Phase I SHR-A2102 for advanced solid tumors

An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of SHR-A2102 in Patients With Advanced Solid Tumors

This Phase I test gives SHR-A2102 to adults with advanced solid tumors to find a safe dose and see how safe it is and how the body processes the drug.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 395 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05701709 on ClinicalTrials.gov

What this trial studies

This is a Phase I, open-label, dose-escalation study of SHR-A2102 in adults with advanced or metastatic solid tumors who have failed or are intolerant to standard therapies. The trial will enroll patients with measurable disease and good performance status (ECOG 0–1) to identify dose-limiting toxicities, the maximum tolerated dose, and a recommended Phase II dose. Safety, tolerability, and pharmacokinetics will be closely monitored during and after dosing. The sponsor is Shanghai Hengrui Pharmaceutical and the study is conducted at Shanghai Chest Hospital in Shanghai, China.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed advanced or metastatic solid tumors, ECOG 0–1, measurable disease per RECIST 1.1, and who have failed or are intolerant of standard treatments are the intended candidates.

Not a fit: Patients with effective standard treatment options available, those who received anticancer therapy within 4 weeks, or those with poor performance status (ECOG ≥2) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify a safe dose of SHR-A2102 and potentially provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: Other early-phase oncology trials of novel agents have occasionally shown promising activity, but SHR-A2102's safety and efficacy have not been established in published reports and remain unproven.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. Age ≥18 years old, gender unlimited;
3. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \~ 1;
4. Life expectancy Predicted survival ≥3 months;
5. Histologically or cytologically confirmed advanced or metastatic malignant tumor; Patients with advanced solid tumors confirmed by pathology who have failed or been intolerant to standard treatment, have no standard treatment or refuse standard treatment;
6. There is at least one measurable lesion that meets the RECIST 1.1 criteria.

Exclusion Criteria:

1. Plan to receive any other antitumor therapy during this trial;
2. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study drug;
3. Received antitumor therapy such as chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to first administration of the study drug (nitrosourea or mitomycin C within 6 weeks prior to first administration; Oral fluorouracil within 2 weeks prior to initial first administration); Palliative radiotherapy or local therapy within 2 weeks before first administration use of the study drug;
4. Had major surgery other than diagnosis or biopsy within 4 weeks prior to the study's initial dosing;
5. Treatment with CYP3A4, CYP2D6, P-gp or BCRP booster or inducer is less than 5 drug half-life from the date of first administration;
6. According to NCI-CTCAE v5.0, adverse events caused by previous antitumor therapy did not recover to ≤ grade 1 (except hair loss; In the judgment of the investigator, after consultation with the sponsor, some tolerable chronic grade 2 toxicity may be excluded);
7. Inadequately treated central nervous system (CNS) metastases, or the presence of uncontrolled or symptomatic active CNS metastases, may be characterized by the presence of clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia meningeal disease, and/or rapid progression. Patients with CNS metastases that have been adequately treated and whose neurological symptoms return to baseline at least 4 weeks prior to randomization (except for residual signs or symptoms associated with CNS treatment) may be enrolled. In addition, subjects must either stop corticosteroids or receive prednisone (or an equivalent dose of another corticosteroid) at least 4 weeks prior to randomization;
8. Any other malignancies, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix, etc. within 5 years prior to initial administration;
9. A history of clinically significant lung disease (such as interstitial pneumonia, radiation pneumonia, pulmonary fibrosis) or chest imaging during screening suggests any such disease;
10. Severe infections that require intravenous antibiotic, antiviral or antifungal control;
11. Active HBV or HCV infection (HBsAg positive and viral copy number ≥2000 IU/mL, HCV antibody positive and HCV RNA higher than the lower limit of detection method);
12. History of immunodeficiency (including HIV positive, other acquired or congenital immunodeficiency diseases) or organ transplantation;
13. Concomitant diseases (such as severe diabetes, thyroid disease, and psychosis) or any other conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's ability to complete the study.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Fei Luo

Conditions Advanced Solid Tumors