Safety, Tolerability, Pharmacokinetics, and Antitumor Study of ADCT-601 to Treat Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03700294|
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: ADCT-601||Phase 1|
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)|
|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|
|Actual Study Start Date :||December 21, 2018|
|Estimated Primary Completion Date :||November 25, 2020|
|Estimated Study Completion Date :||January 1, 2021|
- 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)
- 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
- 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).
- 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.
- 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.
- Overall survival (OS) [ Time Frame: Up to 2 years ]Defined as the time between the start of treatment and death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700294
|Contact: ADC Therapeuticsfirstname.lastname@example.org|
|United States, Colorado|
|Sarah Cannon Research Institute at HealthONE||Recruiting|
|Denver, Colorado, United States, 80218|
|Contact: Gerald Falchook, MD, MS 281-221-0693 email@example.com|
|United States, Florida|
|Florida Cancer Specialists||Recruiting|
|Sarasota, Florida, United States, 34232|
|Contact: Manish R Patel, MD 941-377-9993 firstname.lastname@example.org|
|United States, Tennessee|
|The Sarah Cannon Research Institute (Tennessee Oncology)||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Johanna C Bendell, MD 615-329-7274|
|United States, Texas|
|San Antonio, Texas, United States, 78240|
|Contact: Anthony W Tolcher, MD 210-300-9044 email@example.com|