NCT05081609View on ClinicalTrials.gov

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

PHASE1/PHASE2RecruitingINTERVENTIONAL

Enrollment

345

Participants

Timeline

Start Date

January 11, 2022

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2029

Conditions

Advanced Solid TumorLocally Advanced Solid TumorMetastatic Solid TumorPlatinum-resistant Ovarian CancerPost Anti-PD-1 Melanoma2L+ Cervical CancerNeoadjuvant MelanomaNeoadjuvant Non-Small Cell Lung CancerPost Anti-PD-(L)1 Non-Small Cell Lung CancerPost Anti-PD-(L)1 Small Cell Lung CancerThird Line or Later (3L+) HER2+ Breast CancerSecond or Third Line (2L/3L) Cervical CancerThird-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

Trial Locations (69)

2298

RECRUITING

Ascendis Pharma Investigational Site, Waratah

2610

RECRUITING

Ascendis Pharma Investigational Site, Wilrijk

3199

RECRUITING

Ascendis Pharma Investigational Site, Frankston

4215

RECRUITING

Ascendis Pharma Investigational Site, Southport

5000

RECRUITING

Ascendis Pharma Investigational Site, Adelaide

5042

RECRUITING

Ascendis Pharma Investigational Site, Adelaide

10002

TERMINATED

Ascendis Pharma Investigational Site, Taipei

10032

RECRUITING

Ascendis Pharma Investigational Site, New York

10060

RECRUITING

Ascendis Pharma Investigational Site, Turin

10126

RECRUITING

Ascendis Pharma Investigational Site, Torino

11259

TERMINATED

Ascendis Pharma Investigational Site, Taipei

12100

RECRUITING

Ascendis Pharma Investigational Site, Cuneo

13620

RECRUITING

Ascendis Pharma Investigational Site, Seongnam-si

15232

RECRUITING

Ascendis Pharma Investigational Site, Pittsburgh

20133

RECRUITING

Ascendis Pharma Investigational Site, Milan

20141

RECRUITING

Ascendis Pharma Investigational Site, Milan

23298

RECRUITING

Ascendis Pharma Investigational Site, Richmond

28006

RECRUITING

Ascendis Pharma Investigational Site, Madrid

28027

RECRUITING

Ascendis Pharma Investigational Site, Madrid

28040

RECRUITING

Ascendis Pharma Investigational Site, Madrid

28041

RECRUITING

Ascendis Pharma Investigational Site, Madrid

28050

RECRUITING

Ascendis Pharma Investigational Site, Madrid

28078

TERMINATED

Ascendis Pharma Investigational Site, Huntersville

29010

RECRUITING

Ascendis Pharma Investigational Site, Málaga

30120

RECRUITING

Ascendis Pharma Investigational Site, Murcia

31008

RECRUITING

Ascendis Pharma Investigational Site, Pamplona

33011

RECRUITING

Ascendis Pharma Investigational Site, Oviedo

37134

RECRUITING

Ascendis Pharma Investigational Site, Verona

37203

RECRUITING

Ascendis Pharma Investigational Site, Nashville

40202

RECRUITING

Ascendis Pharma Investigational Site, Louisville

41009

RECRUITING

Ascendis Pharma Investigational Site, Seville

41014

RECRUITING

Ascendis Pharma Investigational Site, Seville

41124

RECRUITING

Ascendis Pharma Investigational Site, Modena

44718

RECRUITING

Ascendis Pharma Investigational Site, Canton

45219

RECRUITING

Ascendis Pharma Investigational Site, Cincinnati

46009

RECRUITING

Ascendis Pharma Investigational Site, Valencia

46014

RECRUITING

Ascendis Pharma Investigational Site, Valencia

47014

RECRUITING

Ascendis Pharma Investigational Site, Meldola

50134

RECRUITING

Ascendis Pharma Investigational Site, Florence

55041

RECRUITING

Ascendis Pharma Investigational Site, Lido di Camaiore

57124

RECRUITING

Ascendis Pharma Investigational Site, Livorno

58100

RECRUITING

Ascendis Pharma Investigational Site, Grosseto

60693

RECRUITING

Ascendis Pharma Investigational Site, Poznan

62702

RECRUITING

Ascendis Pharma Investigational Site, Springfield

73104

RECRUITING

Ascendis Pharma Investigational Site, Oklahoma City

90048

RECRUITING

Ascendis Pharma Investigational Site, Los Angeles

90067

RECRUITING

Ascendis Pharma Investigational Site, Los Angeles

119228

RECRUITING

Ascendis Pharma Investigational Site, Singapore

217562

RECRUITING

Ascendis Pharma Investigational Site, Singapore

02114

RECRUITING

Ascendis Pharma Investigational Site, Boston

07960

RECRUITING

Ascendis Pharma Investigational Site, Morristown

04120

RECRUITING

Ascendis Pharma Investigational Site, Brisbane

05065

TERMINATED

Ascendis Pharma Investigational Site, Toorak Gardens

H2X-0A9

WITHDRAWN

Ascendis Pharma Investigational Site, Montreal

H4A 3J1

RECRUITING

Ascendis Pharma Investigational Site, Montreal

M4N 3M5

RECRUITING

Ascendis Pharma Investigational Site, Toronto

M5G 2C4

RECRUITING

Ascendis Pharma Investigational Site, Toronto

00167

RECRUITING

Ascendis Pharma Investigational Site, Roma

31-501

RECRUITING

Ascendis Pharma Investigational Site, Krakow

02-781

RECRUITING

Ascendis Pharma Investigational Site, Warsaw

05505

RECRUITING

Ascendis Pharma Investigational Site, Seoul

03080

RECRUITING

Ascendis Pharma Investigational Site, Seoul

03722

RECRUITING

Ascendis Pharma Investigational Site, Seoul

06231

RECRUITING

Ascendis Pharma Investigational Site, Seoul

06351

RECRUITING

Ascendis Pharma Investigational Site, Seoul

08023

RECRUITING

Ascendis Pharma Investigational Site, Barcelona

08028

RECRUITING

Ascendis Pharma Investigational Site, Barcelona

08035

RECRUITING

Ascendis Pharma Investigational Site, Barcelona

08908

RECRUITING

Ascendis Pharma Investigational Site, L'Hospitalet de Llobregat

All Listed Sponsors

lead

Ascendis Pharma Oncology Division A/S

INDUSTRY