A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ 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
Active, not recruiting · Phase 1, Phase 2 · NCT05081609
Conditions: 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, Post Anti-PD-(L)1 Non-Small Cell Lung Cancer, Post Anti-PD-(L)1 Small Cell Lung Cancer, Third Line or Later (3L+) HER2+ Breast Cancer, Second or Third Line (2L/3L) Cervical Cancer, Third-line or Later (3L+) Platinum-resistant Ovarian Cancer (PROC)
At a glance
- Research payments reported, 2025
- $465,478
- U.S. investigators named
- 11
- Sites paid
- 11
- Planned or actual enrollment
- 320
About the trial
- Sponsor
- Ascendis Pharma Oncology Division A/S
- Tested
- TransCon IL-2 β/γ (drug), Pembrolizumab (drug), Chemotherapy drug (drug), TransCon TLR7/8 Agonist (drug), Surgery (procedure), Trastuzumab (drug), Trastuzumab emtansine (T-DM1) (drug)
- Dates
- Started 2022-01-11; completion 2029-08
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-10-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Ascendis Pharma Endocrinology Inc reported $465,478 in research payments for this study in 2025 (66 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Krishna A. Rao, M.D. Hematology & Oncology · Springfield, IL
- Jaspreet S. Grewal, M.D., M.P.H. Hematology & Oncology · Louisville, KY
- Oladapo O. Yeku, M.D, PHD Hematology & Oncology · Boston, MA
- Eric Whitman, MD General Surgery · Morristown, NJ
- June Y. Hou, M.D. Gynecologic Oncology · Bronx, NY
- Nashat Gabrail, M.D. Specialist · Canton, OH
- Debra L. Richardson, M.D. Gynecologic Oncology · Oklahoma City, OK
- Diwakar Davar Hematology & Oncology · Pittsburgh, PA
- David R. Spigel, M.D. Medical Oncology · Nashville, TN
- Andrew Poklepovic, M.D. Internal Medicine · Richmond, VA
- Bobbie J. Rimel, MD Gynecologic Oncology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- University of Pittsburgh $176,782
- The Carl and Edyth Lindner Center $86,248
- Norton Healthcare, Inc. $42,087
- Dana-Farber/mass General Brigham Cancer Care, Inc. $38,184
- Sarah Cannon Research Institute, LLC $35,030
- Board of Trustees of Southern Illinois University $26,175
- Virginia Commonwealth University $19,733
- Cedars-Sinai Medical Center, CA $19,568
- Morristown Medical Center, NJ $9,875
- The Trustees of Columbia University in The City of New York $8,373
- Gabrail Cancer Center Research LLC $3,422
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.