ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03700294
Previous Study | Return to List | Next Study

Safety, Tolerability, Pharmacokinetics, and Antitumor Study of ADCT-601 to Treat Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03700294
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
ADC Therapeutics S.A.

Brief Summary:
This study evaluated the safety, tolerance, pharmacokinetics (PK), and antitumor activity of ADCT-601 in patients with advanced solid tumors.

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

Detailed Description:

This is a Phase 1 open-label, multicenter single-arm study with a dose-escalation phase (Part 1) followed by a dose-expansion phase (Part 2). The study will enroll approximately 75 patients. A standard 3+3 dose-escalation design will be used for Part 1 in order to determine the MTD and/or recommended dose for expansion (RDE).

Part 2 will consist of 3 cohorts from one or more selected tumor types. Each cohort will enroll 15 patients.

The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3 weeks), and a Follow-up Period (visits approximately every 12 weeks for up to 2 years after treatment discontinuation).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-601 in Patients With Advanced Solid Tumors
Estimated Study Start Date : November 16, 2018
Estimated Primary Completion Date : November 25, 2020
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Experimental: ADCT-601 Drug: ADCT-601
Intravenous (IV)




Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: First 21-day cycle for each patient (dose escalation only) ]
    Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)

  2. Maximum Tolerated Dose [ Time Frame: Treatment cycle is every 3 weeks. Patients followed every 12 weeks for up to 2 years after treatment ]
    Incidence of dose-limiting toxicities (DLTs) and frequency of dose interruptions and dose reductions


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Up to 2 Years ]
    According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR).

  2. Disease control rate (DCR) [ Time Frame: Up to 2 years ]
    According to the RECIST 1.1 defined as the proportion of patients with a BOR of CR, PR, or SD.

  3. Duration of response (DOR) [ Time Frame: Up to 2 years ]
    Defined as the time from the documentation of first tumor response to disease progression or death.

  4. Overall survival (OS) [ Time Frame: Up to 2 years ]
    Defined as the time between the start of treatment and death from any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 patient aged 18 years or older.
  2. Pathologic diagnosis of one of the following solid tumor malignancies which is locally advanced or metastatic at screening:

    1. Breast cancer which is ER negative, partial response (PR) negative, and HER2 negative
    2. Colorectal cancer
    3. Esophageal cancer
    4. Gastric cancer
    5. Head and neck cancer (squamous cell carcinoma and nasopharyngeal carcinoma)
    6. Mesothelioma
    7. Non-small cell lung cancer
    8. Ovarian cancer
    9. Pancreatic cancer
    10. Soft Tissue Sarcomas
  3. Patients with relapsed or refractory disease who have failed, or are intolerant to, any established therapy; or for whom no other treatment options are available, in the opinion of the Investigator.
  4. Measurable disease per RECIST 1.1.
  5. Patient must agree to biopsy of tumor for study biomarker testing.
  6. Eastern Cooperative Oncology Group performance status, 0 to 1.
  7. Adequate organ function as defined by screening laboratory values within the following parameters:

    1. Absolute neutrophil count (ANC) ≥ 1.5 × 103/µL (off growth factors at least 72 hours)
    2. Platelet count ≥100 x 103/µL without transfusion
    3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) ≤ 2.5 × the upper limit of normal (ULN); ≤ 5 × ULN if there is liver involvement with tumor
    4. Total bilirubin ≤ 1.5 × ULN (patients with known Gilbert's syndrome may have a total bilirubin up to ≤ 3 × ULN)
    5. Blood creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 60 mL/min by the Cockcroft and Gault equation.
  8. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug (C1D1) for women of childbearing potential.
  9. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of ADCT-601. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of ADCT-601.

Exclusion Criteria:

  1. Known history of ≥ Grade 3 hypersensitivity to a therapeutic antibody.
  2. Active second primary malignancy other than nonmelanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary.
  3. Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll, provided the trigger can be avoided.
  4. Known seropositive and requiring antiviral therapy for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
  5. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
  6. Symptomatic 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 ≥ 8 weeks prior to Day 1 except usage of low dose of steroids on a taper (ie, up to 10 mg on Day 1 and consecutive days is permissible if being tapered down). Patients with discrete dural metastases are eligible.

  7. Clinically significant third space fluid accumulation (ie, ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
  8. Breastfeeding or pregnant.
  9. Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure [BP] ≥ 160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease.
  10. Major surgery, radiotherapy, chemotherapy, or other antineoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor.
  11. Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
  12. Planned live vaccine administration after starting study drug (C1D1).
  13. Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from acute non-hematologic toxicity (Grade ≤ 2 neuropathy or alopecia) due to previous therapy prior to screening.
  14. Congenital long QT syndrome or a corrected QTcF interval of > 480 ms at screening (unless secondary to pacemaker or bundle branch block).
  15. Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk.

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): NCT03700294


Contacts
Contact: David Ungar, MD 908-864-6988 david.ungar@adctherapeutics.com
Contact: Maria Cincotta maria.cincotta@adctherapeutics.com

Locations
United States, Texas
NEXT Oncology Not yet recruiting
San Antonio, Texas, United States, 78240
Contact: Anthony W Tolcher, MD         
Sponsors and Collaborators
ADC Therapeutics S.A.

Responsible Party: ADC Therapeutics S.A.
ClinicalTrials.gov Identifier: NCT03700294     History of Changes
Other Study ID Numbers: ADCT-601-101
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No