Basal Cell CarcinomaPhase 2NCT04669808
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell Carcinoma
A Phase 2 study testing STP705 in people with Basal Cell Carcinoma, run by Sirnaomics at 1 site in United States.
Trial summary
This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with Basal Cell Carcinoma (BCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2020to 9 Feb 2023
- Phase
- Phase 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
None listed.
Who cannot join
- Pregnant or lactating.
- Presence of known or suspected systemic cancer.
- Histological evidence of SCC, or any other non-BCC tumor in the biopsy specimen.
- Histological evidence of infiltrative or other aggressive histological subtype growth patterns in the biopsy specimen.
- History of recurrence of the target BCC lesion.
- Evidence of dermatological disease or confounding skin condition with in 2 cm margin of the target BCC lesion, e.g., SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa.
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- 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.
- Use of a tanning beds 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 BCC lesion within the 4 weeks prior to the screening period.
- Treatment with the following topical agents within 2 cm of the target BCC lesion within the 4 weeks prior to the screening visit: amino-levulinic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, ingenol mebutate, or imiquimod.
- Treatment with liquid nitrogen, surgical excision (excluding diagnostic incisional biopsy) or curettage within 2 cm of the target BCC 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.
- Taking any other investigational product within 1 month of first dose of STP705.
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 Localized Injection of STP705 in Adult Patients With Basal Cell Carcinoma
This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with Basal Cell Carcinoma (BCC).
Goals:
- To determine the safe and effective recommended dose of STP705 for the treatment of basal cell carcinoma.
- Analysis of biomarkers common to BCC formation pathway including TGF-β1 and COX-2.
Read the detailed description
Basal cell carcinoma occurs most often on areas of the skin that are exposed to the sun, such as head and neck. The most commonly found clinical feature of Basal Cell Carcinoma (BCC) is an elevated tumor with a pearly and translucent margin and telangiectasia. The color may vary widely from nearly normal skin color to erythematous to violaceous and may also be pigmented. BCC may also resemble noncancerous skin conditions such as eczema or psoriasis. The majority of these cancers occur on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation.
The STP705 drug substance (STP705) is composed of two siRNA oligonucleotides, targeting the expression of TGF-β1 and Cox-2 mRNA respectively. Along with the HKP-enhanced delivery system, the combination is expected to downregulate TGF-β1 and COX-2 expression resulting in the inhibition of tumor growth and provide an alternative non-invasive approach for the treatment of BCC.
This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with BCC. This study seeks to establish a safe and effective recommended dose of STP705 for the treatment of BCC. The clinician will evaluate the change in tumor size at each treatment visit. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. Expression of biomarkers common to the BCC formation pathway, including TGF-β1 and COX-2, will be evaluated.
Safety and tolerability will be assessed by the number of incidence of adverse events (AEs) and serious adverse events (SAEs); the incidence of AEs and SAEs leading to discontinuation of trial medication; the incidence and severity of Local Skin Response (LSR); hypopigmentation and hyperpigmentation following treatment; and the tolerability of repeated localized administration of STP705 as assessed by investigator-evaluation of injection site reactions for all patients and within each cohort.
The study plans to enroll approximately 35 adult patients at up to 3 clinical sites in the United States. The 35 patients will be divided equally among 7 cohorts (30, 60, 90, 120, 180, 240, and 320 μg dose level) of 5 patients each.
- Conditions
- Basal Cell Carcinoma
- Being tested
- STP705
- Keywords
- BCC, STP705, Basal Cell Carcinoma
- Medical subject headings
- Carcinoma, Basal Cell
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
Dry powder for intra-and peri-lesional injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: STP705 30 μg dose | Experimental | Cohort A: STP705 30 μg dose, localized injection, given once a week for 6 weeks Receives: Drug: STP705 |
| Cohort B: STP705 60 μg dose | Experimental | Cohort B: STP705 60 μg dose, localized injection, given once a week for 6 weeks Receives: Drug: STP705 |
| Cohort C: STP705 90 μg dose | Experimental | Cohort C: STP705 90 μg dose, localized injection, given once a week for 6 weeks Receives: Drug: STP705 |
| Cohort D: STP705 120 μg dose | Experimental | Cohort D: STP705 120 μg dose, localized injection, given once a week for 6 weeks Receives: Drug: STP705 |
| Cohort E: STP705 180 μg dose | Experimental | Cohort E: STP705 180 μg dose, localized injection, given once a week for 6 weeks Receives: Drug: STP705 |
| Cohort F: STP705 240 μg dose | Experimental | Cohort F: STP705 240 μg dose, localized injection, given once a week for 6 weeks Receives: Drug: STP705 |
| Cohort G: STP705 320 μg dose | Experimental | Cohort G: STP705 320 μg dose, localized injection, given once a week 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 Clearance of Treated Basal Cell Carcinoma Lesion at the End of Treatment (EOT)
Histological clearance (HC) will be defined as the absence of detectable evidence of BCC tumor cell nests as determined by central pathology review.
Measured: 6 weeks
Secondary outcomes (1)
Change in Clinical Diameter of the Treated Basal Cell Carcinoma Lesion Over the 6 Week Treatment Period
A baseline assessment of lesion clinical diameter will be made by investigator at T1 (first visit). The change in size from baseline to the End of Treatment (EOT) visit (Week 6) will be reported.
