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A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or Chemotherapy or TransCon TLR7/8 Agonist in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (IL Believe)

Primary Purpose

Advanced Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TransCon IL-2 β/γ
Pembrolizumab
Chemotherapy drug
TransCon TLR7/8 Agonist
Surgery
Sponsored by
Ascendis Pharma Oncology Division A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • At least 18 years of age
  • Demonstrated adequate organ function at screening
  • Life expectancy >12 weeks as determined by the Investigator
  • At least 1 lesion of measurable disease, except for Post Anti-PD-1 Melanoma and 2L+ Cervical Cancer (at least 2 lesions of measurable disease)
  • 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: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Part 1 and Part 2: Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-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)
  • Part 1 and Part 2: 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: Part 3, neoadjuvant cohorts: participants must have completely resectable disease

Key Exclusion Criteria:

  • Symptomatic central nervous system metastases
  • 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 HIV or has known active hepatitis B or C infection
  • Known hypersensitivity to any study treatment(s) used in the specific study part/cohort
  • Participants who have been previously treated with IL-2 or IL-2 variants (all participants), or TLR agonist (Part 3 only for Post Anti-PD-1 Melanoma, 2L+ Cervical Cancer, and Neoadjuvant Melanoma)
  • 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

Sites / Locations

  • Ascendis Pharma Investigational SiteRecruiting
  • Ascendis Pharma Investigational SiteRecruiting
  • Ascendis Pharma Investigational SiteRecruiting
  • Ascendis Pharma Investigational SiteRecruiting
  • Ascendis Pharma Investigational SiteRecruiting
  • Ascendis Pharma Investigational SiteRecruiting
  • Ascendis Pharma Investigational SiteRecruiting
  • Ascendis Pharma Investigational SiteRecruiting
  • Ascendis Pharma Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ

Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab

Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo

Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 Agonist

Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgery

Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgery

Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgery

Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgery

Arm Description

TransCon IL-2 β/γ in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D

TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D

TransCon IL-2 β/γ using the RP2D with SOC Chemotherapy to evaluate safety/tolerability and anti-tumor activity of the combination

TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D to evaluate safety/tolerability and anti-tumor activity of the combination

TransCon IL-2 β/γ using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

TransCon IL-2 β/γ using the RP2D with Pembrolizumab followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

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

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

Outcomes

Primary Outcome Measures

Safety and Tolerability
Treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths.
Maximum Tolerated Dose (MTD)
Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths.
Recommended Phase 2 Dose (RP2D)
To determine a recommended phase 2 dose of TransCon IL-2 β/γ and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.

Secondary Outcome Measures

Overall Response Rate
Response assessed by RECIST v1.1
Pathologic Complete Response
Evaluate the pathologic Complete Response (pCR) for anti-tumor activity of TransCon IL-2 β/γ alone or in combination with pembrolizumab, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy in the Neoadjuvant Cohorts
Major Pathologic Response
Evaluate the Major Pathologic Response (MPR) for anti-tumor activity of TransCon IL-2 β/γ alone or in combination with pembrolizumab, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy in the Neoadjuvant Cohorts
Duration of Response
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
Time to Response
Time from date of first dose of study treatment to first occurrence of response (CR or PR)
Progression Free Survival (PFS)
Time from date of first dose of study treatment to first documentation of disease progression or death due to any cause
Event free survival (EFS) by RECIST 1.1
Time from the date of the first dose of study treatment to the occurrence of any of the following: progression of disease that precludes surgery, disease recurrence after surgery, or death from any cause.
Overall Survival (OS)
Time from date of first dose of study treatment to date of death due to any cause
PK Characterization (Cmax)
Maximum observed plasma concentration of TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
PK Characterization (Tmax)
Time to reach maximum plasma concentration of TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination other therapies
PK Characterization (AUClast)
Area under the plasma concentration curve from time zero to last sampling time at which the concentration is at or above the lower limit of quantification for TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
PK Characterization (AUC0-t)
Area under the plasma concentration curve from time zero to time t for TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
PK Characterization (t1/2)
Apparent terminal half-life of TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies

