Actively Recruiting
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
48
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone.
CONDITIONS
Official Title
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed locally advanced, unresectable, or metastatic solid tumors with HER2 expression or amplification
- No prior treatment with trastuzumab deruxtecan (DS-8201a)
- For dose expansion, must have gastric or gastroesophageal junction cancer that progressed after prior treatment
- Received prior trastuzumab-based treatment if eligible
- Evaluable or measurable disease
- Recovered from adverse events of previous therapies
- ECOG performance status of 0 or 1 (Karnofsky 70%)
- Adequate blood counts and organ function within 7 days before treatment
- Left ventricular ejection fraction 50% by ECHO or MUGA within 28 days before enrollment
- Patients with controlled HIV, hepatitis B, or cured hepatitis C may participate
- Patients with treated brain metastases or stable brain metastases not requiring immediate treatment
- Life expectancy 3 months
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception
- Male patients must agree to use contraception and not donate sperm during and after study
- Ability and willingness to provide informed consent
- Willingness to undergo biopsy if required
- Adequate washout period from prior therapies before starting study treatment
You will not qualify if you...
- Use of moderate or strong CYP3A4 inhibitors or inducers (except for specified antiemetics)
- Participation in other investigational drug studies
- History of allergic reactions to similar drugs or severe hypersensitivity to monoclonal antibodies
- Severe lung diseases, autoimmune or inflammatory disorders involving lungs, or prior lung surgery
- Need for supplemental oxygen for daily activities
- Pregnancy or breastfeeding
- History or current interstitial lung disease or pneumonitis
- Active infections requiring treatment at study start
- Conditions impairing pill swallowing or absorption
- Signs of bowel obstruction
- Recent myocardial infarction, symptomatic heart failure, or abnormal troponin levels
- Significant corneal disease
- Pleural, pericardial, or ascitic effusions requiring drainage within 2 weeks before screening
- History of specific heart rhythm disorders
- Prolonged QT interval or congenital long QT syndrome
- Prior treatment with WEE1 inhibitors or trastuzumab deruxtecan or other topoisomerase inhibitors
- Uncontrolled illnesses
- Prior allogeneic organ or stem cell transplant
- Significant gastrointestinal disorders with frequent diarrhea
- Spinal cord compression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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