Measured: End of Treatment (EOT) visit (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start28 Dec 2020
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
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 Basal Cell CarcinomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the BCC lesion. The participants will receive injections of STP705 once a week for 6 weeks. The clinician will evaluate the change in tumor size at each treatment visit. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirnaomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- Mark Nestor, MD, PhD, Principal investigator, Center for Clinical and Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669808
- Sponsor's protocol ID
- SRN-705-006
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2020
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Sep 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 Localized Injection of STP705 in Adult Patients With Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04669808
- Acronym / sponsor ID
- SRN-705-006
- Conditions
- Basal Cell Carcinoma
- Keywords
- BCC, STP705, Basal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SirnaomicsIndustry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 24 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with Basal Cell Carcinoma (BCC).
Goals:
- To determine the safe and effective recommended dose of STP705 for the treatment of basal cell carcinoma.
- Analysis of biomarkers common to BCC formation pathway including TGF-β1 and COX-2.
Detailed description
Basal cell carcinoma occurs most often on areas of the skin that are exposed to the sun, such as head and neck. The most commonly found clinical feature of Basal Cell Carcinoma (BCC) is an elevated tumor with a pearly and translucent margin and telangiectasia. The color may vary widely from nearly normal skin color to erythematous to violaceous and may also be pigmented. BCC may also resemble noncancerous skin conditions such as eczema or psoriasis. The majority of these cancers occur on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation.
The STP705 drug substance (STP705) is composed of two siRNA oligonucleotides, targeting the expression of TGF-β1 and Cox-2 mRNA respectively. Along with the HKP-enhanced delivery system, the combination is expected to downregulate TGF-β1 and COX-2 expression resulting in the inhibition of tumor growth and provide an alternative non-invasive approach for the treatment of BCC.
This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with BCC. This study seeks to establish a safe and effective recommended dose of STP705 for the treatment of BCC. The clinician will evaluate the change in tumor size at each treatment visit. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. Expression of biomarkers common to the BCC formation pathway, including TGF-β1 and COX-2, will be evaluated.
Safety and tolerability will be assessed by the number of incidence of adverse events (AEs) and serious adverse events (SAEs); the incidence of AEs and SAEs leading to discontinuation of trial medication; the incidence and severity of Local Skin Response (LSR); hypopigmentation and hyperpigmentation following treatment; and the tolerability of repeated localized administration of STP705 as assessed by investigator-evaluation of injection site reactions for all patients and within each cohort.
The study plans to enroll approximately 35 adult patients at up to 3 clinical sites in the United States. The 35 patients will be divided equally among 7 cohorts (30, 60, 90, 120, 180, 240, and 320 μg dose level) of 5 patients each.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the BCC lesion. The participants will receive injections of STP705 once a week for 6 weeks. The clinician will evaluate the change in tumor size at each treatment visit. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.
| Arm | Type | Receives |
|---|---|---|
| Cohort A: STP705 30 μg dose | Experimental | Drug: STP705Cohort A: STP705 30 μg dose, localized injection, given once a week for 6 weeks |
| Cohort B: STP705 60 μg dose | Experimental | Drug: STP705Cohort B: STP705 60 μg dose, localized injection, given once a week for 6 weeks |
| Cohort C: STP705 90 μg dose | Experimental | Drug: STP705Cohort C: STP705 90 μg dose, localized injection, given once a week for 6 weeks |
| Cohort D: STP705 120 μg dose | Experimental | Drug: STP705Cohort D: STP705 120 μg dose, localized injection, given once a week for 6 weeks |
| Cohort E: STP705 180 μg dose | Experimental | Drug: STP705Cohort E: STP705 180 μg dose, localized injection, given once a week for 6 weeks |
| Cohort F: STP705 240 μg dose | Experimental | Drug: STP705Cohort F: STP705 240 μg dose, localized injection, given once a week for 6 weeks |
| Cohort G: STP705 320 μg dose | Experimental | Drug: STP705Cohort G: STP705 320 μg dose, localized 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 (0 listed)
Key exclusion criteria (21 listed)
- Pregnant or lactating.
- Presence of known or suspected systemic cancer.
- Histological evidence of SCC, or any other non-BCC tumor in the biopsy specimen.
- Histological evidence of infiltrative or other aggressive histological subtype growth patterns in the biopsy specimen.
- History of recurrence of the target BCC lesion.
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 InjectionDry powder for intra-and peri-lesional injection. | Drug | Cohort A: STP705 30 μg dose, Cohort B: STP705 60 μg dose, Cohort C: STP705 90 μg dose, Cohort D: STP705 120 μg dose, Cohort E: STP705 180 μg dose, Cohort F: STP705 240 μg dose, Cohort G: STP705 320 μg dose |
Primary outcome
Proportion of Participants With Histological Clearance of Treated Basal Cell Carcinoma Lesion at the End of Treatment (EOT)
Time frame: 6 weeks
Histological clearance (HC) will be defined as the absence of detectable evidence of BCC tumor cell nests as determined by central pathology review.
1 secondary outcome
Change in Clinical Diameter of the Treated Basal Cell Carcinoma Lesion Over the 6 Week Treatment Period
Time frame: End of Treatment (EOT) visit (Week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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, PhD 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 2 study testing STP705 in people with Basal Cell Carcinoma, 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 0 inclusion and 21 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 24 Sep 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 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?
Yes. Results are posted in the registry (first posted 24 Sep 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 Clearance of Treated Basal Cell Carcinoma Lesion at the End of Treatment (EOT) (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 24 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.