Key eligibility: Adults (≥18) with advanced/metastatic HER2+ tumors (measurable per RECIST 1.1), ECOG 0-1, life expectancy ≥12 weeks. Major exclusions: active CNS metastases requiring steroids (>10mg prednisone), Grade ≥2 peripheral neuropathy, QTcF >450/470ms (M/F), active ILD/pneumonitis, HIV/HBV/HCV infections, or prior cumulative doxorubicin >360mg/m2. Fresh tumor tissue required for HER2 confirmation.

Key eligibility: Adults (≥18) with advanced/metastatic HER2+ tumors (measurable per RECIST 1.1), ECOG 0-1, life expectancy ≥12 weeks. Major exclusions: active CNS metastases requiring steroids (>10mg prednisone), Grade ≥2 peripheral neuropathy, QTcF >450/470ms (M/F), active ILD/pneumonitis, HIV/HBV/HCV infections, or prior cumulative doxorubicin >360mg/m2. Fresh tumor tissue required for HER2 confirmation.

Key eligibility: Adults (&ge;18) with HER2-positive/HER2-low metastatic BC (1-3 prior chemo regimens, T-DXd exposed), measurable disease (RECIST 1.1), ECOG 0-1. Major exclusions: active CNS metastases, prior eribulin, Grade &ge;2 peripheral neuropathy/ILD, QTcF >470ms, uncontrolled infections (HIV/HBV/HCV exceptions), or LVEF <50%. Tumor tissue must be available for central HER2 confirmation.

Eligible patients are adults (&ge;18 years) with histologically confirmed advanced/metastatic solid tumors (RECIST 1.1 measurable lesions), ECOG 0-1, and adequate organ function. Key exclusions include recent anticancer therapy, uncontrolled CNS metastases, &ge;Grade 2 peripheral neuropathy, active pneumonitis/ILD, or significant comorbidities (e.g., QTc prolongation). Contraception is required during treatment and for 6 months post-dose.

Eligibility requires histologically confirmed metastatic NSCLC adenocarcinoma (IASLC 8th ed.), measurable disease (RECIST 1.1), and ECOG PS 0-1. Exclusions include non-adenocarcinoma NSCLC histologies, uncontrolled third-space fluid accumulation, prior pneumonectomy (<12 months), recent chest radiotherapy (<6 months), and protocol-specified criteria affecting safety or study integrity.

Safety monitoring tracks adverse events (AEs), serious AEs (SAEs), treatment-related AEs/SAEs, AEs of special interest (AESIs), deaths, and lab abnormalities over 2 years. Key efficacy measures include progression-free survival (PFS), disease control rate (DCR), and duration of response (DoR), all assessed via RECIST 1.1 by investigators during the same 2-year period.

Eligible participants must have confirmed high-grade serous ovarian/peritoneal/fallopian tube cancer with platinum-resistant disease (1-3 prior lines) and measurable progression per RECIST v1.1. Key exclusions include non-HGS histologies, platinum-refractory status, significant pulmonary/ILD issues, uncontrolled effusions, hypersensitivity to study drugs, and protocol-specified lab/clinical abnormalities that may compromise safety or interpretation.

Secondary outcomes include comprehensive safety monitoring of adverse events (AEs), serious AEs (SAEs), AE-related discontinuations, and laboratory abnormalities, along with efficacy assessments of disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) by RECIST v1.1 - all tracked for 2 years to characterize the treatment's overall risk-benefit profile.

Eligible participants (&ge;20 years, ECOG 0-1) require FRA-positive solid tumors (Part 1) or specific ovarian/NSCLC histologies (Part 2) with adequate organ function. Key exclusions: uncontrolled cardiovascular disease, active infections, ILD, brain metastases, prior FRalpha/eribulin intolerance, or concurrent malignancies. Reproductive-age participants must use contraception, and prior anticancer therapies require appropriate washout periods (2-4 weeks depending on treatment type).

