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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06249048




Registration number
NCT06249048
Ethics application status
Date submitted
2/02/2024
Date registered
8/02/2024

Titles & IDs
Public title
Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
Scientific title
A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab
Secondary ID [1] 0 0
STX-001-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - STX-001
Treatment: Other - Keytruda®

Experimental: Phase 1 Monotherapy (STX-001) - 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.

Experimental: Phase 1 Combination (STX-001 with Pembrolizumab) - 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.

Experimental: Phase 2 Combination (STX-001 with Pembrolizumab) - 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.


Treatment: Other: STX-001
STX-001 encapsulates a self-replicating RNA encoded for IL-12, contained within an LNP for intratumoral injection.

Treatment: Other: Keytruda®
Pembrolizumab (Keytruda USPI 2023) is a marketed PD-1 blocking humanized monoclonal IgG4 kappa antibody.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and nature of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients with advanced solid tumors.
Timepoint [1] 0 0
From time of informed consent until 30 days after the last dose of investigational product (STX-001).
Primary outcome [2] 0 0
Occurrence of changes from baseline in patients' clinical safety laboratory values and vital signs to assess the safety and tolerability of STX-001.
Timepoint [2] 0 0
From time of informed consent until 30 days after the last dose of investigational product (STX-001).
Secondary outcome [1] 0 0
Assessment of PK in patients dosed with STX-001
Timepoint [1] 0 0
From time of informed consent until 30 days after the last dose of investigational product (STX-001).
Secondary outcome [2] 0 0
Number and nature of preliminary antitumor activity of STX-001.
Timepoint [2] 0 0
From time of informed consent until 30 days after the last dose of investigational product (STX-001).
Secondary outcome [3] 0 0
Number and nature of preliminary antitumor activity of STX-001 in combination with pembrolizumab.
Timepoint [3] 0 0
From time of informed consent until 30 days after the last dose of investigational product (STX-001).
Secondary outcome [4] 0 0
Number and nature of preliminary antitumor activity of STX-001.
Timepoint [4] 0 0
From time of informed consent until 18 months after the last dose of investigational product (STX-001).
Secondary outcome [5] 0 0
Number and nature of preliminary antitumor activity of STX-001 in combination with pembrolizumab.
Timepoint [5] 0 0
From time of informed consent until 18 months after the last dose of investigational product (STX-001).
Secondary outcome [6] 0 0
Occurrence of TEAEs, SAEs, and AESIs graded according to NCI CTCAE v5.0
Timepoint [6] 0 0
From time of informed consent until 30 days after the last dose of investigational product (STX-001).
Secondary outcome [7] 0 0
Occurrence of changes from baseline in patients' clinical safety laboratory values and vital signs to assess the safety and tolerability of STX-001.in combination with pembrolizumab.
Timepoint [7] 0 0
From time of informed consent until 30 days after the last dose of investigational product (STX-001).
Secondary outcome [8] 0 0
Objective Response Rate (ORR) in patients with advanced solid tumors.
Timepoint [8] 0 0
From time of informed consent until 30 days after the last dose of investigational product (STX-001).

Eligibility
Key inclusion criteria
General

* = 18 years of age at the time of screening.
* Mentally competent and able to understand and sign the informed consent form (ICF).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of = 12 weeks per the Investigator.
* Body weight ? 40 kg.
* At least 4 weeks from any prior major surgery.
* Willing and able to provide blood samples prior to the start of this study.
* Has a tumor lesion amenable to injection, must be accessible for pre and post injection biopsy, and the patient must be willing to consent to biopsy, if deemed safe by the Investigator.
* Laboratory values (Hematology): Absolute neutrophil count = 1,000 cells/mm3; Platelet count = 75,000 cells/mm3; Hemoglobin = 8.0 g/dL.
* Laboratory values (Renal): Serum creatinine < 1.5 × upper limit of normal (ULN) or creatinine clearance = 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation
* Laboratory values (Coagulation): Prothrombin/International Normalized Ratio (PT/INR) or prothrombin time must be < 1.5 × ULN;
* Activated partial thromboplastin time (aPTT) = 1.5 × ULN unless undergoing anticoagulation therapy.
* Laboratory values (Liver): Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 × ULN; Bilirubin = 2 × ULN or = 5 × ULN with liver metastasis.

