# 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

> **NCT05081609** · PHASE1,PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Ascendis Pharma Oncology Division A/S** · enrollment: 320 (actual)

## Conditions studied

- 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
- **DRUG:** Pembrolizumab
- **DRUG:** Chemotherapy drug
- **DRUG:** TransCon TLR7/8 Agonist
- **PROCEDURE:** Surgery
- **DRUG:** Trastuzumab
- **DRUG:** Trastuzumab emtansine (T-DM1)

## Key facts

- **NCT ID:** NCT05081609
- **Lead sponsor:** Ascendis Pharma Oncology Division A/S
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-01-11
- **Primary completion:** 2027-08
- **Final completion:** 2029-08
- **Target enrollment:** 320 (ACTUAL)
- **Last updated:** 2026-02-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05081609

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05081609, "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". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT05081609. Licensed CC0.

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