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Squamous Cell CarcinomaPhase 1/2NCT05858229

Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.

A Phase 1/2 study testing RP1 in people with Squamous Cell Carcinoma and RP1, run by Sherrif Ibrahim at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a Phase 1b, single-center, open-label study, evaluating efficacy and safety of RP1 for the treatment of resectable cutaneous Squamous Cell Carcinoma in up to 12 evaluable patients. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Squamous Cell Carcinoma, RP1
What is being tested?
RP1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
16 Jun 2023to Jun 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol.
  • Male or female ≥ 18 years of age on the day of signed informed consent.
  • Patients must be treatment naïve in the target lesion(s).
  • Patients for whom surgical treatment of lesions is clinically indicated.
  • At least one measurable histologically confirmed cutaneous tumor of ≥ 1.0 cm in longest diameter and ≤ 3.0 cm with clinically visible residual tumor. More than one tumor may be treated including newly diagnosed lesions.
  • ECOG performance status ≤ 1.
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  • Adequate hepatic function, including both of the following:
  • Adequate hematologic function
  • Adequate coagulation parameters, including both of the following:
  • Anticipated life expectancy > 2 years
  • Have provided either formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, obtained within four months prior to enrollment, with an associated pathology report,. Biopsy can be either by punch or shave method.. A fresh biopsy is required at screening if an archival biopsy (within four months prior to enrollment) is not available.

Who cannot join

  • Prior treatment with an oncolytic therapy or intratumoral immunotherapy (e.g. TLR agonists, etc.).
  • Patients with known visceral metastases.
  • Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis). Patients who require intermittent or chronic use of systemic (oral or IV) antiviral agents with known antiherpetic activity (e.g., acyclovir, valacyclovir, famciclovir, ganciclovir, valganciclovir). Note: Patients with sporadic cold sores may be enrolled as long as no active cold sores are present at the time of first dose of RP1.
  • Had systemic infection requiring IV antibiotics or other serious infection within 14 days prior to dosing.
  • Patients with an active, known, or suspected autoimmune disease that requires systemic immunosuppressive treatment. Patients with vitiligo, childhood asthma that has resolved, type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or psoriasis that does not require systemic treatment are permitted to enroll.
  • Patients with a history of any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating the presence of the virus, e.g., hepatitis B surface antigen [HBsAg] positive or hepatitis C antibody (anti-HCV) positive (except if HCV RNA negative), or human immunodeficiency virus (HIV) positive. Patients with a history of HBV or HCV infection must have undetectable viral load within three months of study entry. (Note: No testing for HBV, HCV, or HIV is required unless mandated by local health authorities).
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  • Had clinically significant cardiovascular disease within 6 months from first dose of study drug, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction or stroke/transient ischemic attack or significant cardiac arrhythmias associated with hemodynamic instability.
  • Radiation therapy within 14 days of first dose of RP1, or topical therapy within 30 days of RP1, is not allowed. The patient must have recovered from all AEs due to previous therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 1 or baseline. Participants with unresolved radiation-induced xerostomia are eligible.
  • Documented history of allergic reactions or acute hypersensitivity reaction attributed to RP1 or to any of the excipients.
  • Patients with solid organ transplantation
  • Tumors for which margins are not well defined, either clinically or based on pathologic report (Ill-defined tumors).
  • Tumors where invasion beyond the subcutaneous fat is suspected
  • Any co-morbidity, physical examination finding, metabolic dysfunction, or clinical laboratory abnormality that, in the opinion of the investigator, renders the patient unsuitable for participation due to safety risks and/or potential to affect interpretation of results of the study.
  • Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within two weeks prior to the first dose of RP1 and throughout the study as per Section 5.10.2.
  • Any active malignancy within three years of the date of first planned dose of RP1, except for the specific cancer under investigation in this study and tumors with negligible risk of metastasis or death, squamous cell carcinoma in situ (SCCIS), basal cell carcinoma (BCC) or other small CSSS, melanoma in situ, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, low-risk early stage prostate adenocarcinoma (T1T2aN0M0), Gleason score ≤ 6, and prostate specific antigen (PSA) ≤ 10 ng/mL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of > 12 months for which the management plan is active surveillance. Patients with hematologic malignancies are excluded, except for patients with chronic lymphocytic leukemia (CLL) who are considered stable and not on active treatment.
  • Any acute or chronic psychiatric problems, alcohol abuse, or substance abuse disorders that, in the opinion of the investigator, would interfere with the patient's ability to comply with the requirements of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rochester Dermatologic Surgery

    Victor, New York, 14564

Other trials in United States

About this study

Official title: A Phase 1B Study of Intralesional Injection of RP1 in Patients With Resectable Cutaneous SCC

This is a Phase 1b, single-center, open-label study, evaluating efficacy and safety of RP1 for the treatment of resectable cutaneous Squamous Cell Carcinoma in up to 12 evaluable patients. In this study, patients will receive RP1 via direct intratumoral (IT) injection into superficial cutaneous solid tumors to assess the safety and tolerability as well efficacy of RP1 treatment. The primary efficacy population is up to 12 evaluable patients with resectable CSCC. The enrollment of patients with CSCC will determine study duration.

