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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05081609




Registration number
NCT05081609
Ethics application status
Date submitted
5/10/2021
Date registered
18/10/2021

Titles & IDs
Public title
A Study to Investigate Safety and Tolerability of TransCon IL-2 ß/? Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Scientific title
IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 ß/? Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Secondary ID [1] 0 0
ASND0029
Universal Trial Number (UTN)
Trial acronym
IL Believe
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
Platinum-resistant Ovarian Cancer 0 0
Post Anti-PD-1 Melanoma 0 0
2L+ Cervical Cancer 0 0
Neoadjuvant Melanoma 0 0
Neoadjuvant Non-Small Cell Lung Cancer 0 0
Post Anti-PD-(L)1 Non-Small Cell Lung Cancer 0 0
Post Anti-PD-(L)1 Small Cell Lung Cancer 0 0
Third Line or Later (3L+) HER2+ Breast Cancer 0 0
Second or Third Line (2L/3L) Cervical Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TransCon IL-2 ß/?
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Chemotherapy drug
Treatment: Drugs - TransCon TLR7/8 Agonist
Treatment: Surgery - Surgery
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Trastuzumab emtansine (T-DM1)

Experimental: Part 1 Monotherapy Dose Escalation: TransCon IL-2 ß/? - TransCon IL-2 ß/? in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D

Experimental: Part 2 Combination Dose Escalation: TransCon IL-2 ß/? with Pembrolizumab - TransCon IL-2 ß/? with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D

Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 ß/? with SOC Chemo - TransCon IL-2 ß/? using the RP2D with SOC Chemotherapy to evaluate safety/tolerability and anti-tumor activity of the combination

Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 ß/? with TransCon TLR7/8 Agonist - TransCon IL-2 ß/? with TransCon TLR7/8 Agonist using the RP2D to evaluate safety/tolerability and anti-tumor activity of the combination

Experimental: Part 3 Monotherapy Dose Expansion: TransCon IL-2 ß/? followed by surgery - (Optional Arm): TransCon IL-2 ß/? using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 ß/? with Pembrolizumab followed by surgery - TransCon IL-2 ß/? using the RP2D with Pembrolizumab followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Experimental: Part 3 Combination Dose Expansion:TransCon IL-2 ß/? with TransCon TLR7/8 Agonist followed by surgery - TransCon IL-2 ß/? with TransCon TLR7/8 Agonist using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Experimental: Part 3 Combination Dose Expansion:TransCon IL-2 ß/? + Pembrolizumab + SOC Chemo followed by surgery - TransCon IL-2 ß/? using the RP2D with Pembrolizumab and SOC Chemotherapy followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Experimental: Part 3 Combination Dose Expansion - TransCon IL-2 ß/? + Pembrolizumab TransCon IL-2 ß/? using the RP2D with Pembrolizumab

Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 ß/? monotherapy - TransCon IL-2 ß/? monotherapy

Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 ß/? + trastuzumab - TransCon IL-2 ß/? + trastuzumab

Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 ß/? + trastuzumab emtansine (T-DM1) - TransCon IL-2 ß/? + trastuzumab emtansine (T-DM1)

Experimental: Part 4 Combination Dose Optimization - TransCon IL-2 ß/? + Pembrolizumab TransCon IL-2 ß/? using the RP2D in titrating doses and/or different dose frequencies with Pembrolizumab


Treatment: Drugs: TransCon IL-2 ß/?
TransCon IL-2 ß/? will be administered as an intravenous (IV) infusion

Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion

Treatment: Drugs: Chemotherapy drug
SOC chemotherapy will be administered as an intravenous (IV) infusion

Treatment: Drugs: TransCon TLR7/8 Agonist
TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection

Treatment: Surgery: Surgery
Surgery will take place 4-6 weeks after last dose of study treatment.

Treatment: Drugs: Trastuzumab
Trastuzumab will be administered as an intravenous (IV) infusion

Treatment: Drugs: Trastuzumab emtansine (T-DM1)
Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
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
Each cycle is 21 days
Primary outcome [3] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Average of 2 years
Secondary outcome [2] 0 0
Pathologic Complete Response
Timepoint [2] 0 0
15 weeks
Secondary outcome [3] 0 0
Major Pathologic Response
Timepoint [3] 0 0
15 weeks
Secondary outcome [4] 0 0
Duration of Response
Timepoint [4] 0 0
Average of 2 years
Secondary outcome [5] 0 0
Time to Response
Timepoint [5] 0 0
Expected up to 1 year from first dose
Secondary outcome [6] 0 0
Progression Free Survival (PFS)
Timepoint [6] 0 0
Average of 2 years
Secondary outcome [7] 0 0
Event free survival (EFS) by RECIST 1.1
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
Average of 2 years
Secondary outcome [9] 0 0
PK Characterization (Cmax)
Timepoint [9] 0 0
Average of 2 years
Secondary outcome [10] 0 0
PK Characterization (Tmax)
Timepoint [10] 0 0
Average of 2 years
Secondary outcome [11] 0 0
PK Characterization (AUClast)
Timepoint [11] 0 0
Average of 2 years
Secondary outcome [12] 0 0
PK Characterization (AUC0-t)
Timepoint [12] 0 0
Average of 2 years
Secondary outcome [13] 0 0
PK Characterization (t1/2)
Timepoint [13] 0 0
Average of 2 years

