A Phase 1/2 interventional study of ASN-002 in Basal Cell Carcinoma in Basal Cell Nevus Syndrome, sponsored by Ascend Biopharmaceuticals Ltd. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Ascend Biopharmaceuticals Ltd · Phase 1/2, Interventional, and Treatment
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Among 20 studies in Basal Cell Nevus Syndrome with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Basal Cell Nevus Syndrome · United States.
Among the 20 studies in Basal Cell Nevus Syndrome with a site in United States, this one is the 12th largest by planned enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2017, is the only one in phase 1/2, and was the 14th registered.
35 studies on the registry are indexed under Basal Cell Nevus Syndrome; 4 are open to participants now.
Browse Basal Cell Nevus Syndrome studies →1 of the 20 studies in Basal Cell Nevus Syndrome with a site in United States is open now. Recruiting first, the newest first:
St. Jude Children's Research Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 3 Basal Cell Nevus Syndrome studies recruiting now, 3 set no upper age limit and none stop at 75 or younger; 3 take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 3
First in 2004; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is close to the median of 24 across 25 interventional studies indexed under Basal Cell Nevus Syndrome.
Median enrollment 35 across the 18 interventional studies, 765 across the 2 observational. Of the 18 that completed or were terminated, 12 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 20 have an industry lead sponsor. The 10 most frequent:
Ascend Biopharmaceuticals Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.
Ascend Biopharmaceuticals Ltd has 3 studies filed under Basal Cell Nevus Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Basal Cell Nevus Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The primary objective is to confirm the safety of treating multiple BCCs once weekly x 3 weeks in individuals with Basal Cell Nevus Syndrome (BCNS).
The secondary objectives of the study are to obtain preliminary data on the effectiveness of ASN-002 in the treatment of BCCs in individuals with Basal Cell Nevus Syndrome (BCNS) by
Methodology:
Patients with BCNS who meet the Eligibility Requirements below will be studied. After informed consent is obtained and baseline evaluation, each lesion to be injected will receive ASN-002 once weekly x 3 weeks. Subjects will be premedicated with acetaminophen, 1000mg, 30 minutes prior to injection and continue 650mg, four times/day for two days after injection. Evaluation for toxicity and safety will be performed at 1, 2, 3 and 4 months after the first injection. All target lesions will be excised at 6 months and the subject evaluated for healing one month later.
Subjects with 5 or more lesions will be entered into Cohort A and will receive 1.0 x 1011 vp/injection into each of 4 BCCs, weekly x 3, i.e. weeks 1, 2, and 3, i.e. a total dose of 4.0 x 1011 vp on each day of injections. If one subject in this cohort experiences Grade 3 or greater local or systemic toxicities by week 4, three additional subjects will be accrued to this cohort. If none of the first 3 subjects or no more than one of the six subjects in the expanded cohort experiences Grade 3 or greater local or systemic toxicities by week 4, the total dose of 4.0 x 1011 vp/day will be accepted for further clinical assessment. All four injected lesions and 1 or 2 non-injected lesions will be excised after 6 months.
Cohort B will be open for accrual to patients with 4 or more lesions once Cohort A is accepted for further clinical assessment or if Cohort A has >1/6 Grade 3 AEs. Subjects in Cohort B will receive 1.5 or 1.0 x 1011 vp/injection into each of 3 BCCs, weekly x 3, i.e. weeks 1, 2, and 3, i.e. a total dose of 4.5 or 3.0 x 1011 vp on each day of injections as outlined in Synopsis Table 2 below. If one subject in this cohort experiences Grade 3 or greater local or systemic toxicities by week 4, three additional subjects will be accrued to this cohort. If none of the first 3 subjects or no more than one of the six subjects in the expanded Cohort B1.5 or B1.0 experiences Grade 3 or greater local or systemic toxicities by week 4, that total dose of 4.5 or 3.0 x 1011 vp/day will be accepted for further clinical assessment. All three injected lesions and 1-2 non-injected lesions will be excised after 6 months.
Cohort C may be designed based on the results observed in Cohorts A and B with the agreement of the Protocol Steering Committee. If a total dose >4.5 x 1011 vp/day of injection ASN-002 on any single day or more than 3 weekly injections are to be administered, a formal amendment to the Protocol must be approved before accrual to Cohort C is permitted.
Each cohort will be assessed for safety, dose escalation and possible cohort expansion as described above. The week 4 assessment of toxicity and apparent efficacy of the first 3 subjects in each cohort will be used to determine the need to increase the size of that cohort to 6 subjects. Cohorts will be assessed clinically at 1, 2, 3 and 4 months. Treated tumors will be resected at 6 months, based on observations in the ongoing Australia trial study that inflammation persisting at 16 weeks could not be reliably distinguished from residual tumor. The 1st and 3rd secondary endpoints, histological clearance of injected and non-injected lesions, will be assessed by the Pathology Department of each clinical site. Representative slides will be submitted for possible central review to be performed at the discretion of Ascend. Each participant will also be seen one month after tumor resection to assess healing and post-surgical results Each subject may be evaluated on the 7 month visit for a second cycle of 3 weekly ASN-002 injections into new or previously untreated BCC lesions at a dose accepted for further clinical assessment. Subjects who receive a second cycle will be followed for 6 months as before, but lesion excision will be at the discretion of the investigator.
