NCT05341557 A Phase 1 Study of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed/Refractory Lymphoma
| NCT ID | NCT05341557 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Betta Pharmaceuticals Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2022-08-29 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 110 participants in total. It began in 2022-08-29 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-371153, a PD-L1 Inhibitor, in patients with advanced solid tumors or relapsed/refractory lymphoma.
Eligibility Criteria
Inclusion Criteria: * Dose escalation phase: Age ≥18 and ≤65 years, male and female patients; Dose expansion phase: Age ≥18, male and female patients; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; * Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients) or relapsed/refractory lymphoma, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists; * Dose expansion phase: histologically or cytologically confirmed locally advanced or relapsed/metastatic Non-Driver Mutation NSCLC, relapsed/refractory lymphoma, HCC with Child-Pugh A or B(≤ 7 points), or other diagnosed solid tumor patients who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists; * Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1( for other diagnosed solid tumos excluding HCC), mRECIST(for HCC) or Lugano 2014(for lymphoma); * Adequate organ function; Exclusion Criteria: * Dose escalation phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy; * Dose expansion phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy within 28 days prior to treatment. Subjects with a history of a Grade 3 or higher immune-related AE from prior immunotherapies; * Prior other specific T cell targeting agents; * Use of systemic or absorbable topical corticosteroids therapy(≥ 10 mg/day prednisone or equivalent) two weeks prior to start of treatment. * Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, and vaccine; * Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc; * Pregnancy or lactation; * Other conditions considered not appropriate to participate in this trial by the investigators.
Contact & Investigator
Yuankai Shi, Ph.D
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT05341557 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05341557 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05341557 currently recruiting?
Yes, NCT05341557 is actively recruiting participants. Contact the research team at syuankaipumc@126.com for enrollment information.
Where is the NCT05341557 trial being conducted?
This trial is being conducted at Chaoyang, China, Cangzhou, China, Tianjin, China, Tianjin, China.
Who is sponsoring the NCT05341557 clinical trial?
NCT05341557 is sponsored by Betta Pharmaceuticals Co., Ltd.. The principal investigator is Yuankai Shi, Ph.D at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 110 participants.