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

Who is this study for? Adults with relapse or refractory B-cell lymphoma
What treatments are being studied? LP-168
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is an open-label, multi-center Phase 1/2 study of oral LP-168 in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Jun Zhu, MD, PhD
zj@bjcancer.org
+86-010-88196596
Backup
Yuqin Song, MD, PhD
Time Frame
Start Date: 2021-07-06
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 200
Treatments
Experimental: Phase I Dose Escalation
Dose Escalation and determination of MTD; multiple dose levels of LP-168 to be evaluated
Experimental: Phase I Dose Expansion A
CLL/SLL patients treated with prior regimens.
Experimental: Phase I Dose Expansion B
CLL/SLL patients with no prior therapy.
Experimental: Phase I Dose Expansion C
MCL patients treated with prior regimens.
Experimental: Phase I Dose Expansion D
WM patients treated with prior regimens.
Experimental: Phase I Dose Expansion E
MZL patients treated with prior regimens.
Related Therapeutic Areas
Sponsors
Leads: Guangzhou Lupeng Pharmaceutical Company LTD.

This content was sourced from clinicaltrials.gov

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