ALT-100 Monoclonal Antibody (mAb) in Bone-Predominant Metastatic Androgen Pathway Modulation Resistant (APMR) Prostate Cancer -- The ALTAR-100 Trial

November 3, 2026 updated by: University of Florida

Aqualung Therapeutics Corporation has developed ALT-100, a humanized murine monoclonal antibody (mAb) that specifically targets and neutralizes extracellular nicotinamide phosphoribosyltransferase (eNAMPT) and prevents activation of a dysregulated proinflammatory signaling cascade.

Pre-clinical and clinical information from acute respiratory distress syndrome and prostate cancer studies show a novel treatment option for the patients with androgen pathway modulator-resistant (APMR) prostate cancer and bone metastases. Secreted eNAMPT drives prostate cancer progression, and a humanized eNAMPT-neutralizing antibody prevented aggressive disease in preclinical models by Sun et al. The anti-fibrotic activity of the eNAMPT-neutralizing antibody acts on type I collagen turnover-the same biology as osteoblastic bone metastasis.

Bone-predominant androgen pathway modulator-resistant (APMR) prostate cancer is a common clinical problem. Treatment options are often limited after progression on ADT and androgen receptor pathway inhibitors. The bone microenvironment itself is still largely untargeted. No eNAMPT-directed therapy has been tested in any oncology population, and no trial has asked whether eNAMPT/toll-like receptor 4 (TLR4) blockade can modify the osseous tumor microenvironment in humans. This trial would test a first-in-class agent aimed at the bone microenvironment rather than at the tumor alone, in a setting where most available therapies offer short-lived benefit.

This study will evaluate the safety, tolerability and efficacy of the use of ALT-100 for treatment of bone-predominant metastatic androgen pathway modulation resistant prostate cancer. The recommended phase 2 dose of ALT-100 for treatment of bone-predominant metastatic androgen pathway modulation resistant prostate cancer will also be determined in the phase 1 portion of this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male, age ≥ 18 years

  • Prostate cancer, histologically confirmed or presumed on the basis of clinical, biochemical, and/or radiographic findings.

  • Metastatic disease confined to bone and lymph nodes, with bone metastases predominant, documented on conventional imaging (CT/MRI and bone scan). Measurable soft tissue disease is not required.

  • Androgen pathway modulation-resistant (APMR) disease per Prostate Cancer Working Group 4 (PCWG4) with progression on at least one prior androgen receptor pathway inhibitor documented as any of the following:

    1. Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL,
    2. Soft tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions,
    3. For PSMA-PET: Two new PSMA-avid lesions, or
    4. Progression of bone disease defined by the appearance of ≥2 new bone lesions on bone scan per PCWG4 criteria

  • Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone analogue, or prior bilateral orchiectomy, with serum testosterone <50 ng/dL

  • ECOG performance status 0-2

  • Life expectancy ≥6 months

  • Adequate organ and marrow function defined as:

    1. ANC ≥1,500/µL
    2. Platelets ≥100,00/µL
    3. Hemoglobin ≥9.0 g/dL without transfusion within 14 days
    4. Total bilirubin ≤1.5 x ULN (≤ 3 x ULN for Gilbert's)
    5. AST and ALT ≤3 x ULN
    6. Creatinine clearance ≥30 mL/min

  • Concurrent bone-modifying agent (including, but not limited to denosumab or bisphosphonates such as zoledronic acid or pamidronate), permitted but not required. If receiving one, it must have been at a stable dose and scheduled for ≥8 weeks before C1D1.

  • Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

  • Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 6 months following the last dose of study drug.

Exclusion Criteria:

  • Visceral metastases, including liver, lung, adrenal, brain or peritoneal disease. Lymph node involvement is permitted
  • Known pure small cell or neuroendocrine prostate carcinoma
  • Radium-223 within 6 months of C1D1
  • External beam radiotherapy to a bone lesion within 4 weeks of C1D1 or radiotherapy planned during the DLT window of 30 days after first dose of ALT-100.
  • Impending skeletal-related event requiring immediate radiotherapy or surgical intervention or untreated spinal cord compression
  • Chemotherapy, investigational therapy, or any systemic anticancer therapy other than ADT within 4 weeks or 5 half-lives of C1D1, whichever is shorter
  • Prior exposure to any extracellular nicotinamide phosphoribosyltransferase (eNAMPT)-directed or toll-like receptor 4 (TLR4)-directed therapeutic agent.
  • Known hypersensitivity to a monoclonal antibody, or prior grade ≥3 infusion-related reaction to a biologic
  • Active infection requiring systemic therapy at C1D1
  • Known HIV infection, or known active hepatitis B or hepatitis C, that is uncontrolled or requires a change in therapy. Testing is not required at screening
  • Cardiovascular or thromboembolic disease that, in the investigator's judgment, is uncontrolled or would place the patient at undue risk on study
  • Chronic systemic immunosuppressive therapy at doses that in the investigator's judgement would place the patient at undue infection risk
  • Active osteonecrosis of the jaw, or invasive dental procedure planned during the DLT window of 30 days after first dose of ALT-100
  • Another malignancy requiring active treatment, except non-melanoma skin cancer or adequately treated in situ disease
  • Any condition that in the investigator's judgement would compromise safety or protocol compliance
  • Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose.
  • Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1 - Dose level 1 - 1.0 mg/kg ALT-100

