Solid TumorsPhase 1NCT06710379
A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
A Phase 1 study testing ADRX-0405 in people with Solid Tumors, run by Adcentrx Therapeutics at 8 sites in United States.
Trial summary
The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0405 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
- What is being tested?
- ADRX-0405
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Dec 2024to 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 metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC).
- Phase 1b Dose Expansion: Subjects with histologically confirmed prostate adenocarcinoma that is confirmed to be castration resistant (i.e., serum testosterone < 50 ng/dL [< 2.0 nM]) and that is intolerant/resistant to standard of care (SOC) therapies.
- Measurable disease according to RECIST version 1.1 or evaluable disease per PCWG3 for subjects with prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in 1b
- 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); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer
- History of (non-infectious) ILD/pneumonitis that required steroids within 2 years of study enrollment, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
NEXT Austin
Austin, Texas, 78758
Suhrutha Bushan, (737) 610-5202, sbushan@nextoncology.com
- Recruiting
City of Hope
Duarte, California, 91010
Erin Morones, 626-218-9708 ext. 89708, emorones@coh.org
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Blake Patterson, (703) 783-4505, bpatterson@nextoncology.com
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Julie Burns, 616-954-5559, julie.burns@startresearch.com
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jordi Rodon Ahnert, MD, PhD, 713-792-5603, jrodon@mdanderson.org
- Recruiting
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
Patricia Beckman, RN, 612-624-2620, ccinfo@umn.edu
- Recruiting
UCLA
Santa Monica, California, 90404
Rosa Vazquez, 310-633-8400 ext. 16049, ravazquez@mednet.ucla.edu
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
Marie Asay, 801-907-4770, marie.asay@startresearch.com
About this study
Official title: A Phase 1a/b Study of ADRX-0405 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-0405 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-0405 to evaluate initial safety and tolerability in patients with select advanced solid tumors [including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC)], 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-0405 in subjects with previously treated metastatic castration resistant prostate cancer (mCRPC).
- Conditions
- Solid Tumors
- Being tested
- ADRX-0405
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRX-0405Drug
Antibody Drug Conjugate targeting STEAP1
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Increasing doses of ADRX-0405 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-0405 |
| Phase 1b Dose Expansion | Experimental | ADRX-0405 will be initially administered at the dose recommended from the Phase 1a part in subjects with previously treated mCRPC. Receives: Drug: ADRX-0405 |
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 2 years)
Secondary outcomes (14)
Measurement of End of Infusion or observed maximum blood concentration (Ceoi orCmax) of ADRX-0405
Measured from pharmacokinetic (PK) blood samples
Measured: Until study completion (estimated 2 years)
Measurement of trough concentration (Ctrough) of ADRX-0405
Measured from PK blood samples
Measured: Until study completion (estimated 2 years)
Measurement of area under the blood concentration-time curve (AUC) of ADRX-0405
Measured from PK blood samples
Measured: Until study completion (estimated 2 years)
Measurement of partial area under the concentration-time curve after first dose (AUC0-21) of ADRX-0405 and as appropriate
Measured from PK blood samples
Measured: Until study completion (estimated 2 years)
Measurement of terminal or apparent terminal half-life (t1/2) of ADRX-0405
Measured from PK blood samples
Measured: Until study completion (estimated 2 years)
Measurement of systemic clearance (CL) and volume of distribution at steady state (Vss) as appropriate of ADRX-0405
Measured from PK blood samples
Measured: Until study completion (estimated 2 years)
Incidence of anti-drug antibody (ADA) to ADRX-0405
Measured from ADA blood samples
Measured: Until study completion (estimated 2 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 2 years)
ORR per Prostate Cancer Working Group 3 (PCWG3)
Percentage of subjects achieving complete response (CR) or partial response (PR)
Measured: Until study completion (estimated 2 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 2 years)
Measurement of disease control rate (DCR)
Percentage of subjects achieving CR, PR or stable disease (SD)
Measured: Until study completion (estimated 2 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 2 years)
Measurement of radiographic progression free survival (rPFS)
Time from the start of study drug until first radiographic documentation of PD, or death from any cause, whichever comes first
Measured: Until study completion (estimated 2 years)
Measurement of overall survival (OS)
Time from the start of study drug until death from any cause
Measured: Until study completion (estimated 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start30 Dec 2024
- Primary completionJul 2026 (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
- 68 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
- NCT06710379
- Sponsor's protocol ID
- ADRX-0405-001
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/b Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06710379
- Acronym / sponsor ID
- ADRX-0405-001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Adcentrx TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Nov 2024 (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-0405 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-0405 to evaluate initial safety and tolerability in patients with select advanced solid tumors [including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC)], 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-0405 in subjects with previously treated metastatic castration resistant prostate cancer (mCRPC).
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-0405Increasing doses of ADRX-0405 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-0405ADRX-0405 will be initially administered at the dose recommended from the Phase 1a part in subjects with previously treated mCRPC. |
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 metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC).
- Phase 1b Dose Expansion: Subjects with histologically confirmed prostate adenocarcinoma that is confirmed to be castration resistant (i.e., serum testosterone < 50 ng/dL [< 2.0 nM]) and that is intolerant/resistant to standard of care (SOC) therapies.
- Measurable disease according to RECIST version 1.1 or evaluable disease per PCWG3 for subjects with prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in 1b
- 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); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer
- History of (non-infectious) ILD/pneumonitis that required steroids within 2 years of study enrollment, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
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-0405Antibody Drug Conjugate targeting STEAP1 | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion |
Primary outcome
Incidence of adverse events
Time frame: Until study completion (estimated 2 years)
14 secondary outcomes
Measurement of End of Infusion or observed maximum blood concentration (Ceoi orCmax) of ADRX-0405
Time frame: Until study completion (estimated 2 years)
Measurement of trough concentration (Ctrough) of ADRX-0405
Time frame: Until study completion (estimated 2 years)
Measurement of area under the blood concentration-time curve (AUC) of ADRX-0405
Time frame: Until study completion (estimated 2 years)
Measurement of partial area under the concentration-time curve after first dose (AUC0-21) of ADRX-0405 and as appropriate
Time frame: Until study completion (estimated 2 years)
Measurement of terminal or apparent terminal half-life (t1/2) of ADRX-0405
Time frame: Until study completion (estimated 2 years)
Measurement of systemic clearance (CL) and volume of distribution at steady state (Vss) as appropriate of ADRX-0405
Time frame: Until study completion (estimated 2 years)
Incidence of anti-drug antibody (ADA) to ADRX-0405
Time frame: Until study completion (estimated 2 years)
Measurement of objective response rate (ORR) per RECIST 1.1
Time frame: Until study completion (estimated 2 years)
ORR per Prostate Cancer Working Group 3 (PCWG3)
Time frame: Until study completion (estimated 2 years)
Measurement of duration of response (DOR)
Time frame: Until study completion (estimated 2 years)
Measurement of disease control rate (DCR)
Time frame: Until study completion (estimated 2 years)
Measurement of progression free survival (PFS)
Time frame: Until study completion (estimated 2 years)
Measurement of radiographic progression free survival (rPFS)
Time frame: Until study completion (estimated 2 years)
Measurement of overall survival (OS)
Time frame: Until study completion (estimated 2 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 9 Apr 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADRX-0405 in people with Solid Tumors, run by Adcentrx Therapeutics at 8 sites in United States.
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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Contact Adcentrx Therapeutics (858-428-9502, clinicaltrials@adcentrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Until study completion (estimated 2 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 9 Apr 2025.