A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors

Atridia

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: SHR-1921

Study type: Interventional

Funder types: Industry

Identifiers

NCT05594875

SHR-A1921-I-102-AUS

Details and patient eligibility

About

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able and willing to provide a written informed consent
2. Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content
3. Male or female
4. Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy
5. ECOG performance status of 0-1

Exclusion criteria

1. Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites
2. Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression
3. Has known history of other documented malignancy
4. Has known history of acquired immunodeficiency syndrome (AIDS)
5. Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure
6. Has active or prior documented interstitial pneumonia/interstitial lung disease
7. Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose
8. Has known active hepatitis B
9. Has known allergies to SHR-1921 component
10. Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

SHR-1921

Experimental group

Treatment:

Drug: SHR-1921