Being tested
RP1
Keywords
squamous cell carcinoma, RP1, intralesional treatment, non-surgical option
Medical subject headings
Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RP1Drug

    Recombinant Herpes Simplex Virus Type 1 - hGM CSF/GALV-GP-R-

Study groups in NCT05858229
Study groupRoleWhat they receive
TreatmentExperimentalPatients will receive RP1 via direct intratumoral (IT) injection into superficial cutaneous solid tumors to assess the safety and tolerability as well efficacy of RP1 treatment. The primary efficacy population is up to 12 evaluable patients with resectable CSCC.
Receives: Drug: RP1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate degree of pathologic response at 16 weeks.

    The proportion of patients with pathologic complete response (pCR) per Immune-Related Pathologic Response Criteria' (irPRC) criteria: 0% residual viable tumor (RVT)] remaining in post-therapy specimen (no signs of cancer) in tissue samples removed during surgery.

    Measured: 16 weeks

Secondary outcomes (4)

  1. Evaluate the duration of response

    To estimate duration of response (DOR) for CSCC and all patients treated, by investigator review.

    Measured: 2 years

  2. Evaluate presence of disease

    To estimate the progression-free (PFS) for CSCC and all patients treated.

    Measured: 2 years

  3. To estimate the complete response (CR) rate

    Estimate the complete response (CR) rate for CSCC and all patients treated.

    Measured: 2 years

  4. To evaluate the disease control rate (DCR)

    To evaluate the disease control rate (DCR) for CSCC and all patients treated.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2023
  2. Study start16 Jun 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05858229
Sponsor's protocol ID
IST2021-RP1-08
Status last verified
Dec 2025
First submitted
17 Apr 2023
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bateman A, Bullough F, Murphy S, Emiliusen L, Lavillette D, Cosset FL, Cattaneo R, Russell SJ, Vile RG. Fusogenic membrane glycoproteins as a novel class of genes for the local and immune-mediated control of tumor growth. Cancer Res. 2000 Mar 15;60(6):1492-7.

    PubMed 10749110

  • Bateman AR, Harrington KJ, Kottke T, Ahmed A, Melcher AA, Gough MJ, Linardakis E, Riddle D, Dietz A, Lohse CM, Strome S, Peterson T, Simari R, Vile RG. Viral fusogenic membrane glycoproteins kill solid tumor cells by nonapoptotic mechanisms that promote cross presentation of tumor antigens by dendritic cells. Cancer Res. 2002 Nov 15;62(22):6566-78.

    PubMed 12438252

  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PubMed 7165009

  • Patel IJ, Rahim S, Davidson JC, Hanks SE, Tam AL, Walker TG, Wilkins LR, Sarode R, Weinberg I. Society of Interventional Radiology Consensus Guidelines for the Periprocedural Management of Thrombotic and Bleeding Risk in Patients Undergoing Percutaneous Image-Guided Interventions-Part II: Recommendations: Endorsed by the Canadian Association for Interventional Radiology and the Cardiovascular and Interventional Radiological Society of Europe. J Vasc Interv Radiol. 2019 Aug;30(8):1168-1184.e1. doi: 10.1016/j.jvir.2019.04.017. Epub 2019 Jun 20. No abstract available.

    PubMed 31229333

  • Simpson GR, Han Z, Liu B, Wang Y, Campbell G, Coffin RS. Combination of a fusogenic glycoprotein, prodrug activation, and oncolytic herpes simplex virus for enhanced local tumor control. Cancer Res. 2006 May 1;66(9):4835-42. doi: 10.1158/0008-5472.CAN-05-4352.

    PubMed 16651439

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RP1 in people with Squamous Cell Carcinoma and RP1, run by Sherrif Ibrahim 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 11 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

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?

Evaluate degree of pathologic response at 16 weeks. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05858229, which also lists 5 linked publications.

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 31 Dec 2025.

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