Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Bowen's Disease

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cohort A: STP705 10 μg dose, intradermal injection, given once a week for up to 6 weeks

Cohort B: STP705 20 μg dose, intradermal injection, given once a week for up to 6 weeks

Cohort C: STP705 30 μg dose, intradermal injection, given once a week for up to 6 weeks

Cohort D: STP705 60 μg dose, intradermal injection, given once a week for up to 6 weeks

Cohort E: STP705 120 μg dose, intradermal injection, given once a week for up to 6 weeks

STP705

Kush Dhody, MBBS, MS, CCRA

Brian Berman, MD, PhD

This is an open label, dose escalation study to evaluate the safety and efficacy of intralesional injection of STP705 in adult patients with Cutaneous Squamous Cell Carcinoma in situ (isSCC, Bowen's disease). The purpose of this trial is to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as Intralesional injection in subjects with isSCC.

Goals:

* To determine the safe and effective recommended dose of STP705 for the treatment of isSCC.
* Analysis of biomarkers common to isSCC formation pathway including TGF-β1 and COX-2.

This open label, dose escalation study is designed to evaluate the safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with cutaneous in situ squamous cell carcinoma (isSCC).

The primary objective of this study is to evaluate the safety, tolerability, and efficacy of various doses of STP705 administered as an Intralesional injection in subjects with cutaneous squamous cell carcinoma in situ skin cancer (isSCC). This study seeks to establish a safe and effective recommended dose of STP705 for the treatment of isSCC. Expression of biomarkers common to the isSCC formation pathway, including TGF-β1 and COX-2, will be evaluated.

The primary endpoint will be the proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT). Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.

Secondary endpoints will include i) time to histological clearance of treated isSCC lesion over the 6 week treatment period, ii) proportion of participants with complete clinical clearance of treated isSCC lesion based on investigator assessment at the End of Treatment (EOT), iii) time to complete clinical clearance of treated isSCC lesion based on investigator assessment over the 6 week treatment period, and iv) the change in size of the treated isSCC lesion over the 6 week treatment period.

Safety and tolerability will be assessed by the number of incidence of adverse events (AEs) and serious adverse events (SAEs); the incidence of AEs and SAEs leading to discontinuation of trial medication; the incidence and severity of Local Skin Response (LSR); hypopigmentation and hyperpigmentation following treatment; and the tolerability of repeated Intralesional administration of STP705 as assessed by investigator-evaluation of injection site reactions for all patients and within each cohort.

In addition, safety measures will include clinically relevant changes or new abnormal findings in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables.

25 adult patients are planned to be enrolled in the study. They will be divided equally among 5 cohorts (10, 20, 30, 60 and 120 μg dose levels) of 5 subjects each. Enrollment of the first two subjects in each dosing cohort will be staggered by at least 48 hours. Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the isSCC lesion. The participants will receive injections of STP705 once a week for up to 6 weeks. The clinician will evaluate the tumor for clinical changes and reduction in size at each treatment visit for up to 6 weeks. If during the 6 weeks of treatment there is complete clinical clearance of the tumor, the treatments will end. At the End of Treatment visit, the residual tumor, or former tumor location will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.

If any of the SAEs or dose limiting toxicities outlined above has occurred, the Data Safety Monitoring Board (DSMB) will conduct independent review of the data and will make a final decision for dose escalation to the next cohort.

Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the isSCC lesion. The participants will receive injections of STP705 once a week for up to 6 weeks. The clinician will evaluate the tumor for clinical changes and reduction in size at each treatment visit for up to 6 weeks. If during the 6 weeks of treatment there is Complete Clinical Clearance of the tumor, the treatments will end. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.

Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC

An Open Label, Dose Escalation Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).

Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.

Change in size of the treated isSCC lesion over the 6 week treatment period. A base line assessment of lesion size will be made by investigator at T1 (first visit, Day 0). The change in size will be assessed every week until the surgical excision of isSCC at the End of Treatment visit (EOT, Day 42) .

Amarex Clinical Research

Sirnaomics

Symptoms and General Pathology

Digestive System Diseases

Cholangiocarcinoma

Neoplasm Metastasis

Carcinoma, Hepatocellular

Neoplastic Processes

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Bile Duct Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle.

