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

Phase 1

Recruiting

• Conditions: Metastatic Soft Tissue Sarcoma; Unresectable Soft Tissue Sarcoma
• Interventions: Biological: Antibody-drug conjugate (ADC)

• Registration Number: NCT06797999
• Lead Sponsor: Adcendo ApS

Brief Summary

The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.

Detailed Description

Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.

Study Timeline

• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-29
• Study Start: 2025-03-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2029-02-27
• Study Completion: 2029-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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.
8. A female patient is eligible if not pregnant, not breast feeding, and not a woman of childbearing potential (WOCBP), or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ADCE-D01	Antibody-drug conjugate (ADC)	ADCE-D01

Primary Outcome Measures

Name	Time	Method
Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.	From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)	Measuring incidence of dose-limiting toxicities (DLTs)
Assess the safety and tolerability of ADCE-D01	Throughout the trial duration, completion expected approximately 18 months from completed enrollment	Nature, incidence, severity and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0).; Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation.

Secondary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax)	Throughout the trial duration, completion expected approximately 18 months from completed enrollment	Time to maximum plasma concentration will be assessed to inform ADCE-D01 PK profile
ADCE-D01 time to Cmax (Tmax)	Throughout the trial duration, completion expected approximately 18 months from completed enrollment	Time to Cmax (Tmax) will be assessed to characterize the ADCE-D01 PK profile
Evaluate ADCE-D01 duration of response (DOR)	Throughout the trial duration, completion expected approximately 18 months from completed enrollment	Duration of response DOR, measured per RECIST v1.1 by Investigator assessment will be used to further characterize the durability of tumor response of ADCE-D01
ADCE-D01 area under the concentration-time curve (AUC)	Throughout the trial duration, completion expected approximately 18 months from completed enrollment	ADCE-D01 area under the concentration-time curve (AUC) will be assessed to characterize PK profile
Evaluate ADCE-D01 objective response rate (ORR)	Throughout the trial duration, completion expected approximately 18 months from completed enrollment	Objective response rate (ORR) per RECIST v1.1 by Investigator assessment
ADCE-D01 clinical benefit rate (CBR)	Throughout the trial duration, completion expected approximately 18 months from completed enrollment	clinical benefit rate (CBR) assessed by Investigator per RECIST version 1.1 to evaluate preliminary antitumor activity of ADCE-D01
ADCE-D01 progression-free survival (PFS)	Throughout the trial duration, completion expected approximately 18 months from completed enrollmen	Progression-free survival (PFS) assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity.
ADCE-D01 time to response (TTR)	Throughout the trial duration, completion expected approximately 18 months from completed enrollment	time to response (TTR) assessed by Investigator per RECIST version 1.1 to evaluate preliminary antitumor activity of ADCE-D01

Trial Locations

Locations (8)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

University of Miami - Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York City, New York, United States

University Of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Centre Léon Bérard; 🇫🇷 Lyon, France

Universitätsklinikum Essen West German Tumor Center; 🇩🇪 Essen, Germany

Royal Marsden; 🇬🇧 London, United Kingdom