Trial Title:
Study of LP-184 in Patients With Advanced Solid Tumors
NCT ID:
NCT05933265
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
LP-184
Phase 1
Lantern Pharma
Cancer
DNA damage repair
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LP-184
Description:
LP-184 is a small molecule alkylating agent causing tumor cell death through DNA damage.
Arm group label:
Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-184
Summary:
The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D
of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory
to standard therapy or for whom no standard therapy is available. The secondary
objectives are to characterize the PK of LP-184 and its metabolites in plasma and assess
clinical activity of LP-184.
Detailed description:
Patients who meet all eligibility criteria will be enrolled to receive treatment with
LP-184 at a dose determined based on the available cohort at the time of each patient's
enrollment. Patients will receive LP-184 infusion during Day 1 and Day 8 of each 21-day
cycle, for a minimum of two cycles. Patients will be monitored for safety, PK, and
clinical activity. Dose escalation is planned with minimum of 3 patient cohorts (starting
at dose level 1). After selection of the maximum tolerated dose (MTD), additional
patients will be enrolled at two dose levels, including the MTD, as determined by the
Safety Review Committee, until at least 10 patients each are treated at each dose to
determine the recommended phase 2 dose.
Criteria for eligibility:
Criteria:
Patient Inclusion Criteria:
1. ≥18 years of age
2. Provided signed written ICF and voluntary consent prior to any mandatory
study-specific procedures, sampling, and analyses.
3. Resolved acute effects of any prior therapy to baseline severity or ≤Grade 1 NCI
CTCAE except for AEs not constituting a safety risk by investigator judgment.
4. Have a histologically or cytologically documented advanced solid tumor that has
relapsed from or is refractory to standard treatment, or for which no standard
treatment is available.
5. ECOG performance status 0-1 or Karnofsky performance scale >60 for GBM patients.
6. Patients must have measurable disease per RECIST 1.1 or RANO criteria as applicable.
7. Patients must have life expectancy >3 months.
8. Adequate Liver, renal, bone marrow, and coagulation function as determined at
screening.
9. For CNS disease considerations, based on screening contrast brain MRI, patients must
have 1 of the following:
- No evidence of brain metastases
- Untreated brain metastases not needing immediate local therapy. For patients
with untreated CNS lesions >2.0 cm on screening contrast brain MRI, discussion
with and approval from the medical monitor is required prior to enrollment.
- Previously treated brain metastases. Patients on a chronic stable dose of ≤2 mg
total daily of dexamethasone (or equivalent) are eligible with discussion and
approval by the medical monitor.
Patients treated with CNS local therapy for newly identified lesions found on contrast
brain MRI performed during study screening are eligible to enroll if all of the following
criteria are met:
- Time since whole brain radiation therapy was ≥21 days prior to first dose of LP-184,
- Time since stereotactic radiosurgery was ≥7 days prior to first dose of LP-184, or
- Time since surgical resection was ≥28 days.
- Other sites of disease assessable by RECIST v1.1 are present.
Patient Exclusion Criteria:
1. Exposure to anti-cancer therapy within 2 weeks or within at least 5 half-lives
whichever is shorter; or 4 weeks from any biologics/immunotherapies or any
investigational therapy prior to the first dose of LP-184.
2. History of retinopathy and/or macular degeneration.
3. Has received radiation within 4 weeks of Cycle 1 Day 1.
4. Have acute and severe bacterial, viral, or fungal infection.
5. Known or demonstrated viral infection as listed below:
1. Seropositivity for HIV (only if required by local regulations).
2. Hepatitis B and/or hepatitis C infection (as detected by positive testing for
hepatitis B surface antigen or antibody to hepatitis C virus with confirmatory
testing).
6. Are pregnant or breastfeeding.
7. Have clinically significant cardiac disease as determined at screening.
8. Have clinically significant AEs that have not returned to baseline or ≤Grade 1 based
on NCI-CTCAE unless approved by the sponsor. Patients with chronic Grade 2
toxicities may be eligible per the discretion of the investigator and sponsor (e.g.,
Grade 2 chemotherapy-induced neuropathy or hypothyroidism from prior immunotherapy
treatment).
