A Study to Investigate LYL797 in Adults With Solid Tumors (NCT05274451) | Clinical Trial Compass
TerminatedPhase 1
A Study to Investigate LYL797 in Adults With Solid Tumors
Stopped: Pipeline Reprioritization
United States57 participantsStarted 2022-03-29
Plain-language summary
This study will evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer (Ovarian cancer), or Endometrial cancer. The first part of the study will determine the safe dose for the next part of the study, and will enroll patients with TNBC, NSCLC, Ovarian or Endometrial cancer. The second part of the study will test that dose in additional patients with TNBC, NSCLC, Ovarian or Endometrial cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
IInclusion Criteria:
* ≥ 18 years of age at time of informed consent
* Confirmation of ROR1 expression from a pretreatment tumor sample
* Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or locally advanced and unresectable
* Platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer.
* Endometrial cancer.
* Measurable disease including a target lesion and an additional lesion for biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate organ and marrow function
* Women of childbearing potential must have a negative pregnancy test at screening
* All participants must agree to practice highly effective methods of contraception
Exclusion Criteria:
* Prior treatment with any adoptive T-cell therapy or other anti-ROR1 therapy
* Prior solid organ transplantation
* Active, untreated brain metastasis or leptomeningeal disease; however, stable, treated brain metastases are allowed
* Untreated or active infection at the time of screening or leukapheresis
* HIV-positive, HTLV-1-positive, active acute HAV, acute or chronic HBV or HCV, or active tuberculosis
* Impaired cardiac function or clinically significant cardiac disease
* Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent drainage procedures (once monthly or more frequent), or lymphangitis carcinomatosis
* History of interstitial pneumonitis or pulmonary fibrosis.
* Systemic corticosteroids or other …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate incidence of dose-limiting toxicities (DLTs)
Timeframe: Up to 28 days
2
Evaluate incidence of treatment-emergent adverse events (TEAEs)
Timeframe: Up to 2 years
3
Evaluate severity of treatment-emergent adverse events (TEAEs)