Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)

ConditionAdenoid Cystic Carcinoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

Phase II open label study designed to evaluate the efficacy and safety of P-Sam in patients with aggressive, solid, NOTCH mutant or p63 low (B7-H4 high) R/M ACC-I patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥18 years with histology-proven advanced, or R/M ACC.

Evidence of locally advanced disease not amenable to curative intent surgery or radiotherapy, or recurrent/metastatic disease

Measurable disease per RECIST 1.1

Performance status ECOG of 0 or 1

Disqualifiers

Nitrosourea or mitomycin C

Any investigational agents or study drugs from a previous clinical study

Any other anticancer treatment

Radiotherapy

Trial design

Design model

Single group

Treatments tested in this trial

P-Sam
Drug
Given by IV

Treatment groups

28 Participants

are divided into 1 treatment group

Group A: P-SamExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety and Adverse Events (AEs)

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

Time frame

Through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov

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