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This is a phase 1, multicenter, open-label, first-in-human study of YL202 conducted in the United States and China.
The study will evaluate the safety and tolerability of YL202 in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC or hormone receptor (HR)-positive and HER2-negative BC, which have been heavily treated by standard treatment.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria
Patients must satisfy all of the following criteria to be included in the study:
Informed of the trial before the start of the trial and voluntarily sign their name and date on the informed consent form
Aged ≥18 years
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2
Adequate organ and bone marrow function, defined as follows:
Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug.
Life expectancy of ≥3 months
Able and willing to comply with protocol visits and procedures
For NSCLC patients:
Have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC not amenable to curative surgery or radiation
Have a documentation of an EGFR-activating mutation (exon 19 deletion or L858R) detected from tumor tissue at diagnosis or thereafter. Participants who have this EGFR mutation detected from blood sample may be eligible on a case-by-case basis after discussion with the sponsor.
Have documentation of disease progression on or after, or are intolerant to most recent treatment regimen for locally advanced or metastatic disease. Participants must have received all of the following:
For BC patients:
Note 1: Prior treatments with PI3K inhibitors, mTOR inhibitors, AKT inhibitors, and PARP inhibitors are allowed.
Note 2: If a patient develops disease relapse/progression during or within 6 months after the end of the (neo-)adjuvant therapy, or radical radiotherapy and chemotherapy, the treatment regimen will be counted as one line of treatment for locally advanced or metastatic disease, for the purpose of this inclusion criteria.
Have at least 1 measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Willing to provide archival or fresh tumor tissue samples for assessment of HER3 expression level. Patients who are not able to provide tumor samples or have inadequate samples may be eligible after discussion with the sponsor.
Exclusion Criteria
Patients who meet any of the following criteria will be disqualified from entering the study:
Prior treatment with an agent targeting HER3 (including antibody, ADC, chimeric antigen receptor T cell [CAR-T], and other drugs)
Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and DXd (e.g., severe diarrhea)
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
Inadequate washout period for prior anticancer treatment before the first dose of study drug, defined as follows:
Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study
Prior allogeneic bone marrow transplantation or solid-organ transplantation
Received systemic steroids (>20 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. The following are exceptions to this criterion:
Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study
A history of leptomeningeal carcinomatosis
Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 2 weeks before the first dose of study drug
Uncontrolled or clinically significant cardiovascular disease, including but not limited to:
A history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Clinically significant concomitant pulmonary disease, including but not limited to:
Patients with active or chronic corneal disorders, or patients with other active ocular conditions requiring ongoing therapy or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
Have a diagnosis of Gilbert's syndrome
Uncontrolled third-space fluid (e.g., pleural effusions, ascites, pericardial effusions) that requires repeated drainage
Active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal conditions that may cause bleeding or perforation by the investigator's discretion
Active infection that requires systemic therapy within 1 week before the first dose. Patients receiving prophylactic anti-infective therapy (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible after discussion with the sponsor.
Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with HIV, HBV, or HCV infection may be enrolled after evaluation of eligibility based on FDA's guideline Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections
Any other primary malignancy within 3 years before the first dose of study drug, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other curatively treated solid tumors
Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible after discussion with the sponsor.
A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies
Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 3 days before the first dose
Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.
Primary purpose
Allocation
Interventional model
Masking
80 participants in 1 patient group
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Central trial contact
Alan Xu, Ph.D.; Sasha Stann
Data sourced from clinicaltrials.gov
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