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 : Recruiting
First Posted : October 9, 2018
Last Update Posted : June 17, 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 3-6 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 to 42 - day cycle for each patient depending if patient is treated every 3, 4 or 6 weeks (dose escalation only) ]Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
- Maximum Tolerated Dose [ Time Frame: Treatment cycle is every 3-6 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.
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
|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|