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

Trial 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.

 

Receptor status / problem studied:

Inclusion criteria

  • 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

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

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Open for recruitment

Trial Title

IL Believe

Diagnosis

Advanced solid tumours Cervical cancer Lung cancer Skin cancer – melanoma

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

I/II

Locations

Investigators

Principal Investigator
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