Phase 1

* Histologically or cytologically documented, locally advanced, or metastatic solid tumor.
* Disease progression confirmed by imaging or other objective evidence after having received standard treatment or patients with refractory solid tumors. Patients must have progressed or are intolerant of at least one line of prior therapy.

Phase 2 Inclusion Criteria (TNBC):

* Histologically or cytologically documented findings consistent with TNBC not amenable to curative surgery, radiation, or other therapy.
* Prior treatment (for advanced, metastatic or [neo]adjuvant) should have included a taxane and/or anthracycline-based therapy and, where appropriate, an approved checkpoint inhibitor.
* Has disease other than the injected lesion that is measurable by RECIST 1.1.

Phase 2 Inclusion Criteria (melanoma):

* Histologically or cytologically documented findings consistent with advanced melanoma not amenable to curative surgery, radiation, or other therapy. Uveal melanoma is excluded.
* Patients who are not candidates for or have refused available therapies are also eligible.
* Received an anti-programmed death-1 (PD-1) / programmed death ligand-1 (PD-L1) inhibitor as monotherapy or in combination with anti-cytotoxic lymphocyte associated protein 4 (CTLA-4) inhibitor and have either primary or secondary checkpoint inhibitor resistance as per Society for Immunotherapy of Cancer (SITC) consensus definition, unless deemed intolerable by the investigator. Patients with BRAF V600E mutant melanoma should have received a BRAF inhibitor as monotherapy or in combination with other targeted agents (mitogen-activated protein kinase [MAPK] kinase [MEK] inhibitors), unless deemed intolerable by the investigator.
* Has disease other than the injected lesion that is measurable by RECIST 1.1.

Phase 1 and 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of primary immune deficiency.
* History of autoimmune disease and/or requiring immunosuppression (except hypothyroidism).
* History of History of Grade 3 or higher immune-related adverse events. Patient may be enrolled with Medical Monitor approval.
* History of solid organ transplant and taking immunosuppressive medications.
* 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.

Recent medical concerns exclusions:

* Prior direct radiation therapy to the tumor lesion to be injected.
* Active use of systemic anticoagulants
* Evidence of active infection requiring intravenous (IV) antibiotics during screening requiring therapy within 7 days prior to Cycle 1 Day 1.
* Active uncontrolled bleeding, or a bleeding diathesis within 7 days prior to Cycle 1 Day 1.
* Serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to Cycle 1 Day 1.
* Known human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
* Virology evaluation should be conducted at screening to include serum HIV antibody, HBc antibody, HBsAg antigen, and HCV antibody. Patients with a positive antibody evaluation for HCV and/or HBc should undergo evaluation to measure HCV RNA or HBV DNA, respectively.
* Untreated central nervous system tumor, epidural tumor or metastasis, or brain metastasis. Patients with any primary Central Nervous System (CNS) malignancy including glioma and current, active, progressing CNS malignancy, including carcinomatosis meningitis are excluded.
* Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the screening period and off systemic steroids (for at least 2 weeks prior to first dose).
* Another primary malignancy that has not been treated with curative intent, except for non-metastatic cutaneous basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.
* Serious illness considered by the Investigator as incompatible with participating in this clinical study.
* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.
* Prior IL-12 therapy.
* Receipt of any vaccine within 30 days prior to the first dose of study treatment.
* Use of another anticancer therapy within 3 weeks prior to Cycle 1 Day 1 or 5 half-lives, whichever is shorter.
* Previously enrolled in this study.
* Actively enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the follow-up component of an interventional study.
* Known severe hypersensitivity (Grade = 3) to study treatment or any of the excipients of the products.
* Known psychiatric or substance use disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
* Currently pregnant (confirmed with positive pregnancy test), breast-feeding or planning to become pregnant within 60 days following treatment. For women of childbearing potential (WOCBP), a negative serum beta-human chorionic gonadotropin (ß-HCG) result must be available within a 72 hour window before the first treatment dose.
* Women of childbearing potential not willing to use a highly effective method of contraception.
* Unwilling or unable to follow protocol requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2028
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melanoma Institute Australia - Wollstonecraft
Recruitment postcode(s) [1] 0 0
- Wollstonecraft
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Strand Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tasuku Kitada, PhD
Address 0 0
Strand Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tasuku Kitada, PhD
Address 0 0
Country 0 0
Phone 0 0
617-993-9271
Fax 0 0
Email 0 0
tasuku.kitada@strandtx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06249048