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New treatment option for Adenoid Cystic Carcinoma
Official title Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)
ClinicalTrials.gov ID: NCT07162480
What this study is testing
What is P-Sam?
P-Sam is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adenoid cystic carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- (exclusion criteria #18). Exclusion Criteria:
- Treatment with any of the following as detailed below in Table 2: Table 2 . Washout period from prior therapies Treatment Washout period Nitrosourea...
- Unresolved toxicities of Grade ≥ 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE version 5.0) from prior...
- Active infection, including tuberculosis, SARS-CoV-2, and known infections with hepatitis B virus (HBV), hepatitis C virus (HCV) or human...
- Negative for HBsAg and positive for total hepatitis B core antibody (anti-HBc) or Positive for HBsAg, but for \> 6 months have had normal...
- 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.
See the full eligibility criteria
Who can join
- 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
- Patient has provided informed consent.
- Adequate bone marrow, hepatic, and renal function with the most recent laboratory assessments 8. Contraceptive use by the participant or the participant's partner should be consistent with local regulations regarding...
What rules you out
- (exclusion criteria #18). Exclusion Criteria:
- Treatment with any of the following as detailed below in Table 2: Table 2 . Washout period from prior therapies Treatment Washout period Nitrosourea or mitomycin C Within 6 weeks prior to the first dose of study...
- 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...
- 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...
- 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)...
- 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...
- Patients with history of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). Specific screening for MDS/AML is not...
- Participants with any of the following cardiac criteria:
- History of clinically significant arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (NCI CTCAE version 5.0 Grade...
- Uncontrolled hypertension.
- Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months of the start of...
- History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.
- Symptomatic heart failure (as defined by New York Heart Association class ≥ 2).
- Prior or current cardiomyopathy.
- Severe valvular heart disease.
- Resting corrected QT interval using Fridericia's formula (QTcF) \> 470 msec
- Any factors that increase the risk of corrected QT (interval) (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden...
- Concomitant medications known to prolong QTc should be used with caution and cannot be used starting with the first dose of study intervention or during the scheduled ECG assessments (see \ \>).
- Active CNS disease (patients with asymptomatic or treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks prior to start of study treatment are not considered...
- Uncontrolled intercurrent illness within the last 12 months of start of study treatment, including but not limited to serious chronic GI conditions associated with diarrhea, or psychiatric illness/social situations that...
- Has substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the...
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants, if enrolled, should not receive live attenuated vaccine whilst receiving study intervention and up to...
- For women only - currently pregnant (confirmed with positive pregnancy test), lactating, breastfeeding, or intend to become pregnant during the study.
- Red blood cell transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening.
- Current participation in another treatment clinical study
- History of previous malignancy other than malignancy treated with curative intent and low risk of recurrence. Patients with the following diagnoses represents an exception and may enroll if ≥ 2 years with no evidence of...
- Non-melanoma skin cancers with no current evidence of disease
- Melanoma in situ with no current evidence of disease
- Treated or localized, low-risk, cancer of the prostate with prostate-specific antigen of \<1 ng/mL
- Treated or localized well-differentiated thyroid cancer (stage I)
- Cervical carcinoma in situ
- Treated ductal/lobular carcinoma in situ of the breast
- Treated or localized, low grade, renal cell carcinoma (stage I)
- Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient
- Cognitively impaired patients who are incompetent to consent.
- Prior exposure to a B7-H4 targeting ADC, or any prior agent with a topoisomerase inhibitor 1 mode of action.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.