Full Information

First Posted
October 5, 2021
Last Updated
April 14, 2023
Sponsor
Ascendis Pharma Oncology Division A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05081609
Brief Title
A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or Chemotherapy or TransCon TLR7/8 Agonist in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Acronym
IL Believe
Official 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 β/γ Alone or in Combination With Pembrolizumab, Standard of Care Chemotherapy, or TransCon TLR7/8 Agonist, or in Combination With Pembrolizumab and Standard of Care Chemotherapy, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascendis Pharma Oncology Division A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
IL-2 is a key cytokine that directs the immune system through pleiotropic effects mediated by promoting expansion of both cytotoxic effector cells and Tregs. TransCon IL-2 β/γ is designed as a long-acting delivery prodrug of IL-2 β/γ, a potent cytokine signaling molecule, with the potential to improve the safety and efficacy of IL-2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor, Platinum-resistant Ovarian Cancer, Post Anti-PD-1 Melanoma, 2L+ Cervical Cancer, Neoadjuvant Melanoma, Neoadjuvant Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
317 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ
Arm Type
Experimental
Arm Description
TransCon IL-2 β/γ in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D
Arm Title
Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab
Arm Type
Experimental
Arm Description
TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D
Arm Title
Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo
Arm Type
Experimental
Arm Description
TransCon IL-2 β/γ using the RP2D with SOC Chemotherapy to evaluate safety/tolerability and anti-tumor activity of the combination
Arm Title
Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 Agonist
Arm Type
Experimental
Arm Description
TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D to evaluate safety/tolerability and anti-tumor activity of the combination
Arm Title
Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgery
Arm Type
Experimental
Arm Description
TransCon IL-2 β/γ using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination
Arm Title
Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgery
Arm Type
Experimental
Arm Description
TransCon IL-2 β/γ using the RP2D with Pembrolizumab followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination
Arm Title
Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgery
Arm Type
Experimental
Arm Description
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
Arm Title
Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgery
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
TransCon IL-2 β/γ
Intervention Description
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab will be administered as an intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Chemotherapy drug
Intervention Description
SOC chemotherapy will be administered as an intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
TransCon TLR7/8 Agonist
Intervention Description
TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery will take place 4-6 weeks after last dose of study treatment.
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
Treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths.
Time Frame
Through study completion, expected average of 2 years
Title
Maximum Tolerated Dose (MTD)
Description
Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths.
Time Frame
Each cycle is 21 days
Title
Recommended Phase 2 Dose (RP2D)
Description
To determine a recommended phase 2 dose of TransCon IL-2 β/γ and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
Response assessed by RECIST v1.1
Time Frame
Average of 2 years
Title
Pathologic Complete Response
Description
Evaluate the pathologic Complete Response (pCR) for anti-tumor activity of TransCon IL-2 β/γ alone or in combination with pembrolizumab, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy in the Neoadjuvant Cohorts
Time Frame
15 weeks
Title
Major Pathologic Response
Description
Evaluate the Major Pathologic Response (MPR) for anti-tumor activity of TransCon IL-2 β/γ alone or in combination with pembrolizumab, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy in the Neoadjuvant Cohorts
Time Frame
15 weeks
Title
Duration of Response
Description
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
Time Frame
Average of 2 years
Title
Time to Response
Description
Time from date of first dose of study treatment to first occurrence of response (CR or PR)
Time Frame
Expected up to 1 year from first dose
Title
Progression Free Survival (PFS)
Description
Time from date of first dose of study treatment to first documentation of disease progression or death due to any cause
Time Frame
Average of 2 years
Title
Event free survival (EFS) by RECIST 1.1
Description
Time from the date of the first dose of study treatment to the occurrence of any of the following: progression of disease that precludes surgery, disease recurrence after surgery, or death from any cause.
Time Frame
2 years
Title
Overall Survival (OS)
Description
Time from date of first dose of study treatment to date of death due to any cause
Time Frame
Average of 2 years
Title
PK Characterization (Cmax)
Description
Maximum observed plasma concentration of TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
Time Frame
Average of 2 years
Title
PK Characterization (Tmax)
Description
Time to reach maximum plasma concentration of TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination other therapies
Time Frame
Average of 2 years
Title
PK Characterization (AUClast)
Description
Area under the plasma concentration curve from time zero to last sampling time at which the concentration is at or above the lower limit of quantification for TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
Time Frame
Average of 2 years
Title
PK Characterization (AUC0-t)
Description
Area under the plasma concentration curve from time zero to time t for TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
Time Frame
Average of 2 years
Title
PK Characterization (t1/2)
Description
Apparent terminal half-life of TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
Time Frame
Average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: At least 18 years of age Demonstrated adequate organ function at screening Life expectancy >12 weeks as determined by the Investigator At least 1 lesion of measurable disease, except for Post Anti-PD-1 Melanoma and 2L+ Cervical Cancer (at least 2 lesions of measurable disease) 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: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Part 1 and Part 2: Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-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) Part 1 and Part 2: 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: Part 3, neoadjuvant cohorts: participants must have completely resectable disease Key Exclusion Criteria: Symptomatic central nervous system metastases 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 HIV or has known active hepatitis B or C infection Known hypersensitivity to any study treatment(s) used in the specific study part/cohort Participants who have been previously treated with IL-2 or IL-2 variants (all participants), or TLR agonist (Part 3 only for Post Anti-PD-1 Melanoma, 2L+ Cervical Cancer, and Neoadjuvant Melanoma) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ray Tam
Phone
650-374-9144
Email
RTM@ascendispharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davis Torrejon-Castro
Organizational Affiliation
Ascendis Pharma Oncology Division A/S
Official's Role
Study Director
Facility Information:
Facility Name
Ascendis Pharma Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascendis Pharma Investigational Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascendis Pharma Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascendis Pharma Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascendis Pharma Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascendis Pharma Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascendis Pharma Investigational Site
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Name
Ascendis Pharma Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Ascendis Pharma Investigational Site
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35817480
Citation
Rosen DB, Kvarnhammar AM, Laufer B, Knappe T, Karlsson JJ, Hong E, Lee YC, Thakar D, Zuniga LA, Bang K, Sabharwal SS, Uppal K, Olling JD, Kjaergaard K, Kurpiers T, Schnabel M, Reich D, Glock P, Zettler J, Krusch M, Bernhard A, Heinig S, Konjik V, Wegge T, Hehn Y, Killian S, Viet L, Runz J, Faltinger F, Tabrizi M, Abel KL, Breinholt VM, Singel SM, Sprogoe K, Punnonen J. TransCon IL-2 beta/gamma: a novel long-acting prodrug with sustained release of an IL-2Rbeta/gamma-selective IL-2 variant with improved pharmacokinetics and potent activation of cytotoxic immune cells for the treatment of cancer. J Immunother Cancer. 2022 Jul;10(7):e004991. doi: 10.1136/jitc-2022-004991.
Results Reference
derived

Learn more about this trial

A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or Chemotherapy or TransCon TLR7/8 Agonist in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

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