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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04799054
Registration number
NCT04799054
Ethics application status
Date submitted
26/02/2021
Date registered
16/03/2021
Date last updated
30/05/2024
Titles & IDs
Public title
A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors
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Scientific title
Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
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Secondary ID [1]
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transcendIT-101
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Secondary ID [2]
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TCTLR-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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Locally Advanced Solid Tumor
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Metastatic Solid Tumor
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Head and Neck Squamous Cell Carcinoma HNSCC
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HPV-associated Cancers
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Neoadjuvant Melanoma
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Neoadjuvant Cutaneous Squamous Cell Carcinoma (cSCC)
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TransCon TLR7/8 Agonist
Treatment: Drugs - Pembrolizumab
Experimental: Part 1 Monotherapy Dose Escalation and Optimization: TransCon TLR7/8 Agonist - TransCon TLR7/8 Agonist in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D.
Experimental: Part 2 Combination Dose Escalation and Optimization: TransCon TLR7/8 Agonist with Pembrolizumab - TransCon TLR7/8 Agonist with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D.
Experimental: Part 3 Phase 2 Combination Dose Expansion: TransCon TLR7/8 Agonist with Pembrolizumab - TransCon TLR7/8 Agonist with Pembrolizumab using RP2D from Part 2 to evaluate safety/tolerability and anti-tumor activity of the combination in indication-specific dose expansion cohorts.
Treatment: Drugs: TransCon TLR7/8 Agonist
TransCon TLR7/8 Agonist will be administered as an IT injection
Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered IV
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Tolerability
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Assessment method [1]
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Treatment emergent and treatment related adverse events (assessed by CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths
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Timepoint [1]
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Through study completion, expected average of 2 years
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Primary outcome [2]
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Maximum Tolerated Dose (MTD)
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Assessment method [2]
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Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths.
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Timepoint [2]
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Cycle 1 (each cycle is 21 days) in Part 1 (monotherapy dose escalation) and Cycle 1 (the first cycle is 28 days and 21 days thereafter) in Part 2 (combination therapy dose escalation)
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Primary outcome [3]
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Recommended Phase 2 Dose (RP2D)
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Assessment method [3]
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To determine a recommended phase 2 dose of TransCon TLR7/8 Agonist and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.
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Timepoint [3]
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12 months
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Primary outcome [4]
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Response
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Assessment method [4]
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Evaluate the Pathologic complete response (pCR) per local assessment for pathology review anti-tumor activity of TransCon TLR7/8 Agonist in combination with pembrolizumab in the Neoadjuvant Cohorts
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Timepoint [4]
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9 weeks
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Secondary outcome [1]
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Overall Response Rate
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Assessment method [1]
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Response assessed by RECIST v1.1 and itRECIST (response assessment for intratumoral immunotherapy for injected and noninjected lesions)
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Timepoint [1]
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Average of two years
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Time from first documentation of objective tumor response (CR or PR that is subsequently confirmed) to first documentation of disease progression or death due to any cause, whichever occurs first
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Timepoint [2]
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Average of two years
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Secondary outcome [3]
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Time to Response
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Assessment method [3]
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Time from date of first dose of study treatment to first occurrence of response (CR or PR)
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Timepoint [3]
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Expected up to 1 year from first dose
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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Time from date of first dose of study treatment to first documentation of disease progression or death due to any cause
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Timepoint [4]
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Average of two years
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Secondary outcome [5]
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Event free survival (EFS) by RECIST 1.1 per investigator assessment
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Assessment method [5]
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Timepoint [5]
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Average of two years
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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Time from date of first dose of study treatment to date of death due to any cause
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Timepoint [6]
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Average of two years
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Secondary outcome [7]
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PK characterization - Cmax
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Assessment method [7]
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Maximum observed plasma concentration of resiquimod, O-desethyl resiquimod (metabolite) and total resiquimod (sum of bound and unbound resiquimod) after IT administration of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab
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Timepoint [7]
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Average of two years
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Secondary outcome [8]
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PK characterization - tmax
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Assessment method [8]
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Time to reach maximum plasma concentration of resiquimod, O-desethyl resiquimod (metabolite) and total resiquimod (sum of bound and unbound resiquimod) after IT administration of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab
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Timepoint [8]
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Average of two years
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Secondary outcome [9]
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PK characterization - AUC0-t for first dose only
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Assessment method [9]
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Area under the plasma concentration-time curve from time zero to last sampling time at which the concentration is at or above the lower limit of quantification for resiquimod, O-desethyl resiquimod (metabolite) and total resiquimod (sum of bound and unbound resiquimod) after IT administration of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab
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Timepoint [9]
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Average of two years
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Secondary outcome [10]
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PK characterization - t1/2
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Assessment method [10]
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Apparent terminal half-life of resiquimod, O-desethyl resiquimod (metabolite) and total resiquimod (sum of bound and unbound resiquimod) after IT administration of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab
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Timepoint [10]
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Average of two years
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Secondary outcome [11]
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PK characterization - Ctrough
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Assessment method [11]
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Plasma concentration immediately before next dosing of resiquimod, O-desethyl resiquimod (metabolite) and total resiquimod (sum of bound and unbound resiquimod) after IT administration of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab
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Timepoint [11]
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Average of two years
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Eligibility
Key inclusion criteria
- At least 18 years of age.
