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

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.

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 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

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

Sponsors & Collaborators

• Ascendis Pharma Oncology Division A/S

  lead INDUSTRY

Principal Investigators

• Davis Torrejon-Castro · Medical Monitor

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-11

Primary Completion

2027-08-31

Completion

2029-08-31

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• Canada
• Italy
• Poland
• Singapore
• South Korea
• Spain
• Taiwan

Study Locations