A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors

NCT ID: NCT05389462

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2025-04-17

Brief Summary

The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Dose Escalation, ADCT-601 Combination Therapy

In Part 1 (dose escalation), participants with selected sarcoma indications will receive escalating doses of ADCT-601 in combination with gemcitabine.

Group Type: EXPERIMENTAL

ADCT-601

Intervention Type: DRUG

Intravenous (IV) infusion

Gemcitabine

Intervention Type: DRUG

Intravenous (IV) infusion

Part 1: Dose Escalation, ADCT-601 Monotherapy

In Part 1 (dose escalation), participants with sarcoma indications (regardless of AXL gene amplification status), non-small-cell lung cancer (NSCLC) (regardless of AXL gene amplification status), and solid tumors with AXL gene amplification, will receive ADCT-601 monotherapy.

Group Type: EXPERIMENTAL

ADCT-601

Intervention Type: DRUG

Intravenous (IV) infusion

Part 2: Dose Expansion, ADCT-601 Combination Therapy

In Part 2 (dose expansion), participants with selected sarcoma indications will receive ADCT-601 in combination with gemcitabine.

Participants will be split into 3 cohorts:

Cohorts 5 and 6: Sarcoma indications.

Cohort 7: Pancreatic cancer.

Group Type: EXPERIMENTAL

ADCT-601

Intervention Type: DRUG

Intravenous (IV) infusion

Gemcitabine

Intervention Type: DRUG

Intravenous (IV) infusion

Part 2: Dose Expansion, ADCT-601 Monotherapy

In Part 2 (dose expansion), participants with a selected indication will receive ADCT-601 monotherapy.

Participants will be split into cohorts:

Cohort 1: Soft tissue sarcoma (STS).

Cohort 2: Pancreatic adenocarcinoma (PAAD).

Cohort 3: NSCLC.

Cohort 4: Solid tumors with known AXL expression.

Group Type: EXPERIMENTAL

ADCT-601

Intervention Type: DRUG

Intravenous (IV) infusion

Interventions

ADCT-601

Intravenous (IV) infusion

Intervention Type: DRUG

Gemcitabine

Intravenous (IV) infusion

Intervention Type: DRUG

Other Intervention Names

Mipasetamab uzoptirine

Eligibility Criteria

Inclusion Criteria

1. Male or female participant aged 18 years or older.

2. Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening:

Part 1:

1. Combination therapy arms: Selected sarcoma indications from the following 2 separate categories.

• Soft tissue sarcoma: leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma (UPS; covering malignant fibrous histiocytoma) and synovial sarcoma.
• Bone sarcoma: Ewing's sarcoma (including extraskeletal), osteosarcoma, and chondrosarcoma.

2. Monotherapy arms:

• Sarcoma indications (including those listed for combination therapy arms) regardless of AXL gene amplification status.
• NSCLC regardless of AXL gene amplification status.
• Solid tumors (lymphomas participants are excluded) with known AXL gene amplification.

Part 2:

1. Combination therapy arms: Sarcoma indications and PAAD.

2. Monotherapy arms: PAAD, NSCLC and solid tumors with AXL expression.

3. Participants who are refractory to or intolerant to available standard therapy(ies) known to provide clinical benefit for their condition per Investigator judgment.

4. Participants with measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.

6. PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1.

Exclusion Criteria

1. History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).

2. Symptomatic central nervous system (CNS) metastases or evidence of leptomeningeal disease (brain magnetic resonance imaging [MRI] or previously documented cerebrospinal fluid [CSF] 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 Day 1 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.

3. 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).

4. 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).

5. Use of any other experimental medication within 14 days prior to start of study drug (C1D1).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADC Therapeutics S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sarcoma Oncology Research Center

Santa Monica, California, United States

Stanford Cancer Center, Stanford Medicine at Stanford University

Stanford, California, United States

University of IOWA

Iowa City, Iowa, United States

Washington University School of Medicine

St Louis, Missouri, United States

Sarah Cannon at University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Vanderbilt University Medical Center (VUMC) - Ingram Cancer Center

Nashville, Tennessee, United States

Institut Bergonié

Bordeaux, Gironde, France

Institut Léon Bérard

Lyon, , France

Centre Antoine Lacassagne

Nice, , France

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario Madrid Sanchinarro

Madrid, , Spain

The Royal Marsden NHS Foundation Trust

London, England, United Kingdom

The Christie NHS Foundation Trust

Manchester, England, United Kingdom

Countries

United States; France; Spain; United Kingdom

Other Identifiers

2021-005566-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ADCT-601-102

Identifier Type: -

Identifier Source: org_study_id