- Participants must have histologically confirmed locally advanced, recurrent or
metastatic solid tumor malignancies that cannot be treated with curative intent
(surgery or radiotherapy).
- Participants must have progressed on or be intolerant of available standard of care
treatment options or have disease for which there is no standard of care treatment
available, with the exception of participants enrolling to the neoadjuvant cohorts.
- At least 2 lesions of measurable disease, unless specified otherwise in the selection
criteria.
- Willingness to undergo biopsies.
- Demonstrated adequate organ function within 28 days of Cycle 1 Day 1 (C1D1).
- Life expectancy >12 weeks as determined by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or antiCTLA 4
antibody must have at least 4 weeks from the last dose of antibody and evidence of
disease progression per investigator assessment before enrollment.
- Participants who have previously received an immune checkpoint inhibitor prior to
enrollment must have any immune related toxicities resolved to =Grade 1 or baseline
(prior to the checkpoint inhibitor) to be eligible.
- Female and male participants of childbearing potential who are sexually active must
agree to use highly effective methods of contraception.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants who have been previously treated with a TLR agonist (excluding topical
agents for unrelated disease) are not eligible.
- Other active malignancies within the last 2 years are excluded.
- Active autoimmune diseases, regardless of need for immunosuppressive treatment at the
time of screening, with the exception of patients well controlled on physiologic
endocrine replacement.
- Systemic immunosuppressive treatment with the exception for patients on corticosteroid
taper (for example, for chronic obstructive pulmonary disease exacerbation).
Participants cannot start dosing on study until steroid dose is at or lower than 10 mg
per day prednisone or equivalent.
- Women who are breastfeeding or have a positive serum pregnancy test during screening
or within 72 hours prior to C1D1 are not eligible.
- Vaccination with live, attenuated vaccines within 4 weeks of enrollment.
- Symptomatic central nervous system metastases.
- Known bleeding disorder that is deemed to place the patient at unacceptable risk for
bleeding complications from intratumoral injections or biopsies.
- Known hypersensitivity to any component of TransCon TLR7/8 Agonist or pembrolizumab.
- Any uncontrolled bacterial, fungal, viral, or other infection.
- Treatment with any other anti-cancer systemic treatment (approved or investigational)
or radiation therapy within 4 weeks of first dosing on study is not allowed.
- Significant cardiac disease
- A marked baseline prolongation of QT/QTc (corrected QT) interval (e.g., repeated
demonstration of a QTc interval >480 ms (National Cancer Institute NCI) Common
Terminology Criteria for Adverse Events [CTCAE] grade 1) using Fredericia's QT
correction formula.
- A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart
failure, clinically significant hypokalemia, family history of Long QT Syndrome).
- The use of concomitant medications that prolong the QT/QTc interval within 14 days of
enrollment.
- Positive for HIV or with active hepatitis B or C infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2026
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Ascendis Pharma Investigational Site - Wollongong
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Recruitment hospital [2]
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Ascendis Pharma Investigational Site - Clayton
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Recruitment hospital [3]
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Ascendis Pharma Investigational Site - Frankston
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Recruitment hospital [4]
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Ascendis Investigational Site - Bedford Park
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3199 - Frankston
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Recruitment postcode(s) [4]
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5042 - Bedford Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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State/province [4]
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Iowa
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Country [5]
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United States of America
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State/province [5]
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Kentucky
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Pennsylvania
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Country [8]
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United States of America
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State/province [8]
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Tennessee
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United States of America
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State/province [9]
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Texas
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United States of America
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Virginia
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Korea, Republic of
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Dalseo-gu
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Korea, Republic of
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State/province [12]
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Seocho-gu
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Korea, Republic of
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State/province [13]
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Seogu
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Korea, Republic of
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State/province [14]
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Seongnam
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Korea, Republic of
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Seoul
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Korea, Republic of
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State/province [16]
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Suwon-si
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Málaga
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Spain
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Pamplona
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Tainan
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Country [27]
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Taiwan
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State/province [27]
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Taipei City
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Ascendis Pharma Oncology Division A/S
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
TransCon TLR7/8 Agonist is an investigational drug being developed for treatment of locally
advanced or metastatic solid tumors. This Phase 1/2 study will evaluate TransCon TLR7/8
Agonist as monotherapy or in combination with pembrolizumab in dose escalation and dose
expansion. Participants will receive intratumoral (IT) injection of TransCon TLR7/8 Agonist
every cycle. The primary objectives are to evaluate safety and tolerability, and define the
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TransCon TLR7/8 Agonist
alone or in combination with pembrolizumab.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04799054
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Joan Morris
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Address
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Medical Monitor
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Janet Connolly-Giwa
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Address
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Phone
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+1 650-512-2153
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04799054
Download to PDF