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Trial record 1 of 1 for:    ADCT-601-102
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A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors

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ClinicalTrials.gov Identifier: NCT05389462
Recruitment Status : Recruiting
First Posted : May 25, 2022
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
ADC Therapeutics S.A.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: ADCT-601 Drug: Gemcitabine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors
Actual Study Start Date : July 13, 2022
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

Arms and Interventions
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Arm Intervention/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
Other Name: Mipasetamab uzoptirine

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 ADCT-601 monotherapy.
 Drug: ADCT-601
Intravenous (IV) infusion
Other Name: Mipasetamab uzoptirine
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
Other Name: Mipasetamab uzoptirine

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: Solid tumors with known AXL expression.

 Drug: ADCT-601
Intravenous (IV) infusion
Other Name: Mipasetamab uzoptirine


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 2 years ]
    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.

  2. Number of Participants who Experience a Dose Limiting Toxicity (DLT) [ Time Frame: Day 1 to Day 21 ]
  3. Number of Participants who Experience a Dose Interruption [ Time Frame: Up to approximately 2 years ]
  4. Number of Participants who Experience a Dose Reduction [ Time Frame: Up to approximately 2 years ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]
  2. Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ]
  3. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 2 years ]
  4. Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
  5. Serum Concentration of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 [ Time Frame: Day 1 up to approximately 2 years ]
  6. Maximum Concentration (Cmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  7. Time to Maximum Concentration (Tmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  8. 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 Serum [ Time Frame: Day 1 up to approximately 2 years ]
  9. 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 Serum [ Time Frame: Day 1 up to approximately 2 years ]
  10. 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 Serum [ Time Frame: Day 1 up to approximately 2 years ]
  11. Apparent Terminal Elimination Half-life (T1/2) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  12. Apparent Clearance (CL) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  13. Apparent Steady-state Volume of Distribution (Vss) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  14. Accumulation Index (AI) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  15. Number of Participants With an Anti-drug Antibody (ADA) Response to ADCT-601 [ Time Frame: Day 1 up to approximately 2 years ]
  16. Number of Participants With Anti-drug Antibody (ADA) Titers to ADCT-601 [ Time Frame: Day 1 up to approximately 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389462


Contacts
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Contact: Contact ADC Therapeutics 954-903-7994 clinical.trials@adctherapeutics.com

Locations
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United States, California
Sarcoma Oncology Research Center Recruiting
Santa Monica, California, United States, 90403
Stanford Cancer Center, Stanford Medicine at Stanford University Recruiting
Stanford, California, United States, 94304
United States, Iowa
University of IOWA Recruiting
Iowa City, Iowa, United States, 52242
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, Oklahoma
Sarah Cannon at University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact       Phase1-Referrals@ouhsc.edu   
United States, Tennessee
Vanderbilt University Medical Center (VUMC) - Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
France
Institut Bergonié Recruiting
Bordeaux, Gironde, France, 33076
Institut Léon Bérard Recruiting
Lyon, France, 69008
Centre Antoine Lacassagne Recruiting
Nice, France, 06100
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario Madrid Sanchinarro Recruiting
Madrid, Spain, 28050
United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
ADC Therapeutics S.A.
More Information
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Responsible Party: ADC Therapeutics S.A.
ClinicalTrials.gov Identifier: NCT05389462    
Other Study ID Numbers: ADCT-601-102
2021-005566-18 ( EudraCT Number )
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ADC Therapeutics S.A.:
Advanced solid tumors
Mipasetamab uzoptirine
ADCT-601
Sarcoma
 Gemcitabine
AXL
Pancreatic cancer
NSCLC
Additional relevant MeSH terms:
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Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents