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

NCT03700294 | Terminated Phase 1 FDA Drug

• 1 other identifier: ADCT-601-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity

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

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

• Maximum Tolerated Dose

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

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

Secondary Outcomes (4)

• Overall response rate (ORR)

  Up to 2 Years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

ADCT-601

EXPERIMENTAL

Drug: ADCT-601

Interventions

ADCT-601 DRUG

Intravenous (IV)

ADCT-601

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Known history of ≥ Grade 3 hypersensitivity to a therapeutic antibody.
• 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).
• 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.

Sponsors & Collaborators

• ADC Therapeutics S.A.: lead

Study Sites (4)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

The Sarah Cannon Research Institute (Tennessee Oncology)

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology

San Antonio, Texas, 78240, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: December 21, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

US (4)