Cervical Cancer, Solid Tumors, Triple Negative Breast Cancer (TNBC), Urothelial Cancer
Conditions
Keywords
urothelial cancer, triple negative breast cancer, cervical cancer, ADC
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.
Interventions
DRUGADRX-0706
Antibody drug conjugate targeting Nectin-4
Sponsors
Adcentrx Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Until study completion (estimated 3 years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of disease control rate (DCR) | Until study completion (estimated 3 years) | Percentage of subjects achieving CR, PR or stable disease (SD) |
| Measurement of maximum plasma concentration (Cmax) of ADRX-0706 | Until study completion (estimated 3 years) | Measured from pharmacokinetic (PK) blood samples |
| Measurement of trough concentration (Ctrough) of ADRX-0706 | Until study completion (estimated 3 years) | Measured from PK blood samples |
| Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706 | Until study completion (estimated 3 years) | Measured from PK blood samples |
| Measurement of terminal half-life (t1/2) of ADRX-0706 | Until study completion (estimated 3 years) | Measured from PK blood samples |
| Measurement of duration of response (DOR) | Until study completion (estimated 3 years) | Time from first response until first evidence of disease progression (PD) or death from any cause |
| Measurement of volume of distribution at steady state (Vss) of ADRX-0706 | Until study completion (estimated 3 years) | Measured from PK blood samples |
| Incidence of anti-drug antibodies (ADA) | Until study completion (estimated 3 years) | Measured from ADA blood samples |
| Measurement of objective response rate (ORR) per RECIST 1.1 | Until study completion (estimated 3 years) | Percentage of subjects achieving complete response (CR) or partial response (PR) |
| Measurement of progression free survival (PFS) | Until study completion (estimated 3 years) | Time from the start of study drug until first evidence of PD or death from any cause |
| Measurement of overall survival (OS) | Until study completion (estimated 3 years) | Time from the start of study drug until death from any cause |
| Measurement of systemic clearance (CL) of ADRX-0706 | Until study completion (estimated 3 years) | Measured from PK blood samples |
Countries
China, United States
Outcome results
None listed