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

Launched by ASCENDIS PHARMA ONCOLOGY DIVISION A/S · Oct 5, 2021

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called TransCon IL-2 β/γ, which is being studied for adults with advanced solid tumors that cannot be treated with surgery or radiation. The trial is looking to see how safe this drug is, how well it can be tolerated, and whether it works better when combined with other cancer treatments like pembrolizumab. It is currently recruiting participants aged 18 and older who have specific types of cancer, and who are in relatively good health, meaning their organs are functioning well and they have a life expectancy of more than 12 weeks.

Participants in this trial can expect to receive either the new drug alone or in combination with other therapies, depending on their specific situation. Before joining, they will need to meet certain criteria, such as having a confirmed diagnosis of an advanced tumor, and they must have recovered from any previous cancer treatments. While participating, they will be monitored closely for any side effects or changes in their health. It's important to note that individuals with certain medical conditions or those who have had specific prior treatments may not be eligible to participate. This study is part of the early stages of research, which means it's a first step in understanding how well this new treatment works for patients.

Gender

ALL

Eligibility criteria

• 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