Testing LP-168 for patients with B-cell lymphoma that hasn't responded to previous treatments
A Phase 1 Open-Label Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of LP-168 in Adult Patients With Relapse or Refractory B-Cell Lymphoma
This study is testing a new oral medication called LP-168 to see if it can help patients with B-cell lymphoma who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Guangzhou Lupeng Pharmaceutical Company LTD. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT04993690 on ClinicalTrials.gov |
What this trial studies
This open-label, multi-center Phase 1 study evaluates the safety and efficacy of oral LP-168 in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and non-Hodgkin's lymphoma (NHL) who have not responded to or are intolerant of standard treatments. The study consists of two parts: a dose escalation phase (1a) to determine the maximum tolerated dose (MTD) and a dose expansion phase (1b) to further assess the drug's effectiveness. Participants will receive LP-168 in tablet form, starting at a dose of 100 mg per day, with treatment cycles lasting 28 days.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with relapsed or refractory B-cell lymphomas who have received at least one line of standard care treatment.
Not a fit: Patients with B-cell lymphomas that have not been classified as relapsed or refractory, or those who have not received prior treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with difficult-to-treat B-cell lymphomas.
How similar studies have performed: Other studies have shown promise with similar investigational therapies for B-cell lymphomas, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Per 2017 revised WHO lymphoma classification criteria, subject must have either: Diagnosed with relapsed or refractory DLBCL or FL and require treatment in the opinion of the Investigator and have received 2 lines SOC. Diagnosed with relapsed or refractory non-Hodgkin's lymphoma associated with B-cell proliferation (such as CLL\\ SLL \\ MCL \\ MZL \\ WM, etc.) in need of treatment in the opinion of the Investigator and have received 1 line SOC. * Adequate hematologic function. * Adequate hepatic and renal function. * Ability to receive study drug therapy orally and willing to receive examinations. * Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control. Key Exclusion Criteria: * According to the 2017 revised WHO Lymphoma Classification Criteria, patients diagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, and post-transplant lymphoproliferative disease(PTLD). * Prior malignancy (other than the disease under study) within the past 3 years, except for curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix or breast cancer. * Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of LP-168: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy. * Subjects who have received the following treatments within 2 weeks before the first dose of LP-168: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia. * Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections; Disease affects the central nervous system with obvious symptoms; Autoimmune hemolytic anemia or Idiopathic thrombocytopenic purpura. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters. * Subjects who cannot tolerate urine collection, venipuncture, lymph node biopsy, and bone marrow aspiration.
Where this trial is running
Beijing, Beijing Municipality and 2 other locations
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jun Zhu, MD, PhD
- Email: zj@bjcancer.org
- Phone: +86-010-88196596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.