Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alyssum Therapeutics
Study ID
NCT06234098
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AT-1965 Liposome Injection — DRUG
    AT-1965 Liposome Injection administered intravenously once weekly for the first 3 weeks (Days 1, 8 and 15) of a 4 week cycle.

Study Details

This is a first-in-human, multicenter, open-label, dose escalation and dose expansion Phase 1/2 study to determine the MTD and/or the recommended Phase 2 dose (RP2D) and to characterize DLTs of AT-1965 as well as to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of AT-1965 in patients with advanced, refractory or recurrent solid tumors (nonresectable and/or metastatic) including mTNBC.

Key Dates

Start date
Feb 13, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
85 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AT-1965 Liposome Injection

Primary Outcome Measure

Dose Limiting Toxicity (DLT) according to CTCAE version 5.0 in Part A - Dose Escalation Phase [ Time Frame: Dose limiting toxicities will be evaluated during the first treatment cycle (28 days) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
CBCC Global Research Site 001ScottsdaleArizona85258-
CBCC Global Research Site 005BakersfieldCalifornia93309-
CBCC Global Research Site 007El SegundoCalifornia90245-
CBCC Global Research Site 008Santa MonicaCalifornia90403-
CBCC Global Research Site 003StanfordCalifornia94305-
CBCC Global Research Site 002PortlandOregon97239-
CBCC Global Research Site 006DallasTexas75230-

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CBCC Global Research· Scottsdale, AZCBCC Global Research· Bakersfield, CACBCC Global Research· El Segundo, CACBCC Global Research· Santa Monica, CACBCC Global Research· Stanford, CACBCC Global Research· Portland, OR

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