This is the starting dose for the phase 1 portion of the study.
Biological: ALT-100

Participants will receive either 1.0 mg/kg or 4.0 mg/kg of ALT-100 intravenously once every 28 days for up to 6 treatment cycles while receiving standard of care androgen deprivation therapy. The assigned dose will determined by either a 3 + 3 design (for phase 1) or 1:1 randomization (for phase 2).
Experimental: Phase 1 - Dose Level 2 - 4.0 mg/kg of ALT-100

This is the second dose level that will be tested in the phase 1 portion of the study.
Biological: ALT-100

Participants will receive either 1.0 mg/kg or 4.0 mg/kg of ALT-100 intravenously once every 28 days for up to 6 treatment cycles while receiving standard of care androgen deprivation therapy. The assigned dose will determined by either a 3 + 3 design (for phase 1) or 1:1 randomization (for phase 2).
Experimental: Phase 2 - Recommended phase 2 dose of ALT-100

Participants randomized to this arm will receive the recommended phase 2 dose determined in the phase 1 portion of the study.
Biological: ALT-100

Participants will receive either 1.0 mg/kg or 4.0 mg/kg of ALT-100 intravenously once every 28 days for up to 6 treatment cycles while receiving standard of care androgen deprivation therapy. The assigned dose will determined by either a 3 + 3 design (for phase 1) or 1:1 randomization (for phase 2).
Active Comparator: Phase 2 - Comparator dose of ALT-100

Participants randomized to this arm will receive a comparator dose of ALT-100 that is not the recommended phase 2 dose determined in phase 1.
Biological: ALT-100

Participants will receive either 1.0 mg/kg or 4.0 mg/kg of ALT-100 intravenously once every 28 days for up to 6 treatment cycles while receiving standard of care androgen deprivation therapy. The assigned dose will determined by either a 3 + 3 design (for phase 1) or 1:1 randomization (for phase 2).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of dose limiting toxicities
Time Frame: first 30 days of treatment with ALT-100

Determine the incidence of dose-limiting toxicities during the dose-limiting toxicity evaluation period for participants on the phase 1 portion.
first 30 days of treatment with ALT-100
Percentage of participants who achieve a PSA decrease of at least 30%
Time Frame: After up to 6 months of treatment with ALT-100

Compare the percentage of participants on each arm on the phase 2 portion who achieve a PSA decrease of at least 30%
After up to 6 months of treatment with ALT-100
Percentage of participants who achieve a PSA decrease of at least 50%
Time Frame: After up to 6 months of treatment with ALT-100

Compare the percentage of participants on each arm on the phase 2 portion who achieve a PSA decrease of at least 50%
After up to 6 months of treatment with ALT-100
Radiographic progression-free survival
Time Frame: After up to 6 months of treatment with ALT-100

Compare the radiographic progression-free survival (per Prostate Cancer Working Group 4) of participants on each arm on the phase 2 portion.
After up to 6 months of treatment with ALT-100

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration of ALT-100
Time Frame: At 4 hours after each dose of ALT-100

Determine the maximum plasma concentration of ALT-100 for participants on the Phase 2 portion.
At 4 hours after each dose of ALT-100
Time to reach maximum plasma concentration of ALT-100
Time Frame: At 4 hours after each dose of ALT-100

Determine the time to reach maximum plasma concentration of ALT-100 for participants on the Phase 2 portion.
At 4 hours after each dose of ALT-100
Area under the curve (AUC) up to the last measurable plasma concentration for ALT-100
Time Frame: At 4 hours after each dose of ALT-100

Determine the area under the curve (AUC) up to the last measurable plasma concentration for ALT-100 for participants on the Phase 2 portion.
At 4 hours after each dose of ALT-100
Area under the curve (AUC) over the dosing interval for ALT-100
Time Frame: Over the 4 weeks between doses of ALT-100

Determine the area under the curve (AUC) over the dosing interval for ALT-100 for participants on the Phase 2 portion.
Over the 4 weeks between doses of ALT-100
Half-life for ALT-100
Time Frame: At 4 hours after each dose of ALT-100

Determine the half-life for ALT-100 for participants on the Phase 2 portion.
At 4 hours after each dose of ALT-100
Trough plasma concentration for ALT-100
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Determine the trough plasma concentration for ALT-100 for participants on the Phase 2 portion.
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Average plasma concentration during a dosing interval for ALT-100
Time Frame: Over the 4 weeks between doses of ALT-100

Determine the average plasma concentration during a dosing interval for ALT-100 for participants on the Phase 2 portion.
Over the 4 weeks between doses of ALT-100
Plasma concentration of eNAMPT
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of eNAMPT
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of IL-6
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of IL-6
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of IL-8
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of IL-8
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of TNF-a
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of TNF-a
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of IL-1b
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of IL-1b
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of IL-1RA
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of IL-1RA
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of Ang2
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of Ang2
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of VEGF
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of VEGF
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of BMP-2
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of BMP-2
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of PDGF-BB
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of PDGF-BB
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of osteopontin
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of osteopontin
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of osteocalcin
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of osteocalcin
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of bALP
Time Frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Measure the plasma concentration of bALP
Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Araujo, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UF-GU-015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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