Can a direct injection clear skin cancer without surgery?

NCT ID NCT04669808

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

32 people

The number who actually took part.

Started

Dec 2020

Finished

Feb 2023

Lead sponsor

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

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

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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