Superficial Basal Cell CarcinomaPhase 1NMSCNCT04470726
Safety and Efficacy Evaluation of AIV001 in Nonmelanoma Skin Cancer of the Low Risk Basal Cell Carcinoma Subtype
A Phase 1 study testing AIV001 and AIV001 suspension in people with Superficial Basal Cell Carcinoma and Nodular Basal Cell Carcinoma, run by AiViva BioPharma, Inc. at 4 sites in United States.
Trial summary
To evaluate safety and efficacy of AIV001 treatment on low-risk Nonmelanoma Skin Caner of the basal cell carcinoma subtype. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma, Nonmelanoma Skin Cancers
- What is being tested?
- AIV001 and AIV001 suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Aug 2020to 28 Jul 2023
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 80 years, inclusive
- No clinically relevant abnormalities identified by a detailed medical history and vital signs
- Presence of a histologically confirmed low risk BCC lesion, with well-defined borders, and with a largest diameter measure before biopsy of 5 mm to 20 mm, located on arms or trunk
- Histological diagnosis of the target lesion must have been conducted 5 to 30 days prior to Day 1
- No other dermatological disease within 50 mm of the target lesion at Day 1
- No prior or concurrent treatment of the target lesion (including radiation therapy)
- Willing to undergo surgical excision approximately 63 days after first treatment.
Who cannot join
- History or presence of systemic cancer
- Prior radiation treatment at the lesion site or anywhere else on the body within the past 20 years
- Concurrent disease or treatment that suppresses the immune system (eg, previous organ transplant history, etc.)
- Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other major systemic disease that could complicate execution of the protocol or interpretation of the study results.
- History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula
- History of recurrence or presence of any other tumor subtype in the target lesion
Show all 9Show fewer
- Concurrent presence of a malignant lesion within 100 mm of the target lesion that will require treatment during the study
- Current enrollment in any other investigational drug or device study within 60 days of Day 1 of this study
- Evidence of dermatological disease or confounding dermatological condition that would hinder carrying out the study or interpreting the results (eg, atopic dermatitis, eczema, psoriasis, xeroderma pigmentosa, etc.)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Island Dermatology
Newport Beach, California, 92660
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Skin Surgery Medical Group
San Diego, California, 92117
About this study
Official title: An Exploratory Study to Evaluate the Safety and Efficacy of AIV001 Intradermally Administered in Subjects With Biopsy-confirmed Basal Cell Carcinoma
To evaluate safety and efficacy of AIV001 treatment on low-risk Nonmelanoma Skin Caner of the basal cell carcinoma subtype.
Read the detailed description
AIV001 (axitinib) has been formulated to provide focal disease-modifying therapy for patients with nonmelanoma skin cancer (NMSC) of the basal cell carcinoma (BCC) subtype. AIV001 targets angiogenesis, inflammation, and fibrosis associated with various pathological skin conditions and was formulated as a simple intradermal/intratumoral injection demonstrating prolonged skin residence. Surgical excision is the standard treatment for NMSC of the basal cell carcinoma subtype for lesions of < 20 mm. Surgical removal of lesions is effective but for some patients unwilling or contraindicated for surgery a nonsurgical option is needed. A nonsurgical option will eliminate post-surgical complications and scarring experienced after lesion removal. Also, specific anatomical location of lesions present cosmesis (i.e., face) or healing challenges (i.e., lower limbs). An effective injectable will benefit patients who are averse to surgery, at risk of wound healing complications or concerned with cosmesis outcomes or fatigued from multiple surgeries. Patient populations (i.e., elderly or patients with diabetes) who are at risk of delayed wound healing would benefit from an injectable option. This study will evaluate injection methods, interval of treatment, four ascending doses, safety, histological clearance and clinical clearance of biopsy-confirmed "low-risk" BCC lesion of <20 mm located on non-facial skin.
- Being tested
- AIV001, AIV001 suspension
- Keywords
- Nonmelanoma Skin Cancer, Keratinocyte Carcinoma, NMSC, BCC, 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.
AIV001Drug
Intradermal/intratumoral
AIV001 suspensionDrug
AIV001 is administered as a aqueous suspension by an intradermal/intratumoral injection
| Study group | Role | What they receive |
|---|---|---|
| AIV001 Treatment Dose 1 | Experimental | Intradermal/intratumoral, Dose 1 Receives: Drug: AIV001; Drug: AIV001 suspension |
| AIV001 Treatment Dose 2 | Experimental | Intradermal/intratumoral, Dose 2 Receives: Drug: AIV001; Drug: AIV001 suspension |
| AIV001 Treatment Dose 3 | Experimental | Intradermal/intratumoral, Dose 3 Receives: Drug: AIV001; Drug: AIV001 suspension |
| AIV001 Treatment Dose 4 | Experimental | Intradermal/intratumoral, Dose 4 Receives: Drug: AIV001; Drug: AIV001 suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events during study period
Incidence of adverse events
Measured: Approximately 119 days
Percentage of Histological Clearance achieved of BCC treated lesion
full clearance is no residual BCC cells by histology
Measured: Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
Secondary outcomes (1)
Percentage of Clinical Clearance of treated basal cell carcinoma lesion on skin surface
Number of participants with no surface tumor visible in the study lesion on excision day
Measured: Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start18 Aug 2020
- Primary completion20 Jun 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects will be treated once, twice or three times at 21 days interval and lesions examined at the end of the study investigators will evaluate the lesion surface area for clearance and excise the original lesion area for histological assessment.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiViva BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470726
- Sponsor's protocol ID
- AIV001-C01
- Acronym
- NMSC
- Status last verified
- Nov 2026
- First submitted
- 10 Jul 2020
- Last updated
- 4 Nov 2026
- Results posted
- No
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Safety and Efficacy of AIV001 Intradermally Administered in Subjects With Biopsy-confirmed Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04470726
- Acronym / sponsor ID
- NMSC / AIV001-C01
- Keywords
- Nonmelanoma Skin Cancer, Keratinocyte Carcinoma, NMSC, BCC, basal cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AiViva BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 14 Jul 2020 (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.
