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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04799054




Registration number
NCT04799054
Ethics application status
Date submitted
26/02/2021
Date registered
16/03/2021

Titles & IDs
Public title
A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors
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
Secondary ID [1] 0 0
transcendIT-101
Secondary ID [2] 0 0
TCTLR-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Locally Advanced Solid Tumor 0 0
Metastatic Solid Tumor 0 0
Head and Neck Squamous Cell Carcinoma HNSCC 0 0
HPV-associated Cancers 0 0
Neoadjuvant Melanoma 0 0
Neoadjuvant Cutaneous Squamous Cell Carcinoma (cSCC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability
Timepoint [1] 0 0
Through study completion, expected average of 2 years
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [2] 0 0
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)
Primary outcome [3] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Response
Timepoint [4] 0 0
9 weeks
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Average of two years
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
Average of two years
Secondary outcome [3] 0 0
Time to Response
Timepoint [3] 0 0
Expected up to 1 year from first dose
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
Average of two years
Secondary outcome [5] 0 0
Event free survival (EFS) by RECIST 1.1 per investigator assessment
Timepoint [5] 0 0
Average of two years
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Average of two years
Secondary outcome [7] 0 0
PK characterization - Cmax
Timepoint [7] 0 0
Average of two years
Secondary outcome [8] 0 0
PK characterization - tmax
Timepoint [8] 0 0
Average of two years
Secondary outcome [9] 0 0
PK characterization - AUC0-t for first dose only
Timepoint [9] 0 0
Average of two years
Secondary outcome [10] 0 0
PK characterization - t1/2
Timepoint [10] 0 0
Average of two years
Secondary outcome [11] 0 0
PK characterization - Ctrough
Timepoint [11] 0 0
Average of two years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Ascendis Pharma Investigational Site - Wollongong
Recruitment hospital [2] 0 0
Ascendis Pharma Investigational Site - Frankston
Recruitment hospital [3] 0 0
Ascendis Investigational Site - Bedford Park
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Dalseo-gu
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seocho-gu
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seogu
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seongnam
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Suwon-si
Country [17] 0 0
Netherlands
State/province [17] 0 0
Amsterdam
Country [18] 0 0
Netherlands
State/province [18] 0 0
Rotterdam
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Murcia
Country [22] 0 0
Spain
State/province [22] 0 0
Málaga
Country [23] 0 0
Spain
State/province [23] 0 0
Pamplona
Country [24] 0 0
Spain
State/province [24] 0 0
Sevilla
Country [25] 0 0
Spain
State/province [25] 0 0
Valencia
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taichung
Country [27] 0 0
Taiwan
State/province [27] 0 0
Tainan
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ascendis Pharma Oncology Division A/S
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Joan Morris
Address 0 0
Medical Monitor
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ascendis Oncology Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
+1 650-352-8389
Fax 0 0
Email 0 0
OncologyClinicalTrials@ascendispharma.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/NCT04799054