 6 weeks Receives: Drug: STP705 |
| STP705 60ug | Experimental | STP705 will be administered once weekly for 6 weeks Receives: Drug: STP705 |
| STP705 90ug | Experimental | STP705 will be administered once weekly for 6 weeks Receives: Drug: STP705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Histological Clerance of Treated isSCC Lesion at the End of Treatment
Histological clearance will be defined as the absence of detectable evidence of isSCC tumor cell nests determined by pathology review
Measured: 21 weeks
Secondary outcomes (1)
Change in Size of the Treated isSCC Lesion Over the Pre-excision Treatment Period.
A Baseline assessment of lesion size was made by the investigator at T1 (first treatment visit). This was measured by widest width and longest length using a caliper or a ruler as deemed by the investigator's judgement. The change in size was assessed every visit until the surgical excision of isSCC at the EOT Visit.
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Aug 2022
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Why it stopped: The Sponsor terminated the study at the conclusion of Cohort A. Cohort B and Cohort C were not initiated. The Sponsor terminated the study before reaching the planned 30 subjects for corporate strategic reasons not related to safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Facial isSCCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3 cohorts. In the absence of DLT, subsequent cohorts will receive increasing dose of STP705
- Masking
- None (open label)
- Enrolment
- 9 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 Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421013
- Sponsor's protocol ID
- SRN-705-011
- Acronym
- isSCC
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2022
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose Escalation Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Subjects With Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
- ClinicalTrials.gov ID
- NCT05421013
- Acronym / sponsor ID
- isSCC / SRN-705-011
- Conditions
- Facial isSCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor terminated the study at the conclusion of Cohort A. Cohort B and Cohort C were not initiated. The Sponsor terminated the study before reaching the planned 30 subjects for corporate strategic reasons not related to safety.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- SirnaomicsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Posted 7 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label, dose escalation to evaluate safety.
Detailed description
Evaluate safety, tolerability, and efficacy of various doses of STP705 administered as intralesional injection in subjects with facial isSCC.
There will be 3 cohorts of 10 subjects each. Enrolled subjects will receive STP705 once weekly for 6 weeks. The lesion will be excised 60 days after.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 cohorts. In the absence of DLT, subsequent cohorts will receive increasing dose of STP705
| Arm | Type | Receives |
|---|---|---|
| STP705 30ug | Experimental | Drug: STP705STP705 will be administered once weekly for 6 weeks |
| STP705 60ug | Experimental | Drug: STP705STP705 will be administered once weekly for 6 weeks |
| STP705 90ug | Experimental | Drug: STP705STP705 will be administered once weekly 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 (12 listed)
- Inclusion Criteria: Subjects are required to meet all of the following criteria for enrollment into the study:
- Male or female adult ≥ 18 years of age.
- Primary, histologically confirmed facial isSCC lesion suitable for excision with a minimum diameter of 0.5 cm and with a maximum diameter of 2.0 cm.
- Histological diagnosis of a qualified isSCC skin lesion (evidenced by a confirmatory histopathology report) made no more than 6 months prior to the screening visit.
- No other dermatological disease in the isSCC target lesion or surrounding area, which in the opinion of the investigator, could interfere with the study.
Key exclusion criteria (18 listed)
- Pregnant, lactating, or planning to become pregnant.
- Presence of known or suspected systemic cancer.
- Confirmatory histological report of the qualified isSCC lesion reveals evidence of severe squamous metaplasia, infiltrative, desmoplastic or micronodular growth patterns in the opinion of the investigator.
- 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 InjectionSTP705 targets TGFB-1 and COX-2 mRNA respectively. | Drug | STP705 30ug, STP705 60ug, STP705 90ug |
Primary outcome
Proportion of Participants With Histological Clerance of Treated isSCC Lesion at the End of Treatment
Time frame: 21 weeks
Histological clearance will be defined as the absence of detectable evidence of isSCC tumor cell nests determined by pathology review
1 secondary outcome
Change in Size of the Treated isSCC Lesion Over the Pre-excision Treatment Period.
Time frame: 21 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STP705 in people with Facial isSCC, run by Sirnaomics at 1 site 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 12 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: stopped early, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 7 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Clerance of Treated isSCC Lesion at the End of Treatment (time frame: 21 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 7 Oct 2026.