To evaluate safety and efficacy of AIV001 treatment on low-risk Nonmelanoma Skin Caner of the basal cell carcinoma subtype.
Detailed description
AIV001 (axitinib) has been formulated to provide focal disease-modifying therapy for patients with nonmelanoma skin cancer (NMSC) of the basal cell carcinoma (BCC) subtype. AIV001 targets angiogenesis, inflammation, and fibrosis associated with various pathological skin conditions and was formulated as a simple intradermal/intratumoral injection demonstrating prolonged skin residence. Surgical excision is the standard treatment for NMSC of the basal cell carcinoma subtype for lesions of < 20 mm. Surgical removal of lesions is effective but for some patients unwilling or contraindicated for surgery a nonsurgical option is needed. A nonsurgical option will eliminate post-surgical complications and scarring experienced after lesion removal. Also, specific anatomical location of lesions present cosmesis (i.e., face) or healing challenges (i.e., lower limbs). An effective injectable will benefit patients who are averse to surgery, at risk of wound healing complications or concerned with cosmesis outcomes or fatigued from multiple surgeries. Patient populations (i.e., elderly or patients with diabetes) who are at risk of delayed wound healing would benefit from an injectable option. This study will evaluate injection methods, interval of treatment, four ascending doses, safety, histological clearance and clinical clearance of biopsy-confirmed "low-risk" BCC lesion of <20 mm located on non-facial skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will be treated once, twice or three times at 21 days interval and lesions examined at the end of the study investigators will evaluate the lesion surface area for clearance and excise the original lesion area for histological assessment.
| Arm | Type | Receives |
|---|---|---|
| AIV001 Treatment Dose 1 | Experimental | Drug: AIV001, Drug: AIV001 suspensionIntradermal/intratumoral, Dose 1 |
| AIV001 Treatment Dose 2 | Experimental | Drug: AIV001, Drug: AIV001 suspensionIntradermal/intratumoral, Dose 2 |
| AIV001 Treatment Dose 3 | Experimental | Drug: AIV001, Drug: AIV001 suspensionIntradermal/intratumoral, Dose 3 |
| AIV001 Treatment Dose 4 | Experimental | Drug: AIV001, Drug: AIV001 suspensionIntradermal/intratumoral, Dose 4 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 18 to 80 years, inclusive
- No clinically relevant abnormalities identified by a detailed medical history and vital signs
- Presence of a histologically confirmed low risk BCC lesion, with well-defined borders, and with a largest diameter measure before biopsy of 5 mm to 20 mm, located on arms or trunk
- Histological diagnosis of the target lesion must have been conducted 5 to 30 days prior to Day 1
- No other dermatological disease within 50 mm of the target lesion at Day 1
Key exclusion criteria (9 listed)
- History or presence of systemic cancer
- Prior radiation treatment at the lesion site or anywhere else on the body within the past 20 years
- Concurrent disease or treatment that suppresses the immune system (eg, previous organ transplant history, etc.)
- Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other major systemic disease that could complicate execution of the protocol or interpretation of the study results.
- History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula
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 |
|---|---|---|
| AIV001Intradermal/intratumoral | Drug | AIV001 Treatment Dose 1, AIV001 Treatment Dose 2, AIV001 Treatment Dose 3, AIV001 Treatment Dose 4 |
| AIV001 suspensionAIV001 is administered as a aqueous suspension by an intradermal/intratumoral injection | Drug | AIV001 Treatment Dose 1, AIV001 Treatment Dose 2, AIV001 Treatment Dose 3, AIV001 Treatment Dose 4 |
Primary outcome
Number of adverse events during study period
Time frame: Approximately 119 days
Incidence of adverse events
Percentage of Histological Clearance achieved of BCC treated lesion
Time frame: Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
full clearance is no residual BCC cells by histology
1 secondary outcome
Percentage of Clinical Clearance of treated basal cell carcinoma lesion on skin surface
Time frame: Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
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 4 Nov 2026.
Related trials for Superficial Basal Cell Carcinoma
Recruiting
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Skin Cancer, Mucosal Neoplasm of Oral Cavity
Recruiting
Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors
Skin Cancer, Cutaneous Tumor
Active, not recruiting
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)
Skin Cancer, Mucosal Neoplasm of Oral Cavity
Not yet recruiting
High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease in Adults
Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
Active, not recruitingPhase 3
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
Superficial Basal Cell Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AIV001 and AIV001 suspension in people with Superficial Basal Cell Carcinoma and Nodular Basal Cell Carcinoma, run by AiViva BioPharma, Inc. at 4 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 7 inclusion and 9 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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.
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?
Number of adverse events during study period (time frame: Approximately 119 days). The study lists 2 primary outcomes in all. 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 4 Nov 2026.