New immune drug takes on Hard-to-Treat cancers
NCT ID NCT07583316
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new drug called CRPA1A2, which helps the body's immune cells attack cancer cells. It is for people with certain advanced solid tumors (like lung, esophagus, head and neck, or liver cancer) that have not responded to other treatments. The study will first find a safe dose, then test that dose in more patients to see if it shrinks tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CRPA1A2 (a bispecific T cell engager)
- What this could lead to
- If successful, this could point toward a new treatment option for certain advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early Phase 1 trial, so the main goal is safety, not effectiveness. It is very small and may not work in larger groups. Side effects from T cell engagers can be severe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with a histological and/or cytological confirmed locally advanced or metastatic unresectable solid tumor (including but not limited to esophageal squamous cell carcinoma, hepatocellular carcinoma, head and neck squamous cell carcinoma and lung squamous cell carcinoma) who have experienced disease progression following available standard therapy and for whom no further standard treatment options are available. 2. Patients with confirmed positive expression of MAGE-A1 (H-score ≥1, testing by IHC for FFPE) by central lab. 3. Patients with positive HLA-A\*02:01 (confirmed by the central lab). 4. There must be at least one measurable lesion per RECIST v1.1 criteria. (Lesions that have received radiotherapy previously cannot be considered target lesions unless there is evident progression after radiotherapy). 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1. 6. Life expectancy ≥ 3 months, in the opinion of the investigator. 7. Has adequate organ function, as demonstrated by laboratory values obtained during the screening period. 8. Participants (both males and females) of childbearing potential must agree to use highly efficient contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Exclusion Criteria: 1. Patients with history of other malignancies (within 2 years prior to signing the ICF) are excluded, except for those with cured stage IB or earlier stage cervical cancer, non-invasive basal cell or squamous cell skin cancer, malignant melanoma in complete remission (CR) for over 10 years, or other malignancies in complete remission (CR) for over 5 years. 2. Patients with positive HLA-A\*02:05 (confirmed by the central lab). 3. Patients with known sensitivity or immediate hypersensitivity to any components of CRPA1A2 or ingredients of CRPA1A2 injection. 4. Patients who have been exposed to other MAGE-A1 targeted therapy. 5. With clinically significant cardiovascular diseases, including but not limited to: 1. History of heart failure, myocardial ischemia or infarction, unstable angina, arrhythmias, or New York Heart Association (NYHA) Class III-IV within the past 6 months or currently. 2. With prolonged QT/QTc intervals on the electrocardiogram during the screening period (QTcF: \> 480 ms). 3. Echocardiogram (ECHO) indicates a left ventricular ejection fraction (LVEF) of ≤50% at screening. 4. Poorly controlled hypertension at screening (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg) despite pharmacological treatment. 5. History of vascular angioplasty, coronary artery bypass grafting, or other cardiac surgical procedures. 6. With clinically significant active hepatitis B, HBsAg or HBcAb positive and have an HBV-DNA level above the detection limit at screening (i.e., the upper limit of normal values at each research center's laboratory). With the exception for those that have achieved HBV-DNA negativity after antiviral treatment and have received at least 2 weeks of antiviral therapy before the initial dosing. Additionally, they must be willing to continue antiviral therapy for hepatitis B throughout the study period. For patients with hepatocellular carcinoma, HBV DNA must be \<1000 IU/mL for study eligibility. 7. Clinically significant active hepatitis C, indicated by positive HCV antibodies and HCV-RNA levels higher than the detection limit at screening (upper limit of normal values). 8. Positive Treponema pallidum antibodies (TP-Ab) and positive result for nonspecific syphilis antibodies titer (RPR) at screening. 9. Prior or concurrent therapies/procedures that may confound study evaluation or increase risk, including recent participation in another clinical study; recent anticancer therapy, investigational treatment, or invasive investigational medical device use; major surgery without full recovery; prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation; recent autologous hematopoietic stem cell transplantation; or planned transplantation during the study period. 10. Active, uncontrolled, or clinically significant medical conditions that may increase the risk of study participation or interfere with study assessments, including severe infection; symptomatic or uncontrolled central nervous system or leptomeningeal metastases; clinically significant pulmonary disease (e.g., interstitial lung disease/pneumonitis); coagulation or bleeding disorders; autoimmune disease or immunodeficiency (including HIV infection); or significant neurologic or psychiatric disorders. 11. Unresolved toxicities or other conditions considered by the investigator to make the participant unsuitable for the study, including failure to recover adequately from prior anticancer treatment-related toxicities, prior Grade ≥2 ICANS after T-cell engager or CAR-T therapy, clinically significant abnormal laboratory findings, or other severe/uncontrolled acute or chronic diseases, alcohol abuse, or substance misuse.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
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Other studies related to the condition(s) this trial covers.
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