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Anti-sense oligonucleotide

STP705 for Liver Cancer

Phase 1
Waitlist Available
Research Sponsored by Sirnaomics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acceptable hematologic status: Hemoglobin ≥ 8 g/dL (a transfusion is allowed if Hemoglobin stays stable thereafter), Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3, Platelet count ≥100,000 plt/mm3 x 109/ L (≥ 65,000 if low platelet counts are due to splenic sequestration and portal hypertension), Urinalysis with no clinically significant abnormalities, Acceptable coagulation status with partial thromboplastin time (PTT) and International Normalized Ratio (INR) ≤1.5 times upper limit of normal, Subject has adequate vitamin D level, as defined by serum total 25-Hydroxyvitamin D [25(OH)D] ≥ 20 to < 60 ng/mL, Completion of all previous treatments (including surgery, systemic chemotherapy and radiotherapy), as well as supportive care (including transfusion of blood, blood components and granulocyte colony-stimulation factor [G-CSF] treatment) at least 3 weeks before screening (6 weeks for nitrosoureas or mitomycin C), with no signs or symptoms of acute toxicity > Grade 1 (except alopecia), For men and women of child-producing potential, the use of effective contraceptive methods during the study, No aspirin for ≥ 5 days in advance of intra-tumoral administration, as well as discontinuation of antiplatelet and anticoagulant medications for the appropriate amount of time
Have at least one liver tumor or metastasis (≤ 5 cm in size) that is not sub-capsular and not near any major blood vessel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 day cycle
Awards & highlights

Study Summary

This trial is testing a new drug, STP705, for safety and effectiveness in treating cholangiocarcinoma, hepatocellular carcinoma, or liver metastasis.

Who is the study for?
This trial is for adults over 18 with advanced or inoperable cholangiocarcinoma, hepatocellular carcinoma, or solid tumors with liver metastases that don't respond to standard treatments. Participants must have a life expectancy of at least 3 months, acceptable organ function, no more than 7 liver lesions, and be able to receive injections directly into the tumor. They should not have had recent major surgeries or certain medical conditions like severe heart disease.Check my eligibility
What is being tested?
The study tests STP705 given directly into liver tumors. It's an open-label trial meaning everyone knows what treatment they're getting. The goals are to find the highest dose patients can take without serious side effects (MTD) and decide on a recommended phase 2 dose (RP2D).See study design
What are the potential side effects?
While specific side effects of STP705 aren't listed here, common ones from intratumoral cancer therapies include pain at injection site, inflammation around the tumor area, fever-like symptoms such as chills and fatigue; potential allergic reactions; and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a liver tumor or metastasis smaller than 5 cm, not near the liver surface or major blood vessels.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I have 7 or fewer liver lesions.
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My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.
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My kidney function is within the normal range.
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My liver functions are within the required limits, even with cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 day cycle
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 day cycle for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Limited Dose Toxicity (LTD)
Maximum Tolerated Dose (MTD)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5: STP705 320 μg doseExperimental Treatment1 Intervention
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.
Group II: Cohort 4: STP705 160 μg doseExperimental Treatment1 Intervention
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.
Group III: Cohort 3: STP705 80 μg doseExperimental Treatment1 Intervention
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.
Group IV: Cohort 2: STP705 40 μg doseExperimental Treatment1 Intervention
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.
Group V: Cohort 1: STP705 20 μg doseExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
STP705
2022
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

SirnaomicsLead Sponsor
11 Previous Clinical Trials
332 Total Patients Enrolled
Translational Drug DevelopmentOTHER
18 Previous Clinical Trials
1,015 Total Patients Enrolled
Francois Lebel, MDStudy DirectorChief Medical Officer
5 Previous Clinical Trials
107 Total Patients Enrolled

Media Library

STP705 (Anti-sense oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT04676633 — Phase 1
Bile Duct Cancer Research Study Groups: Cohort 3: STP705 80 μg dose, Cohort 2: STP705 40 μg dose, Cohort 1: STP705 20 μg dose, Cohort 4: STP705 160 μg dose, Cohort 5: STP705 320 μg dose
Bile Duct Cancer Clinical Trial 2023: STP705 Highlights & Side Effects. Trial Name: NCT04676633 — Phase 1
STP705 (Anti-sense oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04676633 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently an opportunity to join this experiment?

"According to clinicaltrials.gov the study is currently recruiting participants, with its first posting on March 1st 2021 and most recent update occurring October 24th 2022."

Answered by AI

What is the maximum capacity of participants for this trial?

"The research trial requires 50 participants that meet the eligibility criteria to be successful. This project is a joint venture between Sirnaomics and two medical centres; USC Norris Comprehensive Cancer Center in Los Angeles, California and Honor Health in Scottsdale, Arizona."

Answered by AI

In what geographic regions is this clinical trial administered?

"USC Norris Comprehensive Cancer Center in Los Angeles, Honor Health in Scottsdale, and Atlantic Health System in Morristown are three of the four sites that are currently recruiting participants for this trial. The fourth location is yet to be announced."

Answered by AI

What have the safety assessments determined regarding STP705?

"Due to minimal clinical data related to both efficacy and safety, STP705 was assigned a score of 1 on our internal scale."

Answered by AI

Who else is applying?

How old are they?
65+
What site did they apply to?
USC Norris Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy
2021. "Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04676633.
~1 spots leftby Apr 2025
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