Clinical trial NCT06036121: A Study of ADRX-0706 in Select Advanced Solid Tumors
Official title: A Phase 1a/b Study of ADRX-0706 in Subjects with Select Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Triple Negative Breast Cancer (TNBC)
Urothelial Cancer
Cervical Cancer
Keywords: urothelial cancer
triple negative breast cancer
cervical cancer
ADC
Lead sponsor: Adcentrx Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0706 in patients with select advanced solid tumors.

Detailed description: This is a 2 part study. The Phase 1a will consist of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of ADRX-0706 in patients with urothelial cancer, triple negative breast cancer, and cervical cancer.

Eligibility criteria: Inclusion Criteria:

* Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including urothelial carcinoma (UC), head and neck squamous cell carcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. Subjects must have received at least one prior systemic regimen and have no other therapy available known to provide meaningful clinical benefit in the opinion of the investigator.
* Phase 1b Dose Expansion: Subjects with urothelial cancer, triple negative breast cancer or cervical cancer with disease progression after at least one prior systemic regimen and no standard treatment options available and considered appropriate in the opinion of the investigator, unless subject refuses standard therapy.
* Measurable disease according to RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, liver, and renal function

Exclusion Criteria:

* Active and uncontrolled central nervous system metastases
* Significant cardiovascular disease
* History of another malignancy other than the one for which the subject is being treated on this study within 3 years
* Receipt of any anticancer or investigational therapy within 5 elimination half-lives or 14 days (whichever is less)
* Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 days prior to the first dose of study drug
* Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Until study completion (estimated 3 years)
Secondary outcomes:
measure: Measurement of maximum plasma concentration (Cmax) of ADRX-0706
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of trough concentration (Ctrough) of ADRX-0706
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of terminal half-life (t1/2) of ADRX-0706
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of systemic clearance (CL) of ADRX-0706
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of volume of distribution at steady state (Vss) of ADRX-0706
timeFrame: Until study completion (estimated 3 years)
measure: Incidence of anti-drug antibodies (ADA)
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of objective response rate (ORR) per RECIST 1.1
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of duration of response (DOR)
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of disease control rate (DCR)
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of progression free survival (PFS)
timeFrame: Until study completion (estimated 3 years)
measure: Measurement of overall survival (OS)
timeFrame: Until study completion (estimated 3 years)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Saint Petersburg
country: United States
facility: Comprehensive Hematology Oncology
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Cancer
state: Michigan
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Hillard
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Nashville
country: United States
facility: Sarah Cannon Cancer Network
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: START San Antonio
state: Texas
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
city: Beijing
country: China
facility: Beijing University Third Hospital
city: Fujian
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Hunan
country: China
facility: Hunan Cancer hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Wuhan Union Hospital
Study officials:
References: