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Advanced Solid TumorsPhase 1NCT03700294

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

A Phase 1 study testing ADCT-601 in people with Advanced Solid Tumors, run by ADC Therapeutics S.A. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study evaluates the safety, tolerance, pharmacokinetics (PK), and antitumor activity of ADCT-601 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ADCT-601
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesUnited States
Study dates
21 Dec 2018to 11 Dec 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patient aged 18 years or older.
  • Pathologic diagnosis of one of the following solid tumor malignancies which is locally advanced or metastatic at screening:
  • Breast cancer which is ER negative, partial response (PR) negative, and HER2 negative
  • Colorectal cancer
  • Esophageal cancer
  • Gastric cancer
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  • Head and neck cancer (squamous cell carcinoma and nasopharyngeal carcinoma)
  • Mesothelioma
  • Non-small cell lung cancer
  • Ovarian cancer
  • Pancreatic cancer
  • Soft Tissue Sarcomas
  • 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.
  • Measurable disease per RECIST 1.1.
  • Patient must agree to biopsy of tumor for study biomarker testing.
  • Eastern Cooperative Oncology Group performance status, 0 to 1.
  • Adequate organ function as defined by screening laboratory values within the following parameters:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 103/µL (off growth factors at least 72 hours)
  • Platelet count ≥100 x 103/µL without transfusion
  • 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
  • Total bilirubin ≤ 1.5 × ULN (patients with known Gilbert's syndrome may have a total bilirubin up to ≤ 3 × ULN)
  • Blood creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 60 mL/min by the Cockcroft and Gault equation.
  • Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug (C1D1) for women of childbearing potential.
  • 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.

Who cannot join

  • Known history of ≥ Grade 3 hypersensitivity to a therapeutic antibody.
  • 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.
  • 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.
  • Known seropositive and requiring antiviral therapy for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
  • History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
  • Symptomatic CNS metastases or evidence of leptomeningeal disease (brain MRI or previously documented cerebrospinal fluid cytology).
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  • 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.
  • Clinically significant third space fluid accumulation (ie, ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
  • Breastfeeding or pregnant.
  • 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.
  • 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.
  • Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
  • Planned live vaccine administration after starting study drug (C1D1).
  • 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.
  • Congenital long QT syndrome or a corrected QTcF interval of > 480 ms at screening (unless secondary to pacemaker or bundle branch block).
  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • The Sarah Cannon Research Institute (Tennessee Oncology)

    Nashville, Tennessee, 37203

  • NEXT Oncology

    San Antonio, Texas, 78240

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

About this study

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

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

Read the 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 3-6 weeks), and a Follow-up Period (visits approximately every 12 weeks for up to 2 years after treatment discontinuation).

Being tested
ADCT-601

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADCT-601Drug

    Intravenous (IV)

Study groups in NCT03700294
Study groupRoleWhat they receive
ADCT-601ExperimentalNot described
Receives: Drug: ADCT-601

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity

    Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)

    Measured: First 21 to 42 - day cycle for each patient depending if patient is treated every 3, 4 or 6 weeks (dose escalation only)

  2. Maximum Tolerated Dose

    Incidence of dose-limiting toxicities (DLTs) and frequency of dose interruptions and dose reductions

    Measured: Treatment cycle is every 3-6 weeks. Patients followed every 12 weeks for up to 2 years after treatment

Secondary outcomes (4)

  1. Overall response rate (ORR)

    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).

    Measured: Up to 2 Years

  2. Disease control rate (DCR)

    According to the RECIST 1.1 defined as the proportion of patients with a BOR of CR, PR, or SD.

    Measured: Up to 2 years

  3. Duration of response (DOR)

    Defined as the time from the documentation of first tumor response to disease progression or death.

    Measured: Up to 2 years

  4. Overall survival (OS)

    Defined as the time between the start of treatment and death from any cause.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start21 Dec 2018
  3. Primary completion11 Dec 2019
  4. Study completion11 Dec 2019

Why it stopped: Change in clinical plan and drug supply

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03700294
Sponsor's protocol ID
ADCT-601-101
Status last verified
Apr 2020
First submitted
3 Oct 2018
Last updated
1 May 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADCT-601 in people with Advanced Solid Tumors, run by ADC Therapeutics S.A. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Change in clinical plan and drug supply). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (time frame: First 21 to 42 - day cycle for each patient depending if patient is treated every 3, 4 or 6 weeks (dose escalation only)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03700294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.

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