Safety, Tolerability, Pharmacokinetics, and Antitumor Study of ADCT-601 to Treat Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03700294|
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
|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|
|Estimated Study Start Date :||November 16, 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.
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: David Ungar, MDemail@example.com|
|Contact: Maria Cincottafirstname.lastname@example.org|
|United States, Texas|
|NEXT Oncology||Not yet recruiting|
|San Antonio, Texas, United States, 78240|
|Contact: Anthony W Tolcher, MD|