Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 2L+ Cervical Cancer | — | UNRESOLVED | — |
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Locally Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Neoadjuvant Melanoma | — | UNRESOLVED | — |
| Neoadjuvant Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
| Platinum-resistant Ovarian Cancer | Platinum-Resistant Ovarian Carcinoma | ALIAS | 0.90 |
| Post Anti-PD-1 Melanoma | — | UNRESOLVED |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy drug | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
| TransCon IL-2 β/γ | Drug | — | UNRESOLVED |
| TransCon TLR7/8 Agonist | Drug | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
| Trastuzumab emtansine (T-DM1) | Drug | Trastuzumab Emtansine | ALIAS |
Design
Arms and outcomes
Arms (13)
- type
- EXPERIMENTAL
- label
- Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ
- description
- TransCon IL-2 β/γ in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D
- interventionNames
- Drug: TransCon IL-2 β/γ
- type
- EXPERIMENTAL
- label
- Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab
- description
- TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D
- interventionNames
- Drug: TransCon IL-2 β/γ
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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 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 * Participants who have been previously treated with IL-2 or IL-2 variants (all participants) * 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
References
Publications (1)
- DERIVEDRosen 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. PMID 35817480