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Clinical Trial Record

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

2022-07-13

2025-04-17

2025-04-17

128

Study Overview

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

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.

N/A

  • Advanced Solid Tumors
  • DRUG: ADCT-601
  • DRUG: Gemcitabine
  • ADCT-601-102
  • 2021-005566-18 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-05-20  

N/A  

2025-05-19  

2022-05-20  

N/A  

2025-05-22  

2022-05-25  

N/A  

2025-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: 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.

DRUG: ADCT-601

  • Intravenous (IV) infusion

DRUG: Gemcitabine

  • Intravenous (IV) infusion
EXPERIMENTAL: 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

DRUG: ADCT-601

  • Intravenous (IV) infusion
EXPERIMENTAL: 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.

DRUG: ADCT-601

  • Intravenous (IV) infusion

DRUG: Gemcitabine

  • Intravenous (IV) infusion
EXPERIMENTAL: 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

DRUG: ADCT-601

  • Intravenous (IV) infusion
Primary Outcome MeasuresMeasure DescriptionTime Frame
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs)Adverse events (AEs) and serious adverse events (SAEs) are 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 years
Number of Participants who Experience a Dose Limiting Toxicity (DLT)Day 1 to Day 21
Number of Participants who Experience a Dose InterruptionUp to approximately 2 years
Number of Participants who Experience a Dose ReductionUp to approximately 2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Overall Response Rate (ORR)Up to approximately 2 years
Duration of Response (DOR)Up to approximately 2 years
Progression-Free Survival (PFS)Up to approximately 2 years
Overall Survival (OS)Up to approximately 2 years
Serum Concentration of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199Day 1 up to approximately 2 years
Maximum Concentration (Cmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in SerumDay 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in SerumDay 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in SerumDay 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in SerumDay 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time Zero to Infinity (AUCinf) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in SerumDay 1 up to approximately 2 years
Apparent Terminal Elimination Half-life (T1/2) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in SerumDay 1 up to approximately 2 years
Apparent Clearance (CL) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in SerumDay 1 up to approximately 2 years
Apparent Steady-state Volume of Distribution (Vss) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in SerumDay 1 up to approximately 2 years
Accumulation Index (AI) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in SerumDay 1 up to approximately 2 years
Number of Participants With an Anti-drug Antibody (ADA) Response to ADCT-601Day 1 up to approximately 2 years
Number of Participants With Anti-drug Antibody (ADA) Titers to ADCT-601Day 1 up to approximately 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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