Contacts

René Smrčka

CONTACT

+45 3144 0653 rene.smrcka@adcendo.com

Margaret McNaull

CONTACT

+44 7818 457619.margaret.mcnaull@adcendo.com

Sponsors

Lead Sponsor

Adcendo ApS

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. ≥ 18 years of age
•2. Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
•3. Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
•4. Measurable disease as per RECIST v 1.1.
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•6. Life expectancy of at least 3 months.
•7. A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate.

Exclusion Criteria

•1. Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
•2. Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
•3. Clinically significant cardiovascular disease
•4. Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
•5. Current active liver disease due to hepatitis B
•6. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.

Related studies

RECRUITINGPhase 1/2

SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma

NCT03138161 · Advanced Soft Tissue Sarcoma, Metastatic Soft Tissue Sarcoma

Active Not RecruitingPhase 2

Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma

NCT05836571 · Locally Advanced Extraskeletal Myxoid Chondrosarcoma, Locally Advanced Leiomyosarcoma, and more

Active Not RecruitingPhase 2

Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma

NCT04200443 · Metastatic Leiomyosarcoma, Metastatic Soft Tissue Sarcoma, and more

Active Not RecruitingPhase 1

Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors

NCT05075993 · Metastatic Esophageal, Gastric Cancer, and more

COMPLETEDPhase 2

Phase II Study of Regorafenib as Maintenance Therapy

NCT03793361 · Metastatic Soft Tissue Sarcoma

View all related studies →

First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma

What this study is about

Clareo turns complex medical information into clear understanding you can use.

Contacts

Sponsors

Related studies

SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma

Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma

Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma

Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors

Phase II Study of Regorafenib as Maintenance Therapy

Trial snapshot

Condition

Locations shown

For caregivers