TransCon IL-2 β/γ in Locally Advanced or Metastatic Solid Tumor Malignancies

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called TransCon IL-2 beta/gamma when given in combination with chemotherapy or in combination with another experimental drug, TransCon TLR7/8 Agonist, for the treatment of advanced cancer. Specifically, researchers aim to determine whether the addition of TransCon IL-2 beta/gamma or TransCon TLR7/8 Agonist leads to better outcomes for patients with platinum-resistant ovarian cancer or recurrent/metastatic (cancer that has spread to other parts of the body) cervical cancer. Researchers will also examine the effect of the drugs on the patient's cancer by conducting biomarker studies. Biomarkers are important biological indicators that can be measured from blood and tumor tissues.

Eligibility

* 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

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

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Where can I participate?

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

What is the full name of this clinical trial?

ASND0029 IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 beta/gamma Alone or in Combination with Pembrolizumab or Standard of Care Chemotherapy in Participants Aged 18 Years or Older with Locally Advanced or Metastatic Solid Tumor Malignancies

Study Details

Disease Type/Condition

Ovary

Principal Investigator

Rimel, Bobbie Jo

Co-Investigators

Andrew Li, Kamya Sankar, Kenneth Kim, Kristin Taylor, Margaret Liang

Age Group

Adult

Phase

I/II

IRB Number

STUDY00002814

ClinicalTrials.gov ID

NCT05081609

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org