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TransCon IL-2 β/γ / TransCon TLR7/8 Agonist / Locally Advanced Solid Tumor · Phase 1/2 Trial
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record documenting a planned first-in-human Phase 1/2 study of TransCon IL-2 β/γ as monotherapy or in combination with checkpoint inhibitors, targeted therapies, and/or TLR7/8 agonist in advanced and metastatic solid tumors. No efficacy or safety results are reported in this registry entry; the record describes study design and enrollment only.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor, Platinum-resistant Ovarian Cancer, Post Anti-PD-1 Melanoma, 2L+ Cervical Cancer, Ne…; age from 18 Years. Intervention: Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ; Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with…; Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with S…; Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with T…;…. n = 320. 68 sites across 10 countries.
This is a clinical trial registry record documenting a planned first-in-human Phase 1/2 study of TransCon IL-2 β/γ as monotherapy or in combination with checkpoint inhibitors, targeted therapies, and/or TLR7/8 agonist in advanced and metastatic solid tumors. No efficacy or safety results are reported in this registry entry; the record describes study design and enrollment only.
No efficacy data, response rates, adverse event rates, or dose-escalation outcomes are stated.
This registry record indicates an active study but does not provide clinical data. Clinicians and researchers should monitor for publication of results; the first-in-human design and combination strategies tested may inform future immunotherapy approaches pending efficacy and safety readouts.
First-in-human Phase 1/2 dose escalation and expansion study with no reported results; registry record documents planned enrollment and safety endpoints only.
As stated by the source record.
Quoted from the source exactly as published.
This registry record indicates an active study but does not provide clinical data. Clinicians and researchers should monitor for publication of results; the first-in-human design and combination strategies tested may inform future immunotherapy approaches pending efficacy and safety readouts.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05081609). This is a study registration, not published results. Lead sponsor: Ascendis Pharma Oncology Division A/S. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 320 participants (ACTUAL). 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; DRUG: Pembrolizumab; DRUG: Chemotherapy drug; DRUG: TransCon TLR7/8 Agonist; PROCEDURE: Surgery; DRUG: Trastuzumab; DRUG: Trastuzumab emtansine (T-DM1). Primary outcome measures: Safety and Tolerability , Through study completion, expected average of 2 years; Maximum Tolerated Dose (MTD) , Each cycle is 21 days; Recommended Phase 2 Dose (RP2D) , 12 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.