A Phase 1/2 interventional study of ALT-100 in Prostate Cancer Metastatic to Bone, sponsored by University of Florida. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Florida · Phase 1/2, Interventional, and Treatment
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 42 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Adequate organ and marrow function defined as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is the starting dose for the phase 1 portion of the study.
Biological: ALT-100
This is the second dose level that will be tested in the phase 1 portion of the study.
Biological: 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 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).
Incidence of dose limiting toxicities
Determine the incidence of dose-limiting toxicities during the dose-limiting toxicity evaluation period for participants on the phase 1 portion.
Time frame: first 30 days of treatment with ALT-100
Percentage of participants who achieve a PSA decrease of at least 30%
Compare the percentage of participants on each arm on the phase 2 portion who achieve a PSA decrease of at least 30%
Time frame: After up to 6 months of treatment with ALT-100
Percentage of participants who achieve a PSA decrease of at least 50%
Compare the percentage of participants on each arm on the phase 2 portion who achieve a PSA decrease of at least 50%
Time frame: After up to 6 months of treatment with ALT-100
Radiographic progression-free survival
Compare the radiographic progression-free survival (per Prostate Cancer Working Group 4) of participants on each arm on the phase 2 portion.
Time frame: After up to 6 months of treatment with ALT-100
Maximum plasma concentration of ALT-100
Determine the maximum plasma concentration of ALT-100 for participants on the Phase 2 portion.
Time frame: At 4 hours after each dose of ALT-100
Time to reach maximum plasma concentration of ALT-100
Determine the time to reach maximum plasma concentration of ALT-100 for participants on the Phase 2 portion.
Time frame: At 4 hours after each dose of ALT-100
Area under the curve (AUC) up to the last measurable plasma concentration for 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.
Time frame: At 4 hours after each dose of ALT-100
Area under the curve (AUC) over the dosing interval for ALT-100
Determine the area under the curve (AUC) over the dosing interval for ALT-100 for participants on the Phase 2 portion.
Time frame: Over the 4 weeks between doses of ALT-100
Half-life for ALT-100
Determine the half-life for ALT-100 for participants on the Phase 2 portion.
Time frame: At 4 hours after each dose of ALT-100
Trough plasma concentration for ALT-100
Determine the trough plasma concentration for ALT-100 for participants on the Phase 2 portion.
Time frame: 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
Determine the average plasma concentration during a dosing interval for ALT-100 for participants on the Phase 2 portion.
Time frame: Over the 4 weeks between doses of ALT-100
Plasma concentration of eNAMPT
Measure the plasma concentration of eNAMPT
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of IL-6
Measure the plasma concentration of IL-6
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of IL-8
Measure the plasma concentration of IL-8
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of TNF-a
Measure the plasma concentration of TNF-a
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of IL-1b
Measure the plasma concentration of IL-1b
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of IL-1RA
Measure the plasma concentration of IL-1RA
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of Ang2
Measure the plasma concentration of Ang2
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of VEGF
Measure the plasma concentration of VEGF
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of BMP-2
Measure the plasma concentration of BMP-2
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of PDGF-BB
Measure the plasma concentration of PDGF-BB
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of osteopontin
Measure the plasma concentration of osteopontin
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of osteocalcin
Measure the plasma concentration of osteocalcin
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Plasma concentration of bALP
Measure the plasma concentration of bALP
Time frame: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
No study locations are listed for this record.
Start is estimated for Jan 2027; primary completion for Aug 2028, 19 months later.
Of 114 non-industry phase 1/2 interventional studies under Prostatic Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 85. This study's planned 19 months is below that.
Counting every sponsor, half of 210 studies reached it within 61 months; a quarter within 30 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: ALT-100