Can a direct injection clear skin cancer without surgery?
NCT ID NCT04669808
First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time
Summary
Researchers are testing an experimental drug called STP705 as a localized injection for adults with basal cell carcinoma, a common type of skin cancer. The trial enrolls 32 adults who have a confirmed tumor on the trunk or limbs that is between 0.5 and 2 centimeters wide and suitable for surgical removal. Participants receive escalating doses of STP705 injected into and around the tumor over six weeks. The main goal is to see whether the injections eliminate detectable tumor cells, with secondary checks on tumor size and biomarkers linked to cancer formation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STP705, an experimental injectable drug given directly into basal cell carcinoma skin tumors
- What this could lead to
- If STP705 clears tumors, it could offer a needle-based alternative to surgery for some basal cell carcinomas, leaving less scarring and avoiding a scalpel.
- What could go wrong
- This is a small, early-phase trial with 32 participants and no control group, so results may not hold up in larger studies. Injections can cause local skin reactions, and not every tumor may respond.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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32 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Feb 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subjects are required to meet all of the following criteria for enrollment into the study: 1. Male or female adult ≥ 18 years of age. 2. Primary, histologically confirmed trunk or extremity (non-peri-orbital/-anogenital/-facial/-scalp) basal cell carcinoma lesion suitable for excision with a minimum diameter of 0.5 cm and with a maximum diameter of 2.0 cm. 3. Histological diagnosis made no more than 6 months prior to the screening visit. 4. Histological biopsy removed ≤25% of the original volume of the target lesion. 5. No other dermatological disease in the BCC target site or surrounding area, which in the opinion of the investigator, could interfere with the study. 6. Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period. 7. 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. 8. 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 is clinically acceptable to the investigator. Ability to follow study instructions and likely to complete all study requirements. 9. Written informed consent obtained, including consent for tissue to be examined and stored by the Central Histology Lab. 10. Written consent to allow photographs of the target BCC lesion to be used as part of the study data and documentation. 11. 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: 1. Pregnant or lactating. 2. Presence of known or suspected systemic cancer. 3. Histological evidence of SCC, or any other non-BCC tumor in the biopsy specimen. 4. Histological evidence of infiltrative or other aggressive histological subtype growth patterns in the biopsy specimen. 5. History of recurrence of the target BCC lesion. 6. 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. 7. Concurrent disease or treatment that suppresses the immune system; 8. Patients with baseline QTC \> 480 msec using Frederica's formula. 9. 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. 10. Known sensitivity to any of the ingredients in the study medication. 11. Use of a tanning beds or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the study. 12. Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit. 13. Use of systemic retinoids within the 6 months prior to the screening period. 14. Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period. 15. Use of topical immunomodulators within 2 cm of the target BCC lesion within the 4 weeks prior to the screening period. 16. 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. 17. 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. 18. Evidence of current chronic alcohol or drug abuse. 19. Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit. 20. In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study. 21. Taking any other investigational product within 1 month of first dose of STP705.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180, United States
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