Francois Lebel, MD

This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.

Goals:

1. To determine the MTD or RP2D of STP705 when administered intratumorally into cholangiocarcinoma, hepatocellular carcinoma, or liver metastasis.
2. To establish the dose of STP705 recommended for future phase 2 studies when administered intratumorally.

This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of various doses of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis.

The primary objective of this study is to determine the MTD or RP2D of STP705 and to establish the dose of STP705 recommended for future phase 2 studies when administered intratumorally.

A total of up to 30 patients will be enrolled in the dose escalation phase of the study. In addition, once the MTD or recommended phase 2 dose has been established, up to 20 additional patients maybe enrolled to confirm safety and explore anti-tumor activity.

Up to five dose levels will be explored (20,40,80,160,320 μg dose levels) and will depend on the number and intensity of observed toxicity. Intermediate doses maybe explored during escalation period.

It will follow an accelerated titration design, enrolling 1 patient per dose cohort and will expand to a standard 3+3 design after.

In the accelearted titration a Grade 2 SE triggers the transition to the 3+3 part of the study. The 3+3 part of the study will start at dose level 160μg.

Subjects will be evaluated for DLTs in the first cycle of treatment and graded aacording to NCI CTCAE v5. A cycle is 28 days.

Accelerated titration design followed by expansion to standard 3+3 design

Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy

Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy

Recommended starting dose \& dose escalation

Translational Drug Development

Carcinoma, Basal Cell

Neoplasms, Basal Cell

Cohort A: STP705 30 μg dose, localized injection, given once a week for 6 weeks

Cohort B: STP705 60 μg dose, localized injection, given once a week for 6 weeks

Cohort C: STP705 90 μg dose, localized injection, given once a week for 6 weeks

Cohort D: STP705 120 μg dose, localized injection, given once a week for 6 weeks

Cohort E: STP705 180 μg dose, localized injection, given once a week for 6 weeks

Cohort F: STP705 240 μg dose, localized injection, given once a week for 6 weeks

Cohort G: STP705 320 μg dose, localized injection, given once a week for 6 weeks

Dry powder for intra-and peri-lesional injection.

Mark Nestor, MD, PhD

This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with Basal Cell Carcinoma (BCC).

Goals:

* To determine the safe and effective recommended dose of STP705 for the treatment of basal cell carcinoma.
* Analysis of biomarkers common to BCC formation pathway including TGF-β1 and COX-2.

Basal cell carcinoma occurs most often on areas of the skin that are exposed to the sun, such as head and neck. The most commonly found clinical feature of Basal Cell Carcinoma (BCC) is an elevated tumor with a pearly and translucent margin and telangiectasia. The color may vary widely from nearly normal skin color to erythematous to violaceous and may also be pigmented. BCC may also resemble noncancerous skin conditions such as eczema or psoriasis. The majority of these cancers occur on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation.

The STP705 drug substance (STP705) is composed of two siRNA oligonucleotides, targeting the expression of TGF-β1 and Cox-2 mRNA respectively. Along with the HKP-enhanced delivery system, the combination is expected to downregulate TGF-β1 and COX-2 expression resulting in the inhibition of tumor growth and provide an alternative non-invasive approach for the treatment of BCC.

This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with BCC. This study seeks to establish a safe and effective recommended dose of STP705 for the treatment of BCC. The clinician will evaluate the change in tumor size at each treatment visit. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. Expression of biomarkers common to the BCC formation pathway, including TGF-β1 and COX-2, will be evaluated.

Safety and tolerability will be assessed by the number of incidence of adverse events (AEs) and serious adverse events (SAEs); the incidence of AEs and SAEs leading to discontinuation of trial medication; the incidence and severity of Local Skin Response (LSR); hypopigmentation and hyperpigmentation following treatment; and the tolerability of repeated localized administration of STP705 as assessed by investigator-evaluation of injection site reactions for all patients and within each cohort.

The study plans to enroll approximately 35 adult patients at up to 3 clinical sites in the United States. The 35 patients will be divided equally among 7 cohorts (30, 60, 90, 120, 180, 240, and 320 μg dose level) of 5 patients each.

Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the BCC lesion. The participants will receive injections of STP705 once a week for 6 weeks. The clinician will evaluate the change in tumor size at each treatment visit. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis.

In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.

Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell Carcinoma

An Open Label, Dose Escalation Study to Evaluate the Safety and Efficacy of Localized Injection of STP705 in Adult Patients With Basal Cell Carcinoma

Histological clearance (HC) will be defined as the absence of detectable evidence of BCC tumor cell nests as determined by central pathology review.

A base line assessment of lesion clinical diameter will be made by investigator at T1 (first visit). The change in size will be assessed every week until the surgical excision of BCC at the End of Treatment (EOT) visit.

STP705 30 μg dose, intralesional injection, given once a week for 6 weeks.

STP705 60 μg dose, intralesional injection, given once a week for 6 weeks.

STP705 90 μg dose, intralesional injection, given once a week for 6 weeks.

Placebo (normal saline), intralesional injection, given once a week for 6 weeks.

STP705 selected dose 1, intralesional injection, given once a week for 6 weeks.

STP705 selected dose 2, intralesional injection, given once a week for 6 weeks.

The STP705 drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively.

Placebo Saline

Mark Nestor, MD

David Goldberg

Michael Gold, MD

Edward Lain, MD

Kenneth Beer, MD

Brenda LaTowsky, MD

Edward Primka, MD

Girish Munavalli, MD

Brian Jiang, MD

Megan Couvillion, MD

Mark Ling, MD

The purpose of this trial is to evaluate safety, tolerability and efficacy of various doses of STP705 administered as intralesional injection in subjects with cutaneous squamous cell carcinoma (in situ) skin cancer (isSCC).

This is a two-part, double-blind, randomized, placebo-controlled study designed to evaluate safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with isSCC.

A total of up to 100 eligible subjects will be enrolled. Enrolled subjects will be randomly allocated to receive STP705 or placebo injection once weekly for 6 weeks.

After 6 weeks, the lesion will be excised.

In part 1 (dose ranging study): 40 subjects will be randomized to receive 1 of the 3 STP705 doses or placebo.

An interim analysis will be done after all subjects have completed end of treatment (EOT) visits to determine 2 selected dose levels of STP705 to be used in part of the study.

In part 2: 60 additional subjects will be randomized to receive 1 of the 2 selected doses (from part 1) or placebo.

In both parts at the End of Treatment (EOT), the lesion will be excised.

Part 1: 40 subjects randomized in a 1:1:1:1 ratio to receive 6 weeks of treatment of placebo, 30 ug, 60 ug, or 90 ug of STP705. Enrollment will be temporarily stopped after the 40th subject. Interim Analysis will be done for dose response assessment and selection of the 2 doses for Part 2 of the study.

Part 2: 60 additional subjects will be randomized in a 1:1:1 ratio to receive placebo or one of the 2 selected STP705 doses.

This is a double-blind study. All subjects, investigators, and site staff (except unblinded pharmacist or designated site staff) in the study will be blinded to the treatment assignment.

A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).

Change in size of the treated isSCC lesion over the 6-week treatment period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC	NCT04293679	Bowen's Disease Cutaneous Squam...	STP705	18 Years -	Sirnaomics
Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy	NCT04676633	Hepatocellular ... Liver Metastase... Cholangiocarcin...	STP705	18 Years -	Sirnaomics
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell Carcinoma	NCT04669808	Basal Cell Carc...	STP705	18 Years -	Sirnaomics
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC	NCT04293679	Bowen's Disease Cutaneous Squam...	STP705	18 Years -	Sirnaomics
A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC	NCT04844983	Squamous Cell C...	STP705 Placebo Saline	18 Years -	Sirnaomics
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell Carcinoma	NCT04669808	Basal Cell Carc...	STP705	18 Years -	Sirnaomics
Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy	NCT04676633	Hepatocellular ... Liver Metastase... Cholangiocarcin...	STP705	18 Years -	Sirnaomics
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell Carcinoma	NCT04669808	Basal Cell Carc...	STP705	18 Years -	Sirnaomics

Spots Global Cancer Trial Database for stp705

Every month we try and update this database with for stp705 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for stp705

Every month we try and update this database with for stp705 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for stp705 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.