The study evaluates safety through dose-limiting toxicities (DLTs) in Cycle 1 (21 days), including severe hematologic events (grade 4 neutropenia/thrombocytopenia/anemia) and clinically significant grade 3-4 non-hematologic toxicities. Additional safety assessments over 50 months monitor AEs, SAEs, lab abnormalities, vital signs, ECOG PS changes, and immunogenicity via ADA titers to characterize the treatment's long-term safety profile.

Pharmacokinetics analysis measures maximum serum concentration (Cmax) of farletuzumab ecteribulin, total antibody, and free eribulin to establish the maximum tolerated dose (MTD) and recommended dose (RD) based on DLT rates (target 25%). Efficacy outcomes over 50 months include RECIST v1.1-based responses (ORR, DCR, CBR, BOR), with Part 2 specifically tracking survival metrics (PFS, OS) and duration of response (DOR) in defined cohorts.

Eligible participants (&ge;18 years, ECOG 0-1) include platinum-resistant ovarian, TNBC, NSCLC adenocarcinoma, or endometrial cancer patients with measurable disease and adequate organ function. Key exclusions: prior FRalpha/eribulin therapy, uncontrolled cardiovascular/autoimmune conditions, active infections (HIV/hepatitis), untreated brain metastases, pregnancy, or ILD risk factors (e.g., abnormal PFTs, chest radiotherapy <2 years). Contraception is mandated for reproductive-age participants, with washout periods (2-4 weeks) required for prior therapies.

The study assesses safety through dose-limiting toxicities (DLTs) in Cycle 1 (21 days), including severe hematologic and non-hematologic events (grade 3-4 per NCI CTCAE v5.0). Long-term safety (up to ~4 years 8 months) monitors SAEs, AEs leading to discontinuation, AEIs (e.g., ILD), lab/vital sign abnormalities, and immunogenicity via ADA titers. Efficacy endpoints include ORR (RECIST v1.1, up to ~24 weeks) and dose-finding for the RP2D.

Secondary outcomes evaluate pharmacokinetics (Cmax, AUC, t½) of farletuzumab ecteribulin and its components, alongside RECIST v1.1-based efficacy measures (DOR, DCR, CBR, PFS, OS) over ~4.8 years. Exploratory analyses correlate tumor FRA expression with clinical outcomes (ORR, PFS). Additional metrics include ECOG PS changes, SpO2 levels, and cardiac/laboratory parameters to comprehensively assess treatment impact.

Threefold serial dilutions of MORAb-202 (5.1x10¹² - 1.0x10⁷ mol/L) were added to the cell lines, and the cells were cultured for 5 days. Cells were stained with 0.2% crystal violet solution, a triarylmethane dye which accumulates in the nucleus of viable cells, washed with water, and solubilized with 1% sodium dodecyl sulfate. The viable cell number was determined by measuring the optical density (OD 570 nm) of the resulting lysate.

Threefold serial dilutions of MORAb-202 (5.1x10¹² - 1.0x10⁷ mol/L) were added to the cell lines, and the cells were cultured for 5 days. Cells were stained with 0.2% crystal violet solution, a triarylmethane dye which accumulates in the nucleus of viable cells, washed with water, and solubilized with 1% sodium dodecyl sulfate. The viable cell number was determined by measuring the optical density (OD 570 nm) of the resulting lysate.

Threefold serial dilutions of MORAb-202 (5.1x10¹² - 1.0x10⁷ mol/L) were added to the cell lines, and the cells were cultured for 5 days. Cells were stained with 0.2% crystal violet solution, a triarylmethane dye which accumulates in the nucleus of viable cells, washed with water, and solubilized with 1% sodium dodecyl sulfate. The viable cell number was determined by measuring the optical density (OD 570 nm) of the resulting lysate.

Threefold serial dilutions of MORAb-202 (5.1x10¹² - 1.0x10⁷ mol/L) were added to the cell lines, and the cells were cultured for 5 days. Cells were stained with 0.2% crystal violet solution, a triarylmethane dye which accumulates in the nucleus of viable cells, washed with water, and solubilized with 1% sodium dodecyl sulfate. The viable cell number was determined by measuring the optical density (OD 570 nm) of the resulting lysate.