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ACTIVE NOT RECRUITING

NCT05081609

PHASE1/PHASE2

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

Sponsor: Ascendis Pharma Oncology Division A/S

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2022-01-11

Completion Date

2029-08

Last Updated

2026-02-24

Healthy Volunteers

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 Third-line or Later (3L+) Platinum-resistant Ovarian Cancer (PROC)

Interventions

DRUG

TransCon IL-2 β/γ

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

DRUG

Pembrolizumab

Pembrolizumab will be administered as an intravenous (IV) infusion

DRUG

Chemotherapy drug

SOC chemotherapy will be administered as an intravenous (IV) infusion

DRUG

TransCon TLR7/8 Agonist

TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection

PROCEDURE

Surgery

Surgery will take place 4-6 weeks after last dose of study treatment.

DRUG

Trastuzumab

Trastuzumab will be administered as an intravenous (IV) infusion

DRUG

Trastuzumab emtansine (T-DM1)

Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion

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