Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggre… (NCT07162480) | Clinical Trial Compass
RecruitingPhase 2
Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)
United States28 participantsStarted 2026-04-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. ACC-I subtype defined by at least one of the following:
✓. Presence of an activating NOTCH mutation per in-house or any CLIA-certified or commercially available next-generation sequencing assay
✓. Solid histology and clinical course characterized by \< 3 years from diagnosis to initial recurrence or progression or de novo metastatic disease with extra-pulmonary metastasis
✓. Negative TP63 tumor expression by IHC (\<10% of tumor cells)
✓. Measurable disease per RECIST 1.1
✓. Performance status ECOG of 0 or 1
Exclusion criteria
✕. Treatment with any of the following as detailed below in Table 2:
✕. Unresolved toxicities of Grade ≥ 2 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE version 5.0) from prior therapy (excluding vitiligo, alopecia, endocrine disorders that are controlled with replacement hormone therapy, and lymphopenia unless it is accompanied by clinical signs of infection or the indication for prophylaxis with antibiotic/antiviral/antifungal therapy). Participants with chemotherapy-induced Grade 2 neuropathy may be eligible at discretion of the Investigator.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
. Active infection, including tuberculosis, SARS-CoV-2, and known infections with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency. Participants with a past or resolved HBV/HCV infection are eligible if all the following criteria are met:
✕. Negative for HBsAg and positive for total hepatitis B core antibody (anti-HBc) or Positive for HBsAg, but for \> 6 months have had normal transaminases and HBV DNA levels between 0-2000 IU/mL (inactive carrier state) and willing to start and maintain antiviral treatment for at least the duration of the study.
✕. HBV DNA levels \> 2000 IU/mL but on prophylactic antiviral treatment for the past 3 months and will maintain the antiviral treatment during the study.
✕. Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction test result is negative for HCV RNA.
✕. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
✕. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior pneumonectomy (complete) or require supplemental oxygen (including intermittent or discretionary use).