Solid TumorsPhase 1NCT06036121
A Study of ADRX-0706 in Select Advanced Solid Tumors
A Phase 1 study testing ADRX-0706 in people with Solid Tumors and Triple Negative Breast Cancer (TNBC), run by Adcentrx Therapeutics at 21 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Triple Negative Breast Cancer (TNBC), Urothelial Cancer
- What is being tested?
- ADRX-0706
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 26 Sep 2023to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States13 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Cancer
Detroit, Michigan, 48202
START Midwest
Grand Rapids, Michigan, 49546
The Ohio State University Wexner Medical Center
Hilliard, Ohio, 43026
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA
Los Angeles, California, 90404
Sarah Cannon Cancer Network
Nashville, Tennessee, 37203
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
START San Antonio
San Antonio, Texas, 78229
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
Moffitt Cancer Center
Tampa, Florida, 33610
START Mountain Region
West Valley City, Utah, 84119
China8 sites
Beijing University Third Hospital
Beijing
Fujian Cancer Hospital
Fujian
Sun Yat-sen University Cancer Center
Guangzhou
Hunan Cancer hospital
Hunan
Shandong Cancer Hospital
Jinan
Shanghai East Hospital
Shanghai
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Wuhan Union Hospital
Wuhan
About this study
Official title: A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors
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.
Read the 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.
- Being tested
- ADRX-0706
- Keywords
- urothelial cancer, triple negative breast cancer, cervical cancer, ADC
- Medical subject headings
- Triple Negative Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRX-0706Drug
Antibody drug conjugate targeting Nectin-4
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Increasing doses of ADRX-0706 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part. Receives: Drug: ADRX-0706 |
| Phase 1b Dose Expansion | Experimental | ADRX-0706 will be initially administered to patients at the dose recommended from the Phase 1a part in 3 disease-specific cohorts: urothelial cancer, triple negative breast cancer, and cervical cancer. Receives: Drug: ADRX-0706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Until study completion (estimated 3 years)
Secondary outcomes (12)
Measurement of maximum plasma concentration (Cmax) of ADRX-0706
Measured from pharmacokinetic (PK) blood samples
Measured: Until study completion (estimated 3 years)
Measurement of trough concentration (Ctrough) of ADRX-0706
Measured from PK blood samples
Measured: Until study completion (estimated 3 years)
Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706
Measured from PK blood samples
Measured: Until study completion (estimated 3 years)
Measurement of terminal half-life (t1/2) of ADRX-0706
Measured from PK blood samples
Measured: Until study completion (estimated 3 years)
Measurement of systemic clearance (CL) of ADRX-0706
Measured from PK blood samples
Measured: Until study completion (estimated 3 years)
Measurement of volume of distribution at steady state (Vss) of ADRX-0706
Measured from PK blood samples
Measured: Until study completion (estimated 3 years)
Incidence of anti-drug antibodies (ADA)
Measured from ADA blood samples
Measured: Until study completion (estimated 3 years)
Measurement of objective response rate (ORR) per RECIST 1.1
Percentage of subjects achieving complete response (CR) or partial response (PR)
Measured: Until study completion (estimated 3 years)
Measurement of duration of response (DOR)
Time from first response until first evidence of disease progression (PD) or death from any cause
Measured: Until study completion (estimated 3 years)
Measurement of disease control rate (DCR)
Percentage of subjects achieving CR, PR or stable disease (SD)
Measured: Until study completion (estimated 3 years)
Measurement of progression free survival (PFS)
Time from the start of study drug until first evidence of PD or death from any cause
Measured: Until study completion (estimated 3 years)
Measurement of overall survival (OS)
Time from the start of study drug until death from any cause
Measured: Until study completion (estimated 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start26 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adcentrx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036121
- Sponsor's protocol ID
- ADRX-0706-001
- Status last verified
- Aug 2025
- First submitted
- 6 Sep 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06036121
- Acronym / sponsor ID
- ADRX-0706-001
- Keywords
- urothelial cancer, triple negative breast cancer, cervical cancer, ADC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Adcentrx TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: ADRX-0706Increasing doses of ADRX-0706 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part. |
| Phase 1b Dose Expansion | Experimental | Drug: ADRX-0706ADRX-0706 will be initially administered to patients at the dose recommended from the Phase 1a part in 3 disease-specific cohorts: urothelial cancer, triple negative breast cancer, and cervical cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADRX-0706Antibody drug conjugate targeting Nectin-4 | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion |
Primary outcome
Incidence of adverse events
Time frame: Until study completion (estimated 3 years)
12 secondary outcomes
Measurement of maximum plasma concentration (Cmax) of ADRX-0706
Time frame: Until study completion (estimated 3 years)
Measurement of trough concentration (Ctrough) of ADRX-0706
Time frame: Until study completion (estimated 3 years)
Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706
Time frame: Until study completion (estimated 3 years)
Measurement of terminal half-life (t1/2) of ADRX-0706
Time frame: Until study completion (estimated 3 years)
Measurement of systemic clearance (CL) of ADRX-0706
Time frame: Until study completion (estimated 3 years)
Measurement of volume of distribution at steady state (Vss) of ADRX-0706
Time frame: Until study completion (estimated 3 years)
Incidence of anti-drug antibodies (ADA)
Time frame: Until study completion (estimated 3 years)
Measurement of objective response rate (ORR) per RECIST 1.1
Time frame: Until study completion (estimated 3 years)
Measurement of duration of response (DOR)
Time frame: Until study completion (estimated 3 years)
Measurement of disease control rate (DCR)
Time frame: Until study completion (estimated 3 years)
Measurement of progression free survival (PFS)
Time frame: Until study completion (estimated 3 years)
Measurement of overall survival (OS)
Time frame: Until study completion (estimated 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADRX-0706 in people with Solid Tumors and Triple Negative Breast Cancer (TNBC), run by Adcentrx Therapeutics at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Until study completion (estimated 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.