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

Description

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.

Conditions

Advanced Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor, Platinum-resistant Ovarian Cancer, Post Anti-PD-1 Melanoma, 2L+ Cervical Cancer, Neoadjuvant Melanoma, Neoadjuvant Non-Small Cell Lung Cancer, Post Anti-PD-(L)1 Non-Small Cell Lung Cancer, Post Anti-PD-(L)1 Small Cell Lung Cancer, Third Line or Later (3L+) HER2+ Breast Cancer, Second or Third Line (2L/3L) Cervical Cancer

Study Overview

Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Ascendis Pharma Investigational Site, Los Angeles, California, United States, 90048

Los Angeles

Ascendis Pharma Investigational Site, Los Angeles, California, United States, 90067

Boston

Ascendis Pharma Investigational Site, Boston, Massachusetts, United States, 02114

New York

Ascendis Pharma Investigational Site, New York, New York, United States, 10032

Huntersville

Ascendis Pharma Investigational Site, Huntersville, North Carolina, United States, 28078

Canton

Ascendis Pharma Investigational Site, Canton, Ohio, United States, 44718

Cincinnati

Ascendis Pharma Investigational Site, Cincinnati, Ohio, United States, 45219

Oklahoma City

Ascendis Pharma Investigational Site, Oklahoma City, Oklahoma, United States, 73104

Pittsburgh

Ascendis Pharma Investigational Site, Pittsburgh, Pennsylvania, United States, 15232

Nashville

Ascendis Pharma Investigational Site, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ascendis Pharma Oncology Division A/S,

Davis Torrejon-Castro, STUDY_DIRECTOR, Medical Monitor

Study Record Dates

2029-08