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P-Sam

Phase 2

Adenoid Cystic Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Sep 18, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

P-Sam · 1 trial · 1 indication

Phase 2 1
NCT07162480Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)Adenoid Cystic Carcinoma
RECRUITING28 Analytics
PHASE2RECRUITING
Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)
Adenoid Cystic Carcinoma
NCT0716248028
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Study Endpoints

Primary Endpoints

Safety and Adverse Events (AEs)
Through study completion; an average of 1 year

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
P-SamEXPERIMENTALParticipants will receive P-Sam at 2.4 mg/kg intravenously on D1 of a 21-day treatment cycle

Interventions

NameTypeDescription
P-SamDRUGGiven by IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients ≥18 years with histology-proven advanced, or R/M ACC. 2. Evidence of locally advanced disease not amenable to curative intent surgery or radiotherapy, or recurrent/metastatic disease 3. ACC-I subtype defined by at least one of the following: 1. Presence of an act...

Countries:United States
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