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ALT-100 in Bone-Predominant Metastatic APMR Prostate Cancer (ALTAR-100)

NCT07917390Phase 2

Key facts

Status: Not yet recruiting
Start: Jan 2027
Primary completion: Aug 2028
Sponsor: University of Florida

Drugs: enamptcumab
Conditions: prostate cancer (PCa)

Overview

Phase 2, randomised, open-label trial of enamptcumab in prostate cancer (PCa) (4 arms), sponsored by University of Florida. Primary endpoints: Incidence of dose limiting toxicities at 30 days, Percentage of participants who achieve a PSA decrease of at least 30% at 6 months and 2 more. Planned start Jan 2027; status: not yet recruiting.

Design

4 arms

Study design: RandomizedOpen-label

Phase 1 - Dose level 1 - 1.0 mg/kg ALT-100
1.0 mg/kg ALT-100 IV once every 28 days + ADT
Phase 1 - Dose Level 2 - 4.0 mg/kg of ALT-100
4.0 mg/kg ALT-100 IV once every 28 days + ADT
Phase 2 - Recommended phase 2 dose of ALT-100
RP2D ALT-100 IV once every 28 days + ADT
Phase 2 - Comparator dose of ALT-100
Comparator dose ALT-100 IV once every 28 days + ADT

Who it enrols

Men >= 18 years with bone-predominant metastatic androgen pathway modulation-resistant (APMR) prostate cancer, progressing on at least one prior ARPI, with ongoing ADT, ECOG 0-2, and adequate organ function. Excludes visceral metastases, pure small cell/neuroendocrine carcinoma, and recent Radium-223 or radiotherapy.

Endpoints

Primary

Incidence of dose limiting toxicities30 days
Percentage of participants who achieve a PSA decrease of at least 30%6 months
Percentage of participants who achieve a PSA decrease of at least 50%6 months
Radiographic progression-free survival6 months

Secondary

Maximum plasma concentration of ALT-1004 hours post-dose
Time to reach maximum plasma concentration of ALT-1004 hours post-dose
Area under the curve4 weeks
Half-life for ALT-1004 hours post-dose
Trough plasma concentration for ALT-100Day 1 of each 28-day cycle
Average plasma concentration during a dosing interval for ALT-1004 weeks
Plasma concentration of biomarkersDay 1 of each 28-day cycle

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