ALT-100 Monoclonal Antibody (mAb) in Bone-Predominant Metastatic Androgen Pathway Modulation Resistant (APMR) Prostate Cancer -- The ALTAR-100 Trial
NCT07917390, Phase 1, Phase 2, Not yet recruiting, University of Florida
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | ALT-100 Monoclonal Antibody (mAb) in Bone-Predominant Metastatic Androgen Pathway Modulation Resistant (APMR) Prostate Cancer -- The ALTAR-100 Trial | ClinicalTrials.gov |
| NCT number | NCT07917390 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 42 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Florida | ClinicalTrials.gov |
| Conditions | Prostate Cancer Metastatic to Bone | ClinicalTrials.gov |
| Interventions | ALT-100 | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of dose limiting toxicities | 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. | ClinicalTrials.gov |
| Primary | Percentage of participants who achieve a PSA decrease of at least 30% | 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% | ClinicalTrials.gov |
| Primary | Percentage of participants who achieve a PSA decrease of at least 50% | 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% | ClinicalTrials.gov |
| Primary | Radiographic progression-free survival | 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. | ClinicalTrials.gov |
| Secondary | Maximum plasma concentration of ALT-100 | At 4 hours after each dose of ALT-100 | Determine the maximum plasma concentration of ALT-100 for participants on the Phase 2 portion. | ClinicalTrials.gov |
| Secondary | Time to reach maximum plasma concentration of ALT-100 | 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. | ClinicalTrials.gov |
| Secondary | Area under the curve (AUC) up to the last measurable plasma concentration for ALT-100 | 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. | ClinicalTrials.gov |
| Secondary | Area under the curve (AUC) over the dosing interval for ALT-100 | 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. | ClinicalTrials.gov |
| Secondary | Half-life for ALT-100 | At 4 hours after each dose of ALT-100 | Determine the half-life for ALT-100 for participants on the Phase 2 portion. | ClinicalTrials.gov |
| Secondary | Trough plasma concentration for ALT-100 | 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. | ClinicalTrials.gov |
| Secondary | Average plasma concentration during a dosing interval for ALT-100 | 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. | ClinicalTrials.gov |
| Secondary | Plasma concentration of eNAMPT | Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days) | Measure the plasma concentration of eNAMPT | ClinicalTrials.gov |
| Secondary | Plasma concentration of IL-6 | Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days) | Measure the plasma concentration of IL-6 | ClinicalTrials.gov |
| Secondary | Plasma concentration of IL-8 | Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days) | Measure the plasma concentration of IL-8 | ClinicalTrials.gov |
| Secondary | Plasma concentration of TNF-a | Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days) | Measure the plasma concentration of TNF-a | ClinicalTrials.gov |
| Secondary | Plasma concentration of IL-1b | Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days) | Measure the plasma concentration of IL-1b | ClinicalTrials.gov |
| Secondary | Plasma concentration of IL-1RA | Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days) | Measure the plasma concentration of IL-1RA | ClinicalTrials.gov |
| Secondary | Plasma concentration of Ang2 | Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days) | Measure the plasma concentration of Ang2 | ClinicalTrials.gov |
| Secondary | Plasma concentration of VEGF | Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days) | Measure the plasma concentration of VEGF | ClinicalTrials.gov |
| Secondary | Plasma concentration of BMP-2 | Prior to dosing of ALT-100 on day 1 of each cycle (each cycle is 28 days) | Measure the plasma concentration of BMP-2 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)