Condition

Neoadjuvant Melanoma

Purpose of the study

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. NCT05081609   

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, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies. 

Who is eligible to participate?

• 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 

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane