A Study to Investigate LYL797 in Adults With Solid Tumors

Lyell Immunopharma

Status and phase

Active, not recruiting

Phase 1

Conditions

Relapsed Cancer

NSCLC, Recurrent

NSCLC Stage IV

TNBC - Triple-Negative Breast Cancer

High Grade Serous Carcinoma

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Non Small Cell Lung Cancer

Ovarian Cancer

Non-Small Cell Carcinoma of Lung, TNM Stage 4

Platinum-resistant Ovarian Cancer

Endometrial Cancer

Recurrent NSCLC

Non Small Cell Lung Cancer Metastatic

Advanced Lung Carcinoma

Primary Peritoneal Carcinoma

Non-small Cell Lung Cancer

Endometrioid Tumor

Triple Negative Breast Cancer

Recurrent Breast Cancer

Relapse/Recurrence

NSCLC

Advanced Breast Cancer

Treatments

Biological: LYL797

Study type

Interventional

Funder types

Industry

Identifiers

NCT05274451

LYL797-101

Details and patient eligibility

About

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.

Full description

This Phase 1, single-arm, open-label, multi-center, dose-escalation and expansion study will evaluate the safety and tolerability of LYL797, ROR1- targeted CAR T cells, in adults with relapsed and/or refractory ROR1+ triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), Ovarian cancer, or endometrial cancer. The dose-escalation phase includes patients with TNBC, NSCLC, Ovarian, or Endometrial cancer, and will investigate multiple dose levels to identify the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll patients with TNBC, NSCLC, Ovarian, or Endometrial cancer at the RP2D.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 immunosuppressive medications within 14 days of leukapheresis
Pregnant or lactating/nursing women