9. Have had major surgery (requiring general anesthesia) within ≤4 weeks of first dose
of LP-184.
10. Have any other serious medical condition which, in the opinion of the investigator,
would preclude the patient from study participation.
11. Have clinically active brain metastases, defined as untreated and symptomatic, or
requiring therapy with steroids or anticonvulsants to control associated symptoms.
Patients with treated brain metastases that are no longer symptomatic and who
require no treatment with steroids may be included in the study if they have
recovered from the acute toxic effect of radiotherapy. A minimum of 3 weeks must
have elapsed between the end of whole brain radiotherapy and study enrollment (1
week for stereotactic radiotherapy).
12. For patients with CNS metastatic disease, based on screening brain MRI, patients
must not have:
- Any untreated brain lesions >2.0 cm in size, unless medical monitor approved
enrollment.
- Ongoing use of systemic corticosteroids for control of symptoms of brain
metastases at a total daily dose of >2 mg of dexamethasone (or equivalent).
- Patients on a chronic stable dose of ≤2 mg total daily of dexamethasone (or
equivalent) are eligible with discussion and approval by the medical monitor.
- Any brain lesion thought to require immediate local therapy, including (but not
limited to) a lesion in an anatomic site where an increase in size or possible
treatment-related edema may pose a risk to the patient (e.g., brain stem
lesions). Patients who underwent local treatment for such lesions identified by
screening contrast brain MRI may still be eligible based on criteria described
under CNS inclusion criteria described above.
- Known or suspected leptomeningeal disease as documented by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Highlands Oncology Group
Address:
City:
Springdale
Zip:
72758
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amie Winn
Phone:
479-502-9289
Email:
Awinn@hogonc.com
Investigator:
Last name:
Joseph T Beck
Email:
Principal Investigator
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Contact:
Last name:
Trong Nguyen
Phone:
562-735-0602
Email:
tnguyen@cbsclinic.com
Contact backup:
Last name:
Stefi Guillen
Email:
sguillen@cbs.com
Investigator:
Last name:
Vu Phan, MD
Email:
Principal Investigator
Investigator:
Last name:
Nihal Abdulla, MD
Email:
Sub-Investigator
Facility:
Name:
Northwest Oncology & Hematology
Address:
City:
Rolling Meadows
Zip:
60008
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nowsheen Azeemuddin
Phone:
847-577-0620
Email:
nowsheena@northwestoncology.com
Investigator:
Last name:
Bruce Bank, MD
Email:
Principal Investigator
Investigator:
Last name:
Marina Messinger, MD
Email:
Sub-Investigator
Investigator:
Last name:
Gary E Kay, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ronald J Shade, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tonia Cabai, NP-C
Email:
Sub-Investigator
Investigator:
Last name:
Cristyn Savoia, APN
Email:
Sub-Investigator
Facility:
Name:
John Hopkins - The Sidney Kimmel Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina Raynor
Email:
craynor1@jhmi.edu
Facility:
Name:
Indiana University Melvin and Bren Simon Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cassandra Brass
Email:
cassbass@iu.edu
Investigator:
Last name:
Misty Shields
Email:
Principal Investigator
Facility:
Name:
Norton Healthcare, Inc.
Address:
City:
Louisville
Zip:
40205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Buchanan
Phone:
502-629-2500
Phone ext:
19472
Email:
Michael.Buchanan@nortonhealthcare.org
Investigator:
Last name:
John Hamm
Email:
Principal Investigator
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ikenna Opurum
Phone:
267-418-6160
Email:
ikenna.opurum@fccc.edu
Investigator:
Last name:
Anthony Olszanski, MD
Email:
Principal Investigator
Facility:
Name:
UT Health Science Center San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jasmine Deblanc
Email:
deblanc@uthscsa.edu
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Contact:
Last name:
Casey Larsen
Phone:
801-907-4752
Email:
casey.larsen@startthecure.com
Investigator:
Last name:
William McKean, MD
Email:
Principal Investigator
Start date:
June 9, 2023
Completion date:
June 9, 2025
Lead sponsor:
Agency:
Lantern Pharma Inc.
Agency class:
Industry
Source:
Lantern Pharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05933265
