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Virus Therapy

STX-001 + Keytruda for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by Strand Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age at the time of screening
Mentally competent and able to understand and sign the informed consent form (ICF)
Must not have
Cardiovascular exclusions: Medical history of an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months; medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a cardiac arrhythmia that required treatment within the past 12 months; medical history of myocardial infarction or unstable angina within 6 months before Cycle 1 Day 1; QTcF prolongation to > 470 ms in women and > 450 ms in men based on a 12-lead electrocardiogram (ECG) in triplicate using the Fridericia formula: QTc = QT / RR1/3
Prior IL-12 therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of informed consent until 30 days after the last dose of investigational product (stx-001).
Awards & highlights

Summary

This trial is testing a new treatment called STX-001 in patients with advanced solid tumors. They will be given the treatment through an injection into the tumor and will be monitored for safety, how the

Who is the study for?
This trial is for individuals with advanced solid tumors. Participants should be adults who have tried other treatments that didn't work or aren't suitable. They must be able to receive injections directly into their tumor and can handle biopsies. People with immune system disorders, certain blood conditions, or those on steroids may not qualify.
What is being tested?
The study tests STX-001 as a solo treatment and combined with Pembrolizumab (Keytruda®), an existing cancer drug. It's given by injection straight into the tumor to see how safe it is, how the body reacts to it, and if it helps against the cancer.
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms, fatigue, changes in appetite, skin issues like rash or itching, nausea and possibly more serious immune-related effects due to Pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I understand the study and can sign the consent form.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My body weight is over 40 kg.
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My cancer is advanced and has been confirmed by lab tests.
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My cancer has worsened after standard treatment or I cannot tolerate it.
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My kidney function tests are within normal limits.
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My liver function tests are within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously received IL-12 therapy.
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I am not willing to use effective birth control.
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I have had a solid organ transplant.
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I have HIV, active hepatitis B, or hepatitis C.
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I haven't taken any cancer treatments in the last 3 weeks or 5 half-lives, whichever is shorter.
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I do not have any serious wounds or non-healing fractures as of the last week.
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I have an untreated brain tumor or cancer that has spread to my brain.
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I have an autoimmune disease other than hypothyroidism or need immunosuppression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of informed consent until 30 days after the last dose of investigational product (stx-001).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of informed consent until 30 days after the last dose of investigational product (stx-001). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and nature of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in subjects with advanced solid tumors.
Occurrence of changes from baseline in subjects' clinical safety laboratory values and vital signs to assess the safety and tolerability of STX-001.
Secondary outcome measures
Assessment of PK in patients dosed with STX-001
Number and nature of preliminary antitumor activity of STX-001 in combination with pembrolizumab.
Number and nature of preliminary antitumor activity of STX-001.
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase 2 Combination (STX-001 with Pembrolizumab)Experimental Treatment2 Interventions
Phase 2 consists of dose expansion cohorts in patients with 2 defined cancer types: triple negative breast cancer (TNBC) and melanoma. Phase 2 will evaluate STX-001 in combination with pembrolizumab; the recommended Phase 2 dose (RP2D) of STX-001 will be selected based on analysis of the totality of data from Phase 1.
Group II: Phase 1 Monotherapy (STX-001)Experimental Treatment1 Intervention
A Phase 1, first-in-human (FIH), multiple ascending STX-001 dose administration to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity in patients with advanced cancers. Consists of 4 planned dose escalation cohorts (Cohorts 1m) of STX-001 with new patients enrolled in each dose escalation cohort.
Group III: Phase 1 Combination (STX-001 with Pembrolizumab)Experimental Treatment2 Interventions
A Phase 1, first-in-human (FIH), multiple ascending STX-001 dose administration, in combination with pembrolizumab, to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity in patients with advanced cancers. Consists of 4 planned dose escalation cohorts (Cohorts 1c) of STX-001 with new patients enrolled in each dose escalation cohort.

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Who is running the clinical trial?

Strand Therapeutics Inc.Lead Sponsor
Tasuku A Kitada, PhDStudy ChairStrand Therapeutics
~72 spots leftby May 2027
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