A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors

NCT04972981 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: ADCT-901-1012021-002292-19
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 13

Brief Summary

The primary objectives of this study are to identify the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), and to characterize the safety and the tolerability of ADCT-901.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; ADCT-901

Outcome Measures

Primary Outcomes (4)

• Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs)

  Adverse events (AEs) and serious adverse events (SAEs) were defined as any untoward medical occurrence in participants whether or not considered related to the investigational medicinal product. Any clinically significant changes in vital signs, laboratory values, 12-lead electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status results will be recorded as AEs and SAEs.

  Up to approximately 2.5 years

• Number of Participants Who Experience a Dose Limiting Toxicity (DLT) During the Dose-Escalation Phase

  Day 1 to Day 21

• Number of Participants Who Experience a Dose Interruption

  Up to approximately 2.5 years

• Number of Participants Who Experience a Dose Reduction

  Up to approximately 2.5 years

Secondary Outcomes (14)

• Overall Response Rate (ORR)

  Up to approximately 2.5 years

• Duration of Response (DOR)

  Up to approximately 2.5 years

• Progression-Free Survival (PFS)

  Up to approximately 2.5 years

• Overall Survival (OS)

  Up to approximately 2.5 years

• Maximum Concentration (Cmax) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum

  Up to approximately 2.5 years

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

In Part 1 (dose escalation) participants with selected advanced solid tumors will receive escalating doses of ADCT-901 as monotherapy. Participants can receive ADCT-901 until disease progression, adverse event (AE), or other discontinuation criteria, whichever occurs first.

Drug: ADCT-901

Part 2: Dose Expansion

EXPERIMENTAL

In Part 2 (dose expansion), participants will receive ADCT-901 monotherapy at the dose identified as the RP2D/MTD in Part 1 (dose escalation). Participants will be split into two groups: Group 1: An indication for which ADCT-901 showed in Part 1 to have preliminary activity. Group 2: A group of participants with Part 1 indications, except for the one selected in Group 1 of Part 2. No more than 30% of participants with the same indication are allowed in this basket group. Participants can receive ADCT-901 until disease progression, AE, or other discontinuation criteria, whichever occurs first.

Drug: ADCT-901

Interventions

ADCT-901 DRUG

Intravenous infusion

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic diagnosis of selected solid tumor malignancy that is locally advanced or metastatic at time of Screening: cholangiocarcinoma, ovarian/fallopian tube cancers, prostate cancer, renal cell carcinoma, and triple negative breast cancer (TNBC).
• Note: Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are permitted.
• Participants who are refractory to or intolerant to existing therapy(ies) known to provide clinical benefit for their condition per Investigator judgment.
• Participants with measurable disease as determined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1:
• Note 1: Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that can be evaluated by cross sectional imaging techniques such as computed tomography (CT) or magnetic resonance imaging (MRI) can be considered as measurable lesions only if the soft tissue component meets the definition of measurability per RECIST v1.1.
• Note 2: Prostate cancer participants without measurable lesions will be accepted, with evidence of bone metastatic disease on radiographic examination, whether from bone scan or other imaging modality, and prostate specific antigen (PSA) ≥2.0 ng/mL.

You may not qualify if:

• History of active infection (requiring intravenous \[IV\] antibiotics, IV antiviral or IV antifungal treatment within 4 weeks of cycle 1, day 1 \[C1D1\]).
• Symptomatic central nervous system (CNS) metastases or evidence of leptomeningeal disease (brain MRI or previously documented cerebrospinal fluid cytology). Previously treated asymptomatic CNS metastases are permitted provided that the last treatment (systemic anticancer therapy and/or local radiotherapy) was completed ≥4 weeks prior to C1D1 except usage of low dose of steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 and consecutive days is permissible if being tapered down). Participants with discrete dural metastases are eligible.
• Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requiring drainage or associated with shortness of breath).
• Active diarrhea ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease).
• Active or clinically significant ocular surface disease at baseline. An ocular evaluation is to be confirmed by an ophthalmologist at screening. Participants with any prior episode of cicatricial conjunctivitis (as evaluated by the investigator) are ineligible.
• Use of any other experimental medication within 14 days prior to start of study drug (C1D1).

Sponsors & Collaborators

• ADC Therapeutics S.A.: lead

Study Sites (13)

Sarah Cannon at HealthONE

Denver, Colorado, 80218, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Emory University, Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University Hospitals of Cleveland Medical Center (UHCMC)

Cleveland, Ohio, 44106, United States

Location

Sarah Cannon at University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Institut Catala D'oncologia (ICO) - Hospital Duran I Reynals Location

Badalona, Barcelona, 08908, Spain

Location

Hospital Universitari Vall D'hebron - Vall D'hebron Institut D'oncologia (VHIO)

Barcelona, 08035, Spain

Location

(START) Madrid - Hospital Universitario Fundación Jiménez Díaz Location

Madrid, 28040, Spain

Location

Universidad Complutense de Madrid - Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Imperial College Healthcare NHS Trust - St Mary's Hospital

London, England, W12 0HS, United Kingdom

Location

Sarah Cannon Research Institute (SCRI) - London (SCRI-UK)

London, England, W1G 6AD, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: September 9, 2021
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); US (7); ES (4)