Actively Recruiting
Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
Led by Linnaeus Therapeutics, Inc. · Updated on 2025-12-18
200
Participants Needed
10
Research Sites
425 weeks
Total Duration
On this page
Sponsors
L
Linnaeus Therapeutics, Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This Phase 1/2, first-in-human, open-label, multicenter study follows a 3+3 ascending dose escalation design to determine the MTD/RP2D and to characterize the safety, tolerability, PK, and antitumor effects of LNS8801 alone and in combination with pembrolizumab. The study will include a dose escalation phase, a dose expansion phase, and phase 2A cohorts. Up to 200 patients will be accrued for this study. Up to 15 study sites in the United States will participate in the study.
CONDITIONS
Official Title
Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with histopathologically confirmed locally advanced or metastatic solid tumor cancer (or lymphoma in Phase 1).
- Ability to understand and voluntarily sign informed consent and comply with protocol.
- Measurable disease per RECIST v1.1 or RANO as assessed by investigator.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Estimated life expectancy greater than 3 months.
- Agreement to biopsies if lesions are surgically accessible.
- Ability to swallow capsules and tablets.
- Adequate organ and bone marrow function as defined by specific laboratory values.
- Female patients of childbearing potential must have negative pregnancy tests and use highly effective contraception.
- Male patients must be surgically sterile or use highly effective double-barrier contraception and agree not to donate sperm during the study.
- No remaining standard of care therapies or patient declines standard of care (with exceptions in some cohorts).
- Specific cancer types and prior treatments as defined per cohort.
You will not qualify if you...
- Thyroid or gall bladder cancer (excluded only in Phase 1 cohorts).
- Any estrogen receptor-positive cancer.
- Recent anticancer therapy within 4 weeks or 6 weeks for certain drugs.
- Unresolved toxicities from previous anticancer therapy above specified grade.
- Prior allogeneic hematopoietic stem cell transplantation within 5 years (for combination cohorts).
- Participation in another investigational study within 4 weeks before first dose.
- Symptomatic primary CNS tumors or untreated CNS metastases.
- Use of anti-TNF therapies recently.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- Immunodeficiency, immunosuppressive therapy, or systemic steroid use above specified doses.
- Recent major surgery or radiotherapy within specified time frames.
- Evidence or history of pneumonitis or interstitial lung disease.
- Active infections such as HIV, hepatitis B or C requiring systemic therapy.
- Active malabsorption syndrome or conditions affecting drug absorption.
- Recent live vaccine within 30 days.
- Prolonged QT interval or risk factors.
- Prior treatment with GPER agonists.
- Use of strong cytochrome P450 inhibitors or inducers.
- Need for proton pump inhibitors.
- Estrogen treatment or hormone replacement therapy since cancer diagnosis.
- Pregnancy, breastfeeding, or planning pregnancy within study period.
- Other active malignancies within 2 years except certain localized cancers.
- Uncontrolled intercurrent illnesses or psychiatric/substance abuse disorders.
- Prior lung radiation exceeding 30 Gy within 6 months for NSCLC patients.
- Prior therapy with immune checkpoint inhibitors leading to severe immune-related adverse events.
- History of allogenic tissue or solid organ transplant.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
5
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
8
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
The START Center for Cancer Care
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
T
Tina Garyantes, PhD
CONTACT
M
Mackenzie Tseng-Lee, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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