Bladder CancerPhase 1NCT05524545
A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)
A Phase 1 study testing Evorpacept and Enfortumab Vedotin in people with Bladder Cancer and Urothelial Carcinoma, run by ALX Oncology Inc. at 8 sites in United States.
Trial summary
AT148007 is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma
- What is being tested?
- Evorpacept and Enfortumab Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesUnited States
- Study dates
- 2 Nov 2022to 27 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma.
- Must have received prior treatment with an immune checkpoint inhibitor (CPI).
- Subjects must have received prior treatment with platinum-containing chemotherapy.
- Subjects must have had progression or recurrence of urothelial cancer.
- Subjects must have measurable disease according to RECIST (Version 1.1).
- Adequate bone marrow function.
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- Adequate renal function.
- Adequate liver function.
- Adequate Eastern Cooperative Oncology Group (ECOG) performance status.
Who cannot join
- Preexisting sensory or motor neuropathy Grade ≥2.
- Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
- Prior treatment with enfortumab vedotin or other monomethylauristatin (MMAE)-based antibody-drug conjugate (ADCs)
- Prior treatment with any anti-CD47 or anti-signal regulatory protein-α (SIRPα) agent.
- Known active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated.
- History of uncontrolled diabetes mellitus within 3 months of the first dose of study drug.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Massachusett's General
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
UT Southwestern
Dallas, Texas, 75390
West Clinic
Germantown, Tennessee, 38138
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Oregon Health & Science University
Portland, Oregon, 97239
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)
AT148007 is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Being tested
- Evorpacept, Enfortumab Vedotin
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvorpaceptDrug
Also called ALX148
Fusion protein that blocks CD47-SIRPalpha pathway
Enfortumab VedotinDrug
Also called PADCEV
Nectin-4 directed antibody and microtubule inhibitor conjugate
| Study group | Role | What they receive |
|---|---|---|
| Evorpacept (ALX148) + Enfortumab Vedotin | Experimental | Phase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks.
Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle. Receives: Drug: Evorpacept; Drug: Enfortumab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Cycle Dose limiting toxicities (DLTs)
Measured: Up to 28 days
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0)), timing, seriousness, and relationship to study therapy
Measured: Up to 24 months
Phase 1: Recommended Phase 2 Dose (RP2D)
To identify the RP2D of ALX148 in combination with enfortumab vedotin
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start2 Nov 2022
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALX Oncology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524545
- Sponsor's protocol ID
- ASPEN-07
- Status last verified
- Jul 2025
- First submitted
- 30 Aug 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)
- ClinicalTrials.gov ID
- NCT05524545
- Acronym / sponsor ID
- ASPEN-07
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ALX Oncology Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 1 Sep 2022 (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.
AT148007 is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evorpacept (ALX148) + Enfortumab Vedotin | Experimental | Drug: Evorpacept, Drug: Enfortumab VedotinPhase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks. Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma.
- Must have received prior treatment with an immune checkpoint inhibitor (CPI).
- Subjects must have received prior treatment with platinum-containing chemotherapy.
- Subjects must have had progression or recurrence of urothelial cancer.
- Subjects must have measurable disease according to RECIST (Version 1.1).
Key exclusion criteria (6 listed)
- Preexisting sensory or motor neuropathy Grade ≥2.
- Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
- Prior treatment with enfortumab vedotin or other monomethylauristatin (MMAE)-based antibody-drug conjugate (ADCs)
- Prior treatment with any anti-CD47 or anti-signal regulatory protein-α (SIRPα) agent.
- Known active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated.
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 |
|---|---|---|
| EvorpaceptAlso: ALX148Fusion protein that blocks CD47-SIRPalpha pathway | Drug | Evorpacept (ALX148) + Enfortumab Vedotin |
| Enfortumab VedotinAlso: PADCEVNectin-4 directed antibody and microtubule inhibitor conjugate | Drug | Evorpacept (ALX148) + Enfortumab Vedotin |
Primary outcome
First Cycle Dose limiting toxicities (DLTs)
Time frame: Up to 28 days
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0)), timing, seriousness, and relationship to study therapy
Time frame: Up to 24 months
Phase 1: Recommended Phase 2 Dose (RP2D)
Time frame: Up to 15 months
To identify the RP2D of ALX148 in combination with enfortumab vedotin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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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.
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 Evorpacept and Enfortumab Vedotin in people with Bladder Cancer and Urothelial Carcinoma, run by ALX Oncology Inc. 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 9 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: finished, as of the sponsor's last update on 25 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
First Cycle Dose limiting toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. 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 25 Jul 2025.