Trial details

Trial short name: IL Believe

Official 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 (IL Believe)

Principal Investigator: Dr. Rossanna Pezo

Cancer type: Melanoma
Cancer location: Melanoma
Disease stage: Early Cancer
Trial phase: Phase 1, Phase 2
Intervention: Drug: TransCon IL-2 β/γ, Pembrolizumab, Chemotherapy drug, TransCon TLR7/8 Agonist, Procedure: Surgery

Registration #: NCT05081609

Contact e-mail: cancerclinicaltrials@sunnybrook.ca

Trial 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.

Key Inclusion Criteria: • At least 18 years of 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 • 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