Clinical trial NCT06797999: First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
Official title: A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Metastatic Soft Tissue Sarcoma
Unresectable Soft Tissue Sarcoma
Keywords: Phase 1/Phase 2
Sequential
Treatment
Lead sponsor: Adcendo ApS
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.
timeFrame: From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)
measure: Assess the safety and tolerability of ADCE-D01
timeFrame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Secondary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
measure: ADCE-D01 time to Cmax (Tmax)
timeFrame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
measure: ADCE-D01 area under the concentration-time curve (AUC)
timeFrame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
measure: Evaluate ADCE-D01 objective response rate (ORR)
timeFrame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
measure: Evaluate ADCE-D01 duration of response (DOR)
timeFrame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
measure: ADCE-D01 progression-free survival (PFS)
timeFrame: Throughout the trial duration, completion expected approximately 18 months from completed enrollmen
measure: ADCE-D01 clinical benefit rate (CBR)
timeFrame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
measure: ADCE-D01 time to response (TTR)
timeFrame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Miami
country: United States
facility: University of Miami - Sylvester Comprehensive Cancer Center
state: Florida
city: New York City
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: University Of Texas MD Anderson Cancer Center
state: Texas
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
city: Lyon
country: France
facility: Centre Léon Bérard
city: Essen
country: Germany
facility: Universitätsklinikum Essen West German Tumor Center
city: London
country: United Kingdom
facility: Royal Marsden
Study officials:
References: