Prostate Cancer Metastatic to BonePhase 1/2NCT07917390
ALT-100 Monoclonal Antibody (mAb) in Bone-Predominant Metastatic Androgen Pathway Modulation Resistant (APMR) Prostate Cancer -- The ALTAR-100 Trial
A Phase 1/2 study testing ALT-100 in people with Prostate Cancer Metastatic to Bone, run by University of Florida.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic to Bone
- What is being tested?
- ALT-100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Aug 2028
- Phase
- Phase 1/2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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,
- 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,
Show all 21Show fewer
- For PSMA-PET: Two new PSMA-avid lesions, or
- 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:
- ANC ≥1,500/µL
- Platelets ≥100,00/µL
- Hemoglobin ≥9.0 g/dL without transfusion within 14 days
- Total bilirubin ≤1.5 x ULN (≤ 3 x ULN for Gilbert's)
- AST and ALT ≤3 x ULN
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Prostate Cancer Metastatic to Bone
- Being tested
- ALT-100
- Keywords
- Bone-predominant androgen pathway modulator-resistant (APMR) prostate cancer, monoclonal antibody
- Medical subject headings
- AMR Syndrome, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALT-100Biological
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).
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - Dose level 1 - 1.0 mg/kg ALT-100 | Experimental | This is the starting dose for the phase 1 portion of the study. Receives: Biological: ALT-100 |
| Phase 1 - Dose Level 2 - 4.0 mg/kg of ALT-100 | Experimental | This is the second dose level that will be tested in the phase 1 portion of the study. Receives: Biological: ALT-100 |
| Phase 2 - Recommended phase 2 dose of ALT-100 | Experimental | Participants randomized to this arm will receive the recommended phase 2 dose determined in the phase 1 portion of the study. Receives: Biological: ALT-100 |
| Phase 2 - Comparator dose of ALT-100 | Active comparator | 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. Receives: Biological: ALT-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%
Measured: 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%
Measured: 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.
Measured: After up to 6 months of treatment with ALT-100
Secondary outcomes (20)
Maximum plasma concentration of ALT-100
Determine the maximum plasma concentration of ALT-100 for participants on the Phase 2 portion.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over the 4 weeks between doses of ALT-100
Plasma concentration of eNAMPT
Measure the plasma concentration of eNAMPT
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic to BoneStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Araujo, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917390
- Sponsor's protocol ID
- UF-GU-015
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALT-100 Monoclonal Antibody (mAb) in Bone-Predominant Metastatic Androgen Pathway Modulation Resistant (APMR) Prostate Cancer -- The ALTAR-100 Trial
- ClinicalTrials.gov ID
- NCT07917390
- Acronym / sponsor ID
- UF-GU-015
- Conditions
- Prostate Cancer Metastatic to Bone
- Keywords
- Bone-predominant androgen pathway modulator-resistant (APMR) prostate cancer, monoclonal antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 4 Nov 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - Dose level 1 - 1.0 mg/kg ALT-100 | Experimental | Biological: ALT-100This is the starting dose for the phase 1 portion of the study. |
| Phase 1 - Dose Level 2 - 4.0 mg/kg of ALT-100 | Experimental | Biological: ALT-100This is the second dose level that will be tested in the phase 1 portion of the study. |
| Phase 2 - Recommended phase 2 dose of ALT-100 | Experimental | Biological: ALT-100Participants randomized to this arm will receive the recommended phase 2 dose determined in the phase 1 portion of the study. |
| Phase 2 - Comparator dose of ALT-100 | Active comparator | Biological: ALT-100Participants randomized to this arm will receive a comparator dose of ALT-100 that is not the recommended phase 2 dose determined in phase 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone analogue, or prior bilateral orchiectomy, with serum testosterone <50 ng/dL
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| ALT-100Participants 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). | Biological | Phase 1 - Dose Level 2 - 4.0 mg/kg of ALT-100, Phase 1 - Dose level 1 - 1.0 mg/kg ALT-100, Phase 2 - Comparator dose of ALT-100, Phase 2 - Recommended phase 2 dose of ALT-100 |
Primary outcome
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.
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%
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%
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.
20 secondary outcomes
Maximum plasma concentration of ALT-100
Time frame: 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
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
Area under the curve (AUC) over the dosing interval for ALT-100
Time frame: 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
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)
Average plasma concentration during a dosing interval for ALT-100
Time frame: 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)
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
Time frame: 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)
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
Time frame: 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)
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
Time frame: 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)
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
Time frame: 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)
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 4 Nov 2026.
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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.
Daniel Araujo, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALT-100 in people with Prostate Cancer Metastatic to Bone, run by University of Florida.
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 21 inclusion and 17 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Alexandra Leggett (352-273-9785, agmueller@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (time frame: first 30 days of treatment with ALT-100). The study lists 4 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 4 Nov 2026.