Eligibility
Key inclusion criteria
Key

* At least 18 years of age, or country defined local legal age
* Demonstrated adequate organ function at screening
* Life expectancy >12 weeks as determined by the Investigator
* Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception
* Participants must have histologically confirmed locally advanced, recurrent, or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of the neoadjuvant cohorts
* Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Part 3 and Part 4: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) antibody must have a washout of at least 4 weeks from the last dose and evidence of disease progression per investigator assessment before Cycle 1 Day 1 (C1D1) with the exception of the neoadjuvant cohorts
* Participants who have previously received an immunotherapy prior to C1D1 must have any immune-related toxicities resolved to =Grade 1 or baseline (prior to the immunotherapy) to be eligible, with the exception of participants on well controlled physiologic endocrine replacement
* Part 3: Neoadjuvant cohorts: participants must have completely resectable disease

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Symptomatic central nervous system metastases and/or carcinomatous meningitis
* Active autoimmune diseases, regardless of need for immunosuppressive treatment, with the exception of participants well controlled on physiologic endocrine replacement
* Any uncontrolled bacterial, fungal, viral, or other infection
* Significant cardiac disease
* A marked clinically significant baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 ms) [CTCAE Grade 1]) using Fridericia's QT correction formula
* Positive for human immunodeficiency virus (HIV) or has known active hepatitis B or C infection
* Known hypersensitivity to any study treatment(s) used in the specific study part/cohort
* Part 3, Post Anti-PD-1 Melanoma, 2L+ Cervical Cancer, and Neoadjuvant Melanoma: Participants who have been previously treated with IL-2 or IL-2 variants (all participants), or TLR agonist
* Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation).
* Vaccination with live, attenuated vaccines within 4 weeks of C1D1
* Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of C1D1
* Part 3: Other active malignancies within the last 2 years
* Women who are breastfeeding or have a positive serum pregnancy test during screening

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2029
Actual
Sample size
Target
473
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ascendis Pharma Investigational Site - Adelaide
Recruitment hospital [2] 0 0
Ascendis Pharma Investigational Site - Frankston
Recruitment hospital [3] 0 0
Ascendis Pharma Investigational Site - Southport
Recruitment hospital [4] 0 0
Ascendis Pharma Investigational Site - Toorak Gardens
Recruitment hospital [5] 0 0
Ascendis Pharma Investigational Site - Waratah
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
05065 - Toorak Gardens
Recruitment postcode(s) [6] 0 0
2298 - Waratah
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
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
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
Virginia
Country [10] 0 0
Belgium
State/province [10] 0 0
Wilrijk
Country [11] 0 0
Canada
State/province [11] 0 0
Montréal
Country [12] 0 0
Canada
State/province [12] 0 0
Toronto
Country [13] 0 0
Italy
State/province [13] 0 0
Firenze
Country [14] 0 0
Italy
State/province [14] 0 0
Grosseto
Country [15] 0 0
Italy
State/province [15] 0 0
Lido Di Camaiore
Country [16] 0 0
Italy
State/province [16] 0 0
Livorno
Country [17] 0 0
Italy
State/province [17] 0 0
Meldola
Country [18] 0 0
Italy
State/province [18] 0 0
Milan
Country [19] 0 0
Italy
State/province [19] 0 0
Roma
Country [20] 0 0
Italy
State/province [20] 0 0
Turin
Country [21] 0 0
Italy
State/province [21] 0 0
Verona
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Songpa-gu
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seongnam-si
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
Poland
State/province [25] 0 0
Kraków
Country [26] 0 0
Poland
State/province [26] 0 0
Poznan
Country [27] 0 0
Poland
State/province [27] 0 0
Warszawa
Country [28] 0 0
Singapore
State/province [28] 0 0
Singapore
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Murcia
Country [32] 0 0
Spain
State/province [32] 0 0
Málaga
Country [33] 0 0
Spain
State/province [33] 0 0
Oviedo
Country [34] 0 0
Spain
State/province [34] 0 0
Pamplona
Country [35] 0 0
Spain
State/province [35] 0 0
Sevilla
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei

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
Davis Torrejon-Castro
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/NCT05081609