In the event study subjects in any Cohort do not proceed to histological confirmation of response per protocol, they may be replaced as long as the reason for not proceeding to histological confirmation of response per protocol was not investigational product related adverse events and so long as the Protocol Steering Committee concurs with the Sponsor that no limiting safety issues have been identified.
Depending on results, and at the discretion of the Sponsor and the Protocol Steering Committee, one Cohort may be expanded to a total of 24 subjects so long as no more than one of six subjects already included at that dose and schedule of ASN-002 experienced Grade 3 or greater local or systemic toxicities. The selection of the cohort to be expanded will be based on favorable response data from the subjects already included at that dose and schedule of ASN-002,
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Screening laboratory values as follows:
Exclusion Criteria:
Target tumor shows evidence of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with 4 or more lesions will receive 1.0 x 10\^11 vp/injection of ASN-002 into each of 4 BCCs, weekly x 3, i.e. weeks 1, 2, and 3
Biological: ASN-002
Subjects with 4 or more lesions will receive 1.5 x 10\^11 vp/injection of ASN-002 into each of 3 BCCs, weekly x 3, i.e. weeks 1, 2, and 3
Biological: ASN-002
Subjects with 4 or more lesions will receive 1.0 x 10\^11 vp/injection of ASN-002 into each of 3 BCCs, weekly x 3, i.e. weeks 1, 2, and 3
Biological: ASN-002
ASN-002 has been designed for clinical applications, especially for intratumoral administration in the treatment of various cancers. This rAd vector delivers the gene of interest, in the case of ASN-002 the human IFNγ gene, into target cells. The rAd vector in ASN-002 is replication deficient and although it infects cells, it is not able to replicate in the tumor or in normal human cells. The infected cells are able to transcribe and translate the IFNγ DNA leading to a sustained local concentration of IFNγ in the tumor mass that is designed to avoid high levels of systemic IFNγ that may be lead to unacceptable toxicity.
Safety of ASN-002 will be studied in terms of AEs reported in individuals with Basal Cell Nevus Syndrome (BCNS) receiving ASN-002 using CTCAE 4.03.
Clinical safety will assessed in terms of changes in vital signs, AEs, serious AEs (SAEs), laboratory abnormalities and withdrawals from study. Local skin and injection site reactions will be assessed in detail scoring erythema, ulceration, pain and overall severity as none, mild, moderate or severe using protocol-specific modifications of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Time frame: The assessment will be conducted at every visit after first dose, week1, week2, week 3, Months1, 2, 3, 4 and at Month 6.
Treatment efficacy in term of percentage of histological cure of BCC lesions at 6 months
At the end of the study, BCC lesions will be excised and studied under microscope to study the complete cure of BCC i.e. histological clearance
Time frame: 6 months from baseline
Clinical changes in BCCs after treatment with ASN-002 in- terms of change in lesion size (mm)
The BCC lesions will be measured in mm at baseline, after first dose at Months1, 2, 3, 4 and at Month 6 to study the change in lesion size and clinical response.
Time frame: 6 months from baseline.
The systemic effect of ASN-002 will be assessed for non-injected lesions by studying the change in lesion size from baseline to end of the study.
The non-injected BCC lesions will be measured in mm at baseline, after first dose at Months1, 2, 3, 4 and at Month 6 to study the change in lesion size and clinical response.
Time frame: 6 months from baseline
The safety in terms of the AEs reported (using CTCAE 4.03) after 6 months from first dose in retreatment cycle
Clinical safety will assessed in terms of changes in vital signs, AEs, serious AEs (SAEs), laboratory abnormalities and withdrawals from study. Local skin and injection site reactions will be assessed in detail scoring erythema, ulceration, pain and overall severity as none, mild, moderate or severe using protocol-specific modifications of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Time frame: 6 months
The systemic effect of ASN-002 will be assessed for non-injected lesions by studying the rate of histological clearance after 6 months of first dose.
At the end of the study, BCC lesions will be excised and studied under microscope to study the complete cure of BCC i.e. histological clearance
Time frame: 6 months from baseline
The efficacy will be assessed in terms of change in lesion size (mm) after 6 months from first dose in retreatment cycle
The change in lesions size in mm will be studied after 6 months from first dose in retreatment cycle.
Time frame: 6 months
Plan to share: Undecided — The decision will be taken in due course of time.
No publications or documents are linked to this record.
Started Dec 2017 (actual). Primary completion is estimated for Dec 2024, 84 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gusacitinib
Ascend Biopharmaceuticals Ltd