Actively Recruiting
A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-12-31
80
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with or without Antitumor Therapy in Advanced Solid Tumors. To explore the reasonable dosage of SHR-A2102 for Advanced Solid Tumors.
CONDITIONS
Official Title
A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent and follow the treatment and visit plans
- Age 18 years or older
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Diagnosed with locally advanced unresectable or metastatic solid tumors; stage Ib patients have failed standard treatment; stage II patients have not had systemic antitumor therapy
- Can provide archived or fresh tumor tissue
- At least one measurable tumor lesion by RECIST v1.1 criteria
- Good organ function
- Use of effective contraception for men with partners of childbearing age and for fertile women
You will not qualify if you...
- Untreated or uncontrolled active central nervous system metastases
- Previous treatment with antibody-drug conjugates containing topoisomerase I inhibitors; stage II patients previously treated with PD-1/PD-L1 inhibitors
- Systemic antitumor therapy within 4 weeks before starting the study
- Palliative radiotherapy within 14 days before first dose; chest radiotherapy over 30 Gy within 6 months before starting
- Toxicities from prior antitumor therapy not resolved to mild levels (NCI-CTCAE 41)
- Systemic immunosuppressive therapy within 14 days before first dose
- Known or suspected interstitial pneumonia
- Grade 3 or higher immune-related adverse events from previous immune checkpoint inhibitors
- Any active, known, or suspected autoimmune disease
- Moderate or severe ascites with symptoms, uncontrolled moderate or higher pleural or pericardial effusion
- Uncontrolled cardiac symptoms or diseases
- Any other cancer diagnosed within the past 5 years
- Severe infection within 28 days before first dose
- Active hepatitis B or C
- Active tuberculosis within 1 year or untreated past active tuberculosis
- Immune deficiency history
- Live attenuated vaccines within 28 days before or during study
- Participation in another clinical study within 4 weeks or five half-lives of prior investigational drug
- Major surgery within 28 days or minor traumatic surgery within 7 days before first dose; non-healing wounds or untreated fractures
- Known severe allergic reactions to SHR-A2102 or related drugs
- Pregnant or planning pregnancy during the study
- Uncontrolled mental illness, substance abuse, or conditions interfering with study completion
- Other circumstances judged by investigators to increase risk or interfere with study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
C
Chi Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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