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IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ 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

Status: Active_not_recruiting
Location: See all (68) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2 β/γ as monotherapy or in combination therapy in adult participants with advanced or metastatic solid tumors. Given the unique PK profile enabled by the TransCon technology, TransCon IL-2 β/γ presents the opportunity to enhance the therapeutic index of current IL-2 therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
California
Ascendis Pharma Investigational Site
Los Angeles
Ascendis Pharma Investigational Site
Los Angeles
Illinois
Ascendis Pharma Investigational Site
Springfield
Kentucky
Ascendis Pharma Investigational Site
Louisville
Massachusetts
Ascendis Pharma Investigational Site
Boston
North Carolina
Ascendis Pharma Investigational Site
Huntersville
New Jersey
Ascendis Pharma Investigational Site
Morristown
New York
Ascendis Pharma Investigational Site
New York
Ohio
Ascendis Pharma Investigational Site
Canton
Ascendis Pharma Investigational Site
Cincinnati
Oklahoma
Ascendis Pharma Investigational Site
Oklahoma City
Pennsylvania
Ascendis Pharma Investigational Site
Pittsburgh
Tennessee
Ascendis Pharma Investigational Site
Nashville
Virginia
Ascendis Pharma Investigational Site
Richmond
Other Locations
Australia
Ascendis Pharma Investigational Site
Adelaide
Ascendis Pharma Investigational Site
Adelaide
Ascendis Pharma Investigational Site
Brisbane
Ascendis Pharma Investigational Site
Frankston
Ascendis Pharma Investigational Site
Southport
Ascendis Pharma Investigational Site
Toorak Gardens
Ascendis Pharma Investigational Site
Waratah
Belgium
Ascendis Pharma Investigational Site
Wilrijk
Canada
Ascendis Pharma Investigational Site
Montreal
Ascendis Pharma Investigational Site
Toronto
Ascendis Pharma Investigational Site
Toronto
Italy
Ascendis Pharma Investigational Site
Cuneo
Ascendis Pharma Investigational Site
Florence
Ascendis Pharma Investigational Site
Grosseto
Ascendis Pharma Investigational Site
Lido Di Camaiore
Ascendis Pharma Investigational Site
Livorno
Ascendis Pharma Investigational Site
Meldola
Ascendis Pharma Investigational Site
Milan
Ascendis Pharma Investigational Site
Milan
Ascendis Pharma Investigational Site
Modena
Ascendis Pharma Investigational Site
Roma
Ascendis Pharma Investigational Site
Torino
Ascendis Pharma Investigational Site
Turin
Ascendis Pharma Investigational Site
Verona
Poland
Ascendis Pharma Investigational Site
Krakow
Ascendis Pharma Investigational Site
Poznan
Ascendis Pharma Investigational Site
Warsaw
Republic of Korea
Ascendis Pharma Investigational Site
Seongnam-si
Ascendis Pharma Investigational Site
Seoul
Ascendis Pharma Investigational Site
Seoul
Ascendis Pharma Investigational Site
Seoul
Ascendis Pharma Investigational Site
Seoul
Ascendis Pharma Investigational Site
Seoul
Singapore
Ascendis Pharma Investigational Site
Singapore
Ascendis Pharma Investigational Site
Singapore
Spain
Ascendis Pharma Investigational Site
Barcelona
Ascendis Pharma Investigational Site
Barcelona
Ascendis Pharma Investigational Site
Barcelona
Ascendis Pharma Investigational Site
L'hospitalet De Llobregat
Ascendis Pharma Investigational Site
Madrid
Ascendis Pharma Investigational Site
Madrid
Ascendis Pharma Investigational Site
Madrid
Ascendis Pharma Investigational Site
Madrid
Ascendis Pharma Investigational Site
Madrid
Ascendis Pharma Investigational Site
Málaga
Ascendis Pharma Investigational Site
Murcia
Ascendis Pharma Investigational Site
Oviedo
Ascendis Pharma Investigational Site
Pamplona
Ascendis Pharma Investigational Site
Seville
Ascendis Pharma Investigational Site
Seville
Ascendis Pharma Investigational Site
Valencia
Ascendis Pharma Investigational Site
Valencia
Taiwan
Ascendis Pharma Investigational Site
Taipei
Ascendis Pharma Investigational Site
Taipei
Time Frame
Start Date: 2022-01-11
Completion Date: 2029-08
Participants
Target number of participants: 320
Treatments
Experimental: Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ
TransCon IL-2 β/γ in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D
Experimental: Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab
TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo
TransCon IL-2 β/γ 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 β/γ with TransCon TLR7/8 Agonist
TransCon IL-2 β/γ 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 β/γ followed by surgery
(Optional Arm): TransCon IL-2 β/γ 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 β/γ with Pembrolizumab followed by surgery
TransCon IL-2 β/γ 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 β/γ with TransCon TLR7/8 Agonist followed by surgery
TransCon IL-2 β/γ 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 β/γ + Pembrolizumab + SOC Chemo followed by surgery
TransCon IL-2 β/γ 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 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D with Pembrolizumab
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ monotherapy
TransCon IL-2 β/γ monotherapy
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab
TransCon IL-2 β/γ + trastuzumab
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1)
TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1)
Experimental: Part 4 Combination Dose Optimization
TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D in titrating doses and/or different dose frequencies with Pembrolizumab
Sponsors
Leads: Ascendis Pharma Oncology Division A/S

This content was sourced from clinicaltrials.gov

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