Eligible patients include adults (≥18 years) with HER2-positive/low-expression solid tumors failing standard therapy, measurable lesions (RECIST v1.1), ECOG 0-1, and adequate organ function. Exclusions: recent antitumor therapy (4 weeks/5 half-lives), severe cardiovascular disease, uncontrolled hypertension, active infections, CNS metastasis symptoms, or prior organ transplantation.

This study included subjects with locally advanced or metastatic HER2 expressing (positive/low) breast cancer (BC) and other solid tumors. BL-M07D1 would be administered at doses of 1.0mg/kg Day 1 & Day 8 every 3 weeks (D1D8 Q3W) or 2.6, 3.2, 3.8, 4.4, 5.0, 5.6, 6.2, 6.8 and 7.4 mg/kg Day 1 every 3 weeks (D1Q3W) during dose escalation (D-ESC). A subset of patients (pts) will be enrolled in the dose-expansion phase (D-EXP) at D1 Q3W regimens.

Eligible patients include adults (≥18 years) with HER2-positive/low-expression solid tumors failing standard therapy, measurable lesions (RECIST v1.1), ECOG 0-1, and adequate organ function. Exclusions: recent antitumor therapy (4 weeks/5 half-lives), severe cardiovascular disease, uncontrolled hypertension, active infections, CNS metastasis symptoms, or prior organ transplantation.

This study included subjects with locally advanced or metastatic HER2 expressing (positive/low) breast cancer (BC) and other solid tumors. BL-M07D1 would be administered at doses of 1.0mg/kg Day 1 & Day 8 every 3 weeks (D1D8 Q3W) or 2.6, 3.2, 3.8, 4.4, 5.0, 5.6, 6.2, 6.8 and 7.4 mg/kg Day 1 every 3 weeks (D1Q3W) during dose escalation (D-ESC). A subset of patients (pts) will be enrolled in the dose-expansion phase (D-EXP) at D1 Q3W regimens.

Enrollment requires HER2+ breast cancer patients (18-75 years) with measurable disease (RECIST 1.1), ECOG 0-1, LVEF &ge;50%, and adequate organ function (INR &le;1.5, urine protein <1000mg/24h). Key exclusions: prior HER2-ADC/camptothecin-ADC treatment, active CNS metastases, cardiovascular risks (QTc prolongation, uncontrolled HTN), ILD history, recent anticancer therapy (varies by modality), infections (HIV/HBV/HCV), anthracycline exposure >360mg/m2, or effusions requiring frequent drainage. Reproductive-age patients must use contraception.

The primary efficacy endpoint is progression-free survival (PFS), evaluated by blinded independent central review (BICR) over 24 months, measuring time from randomization to disease progression or death. Key secondary efficacy measures include overall survival (OS) and objective response rate (ORR) - calculated as complete (CR) and partial responses (PR) proportion in FAS population. Disease control incorporates stable disease (SD) with CR/PR for DCR assessment.

Safety evaluations focus on treatment-emergent adverse events (TEAEs) for 24 months, documenting any clinically significant changes during BL-M07D1 treatment. Immunogenicity is assessed through anti-drug antibody (ADA) frequency. Duration of response (DOR) tracks the period from initial tumor response to progression/death. All efficacy assessments follow RECIST 1.1 criteria, with tumor measurements performed using standardized imaging evaluations.

Eligible HER2+ breast cancer patients (18-75 years, ECOG 0-1) must have measurable lesions (RECIST 1.1) and adequate organ function (LVEF &ge;50%, INR &le;1.5). Key exclusions involve prior camptothecin-ADC treatment, uncontrolled comorbidities (HTN, QT prolongation), active CNS metastases, recent anticancer therapy (varies by modality), ILD history, anthracycline overdose (>360mg/m2), active infections (HIV/HBV/HCV), or effusions requiring intervention. Reproductive precautions are mandated throughout treatment and for 7 months post-therapy.

The study evaluates efficacy through ORR (confirmed CR/PR per RECIST 1.1) and establishes RP2D for BL-M07D1 by integrating safety, tolerability, and pharmacokinetic/pharmacodynamic data from dose escalation. Primary endpoints include tumor response assessment with CR defined as target lesion disappearance and PR as ≥30% reduction in lesion diameter sum.

Eligible participants are women (18-75 years) with AJCC 8th edition stage T1-4/N0-3 M0 (excluding T1N0) HER2+ invasive breast cancer who completed neoadjuvant therapy and mastectomy, showing residual disease. Exclusions include metastatic disease, prior HER2-ADC therapy, anthracycline overdose (>240mg/m2 doxorubicin equivalent), uncontrolled comorbidities (cardiac/pulmonary disorders, HTN), active infections (HIV/HBV/HCV), or immunosuppressive therapy use. Strict reproductive safeguards are enforced throughout the study period.

Secondary endpoints evaluate disease-free survival (DFS), distant recurrence-free interval (DRFI), and overall survival (OS). Treatment-emergent adverse events (TEAEs) are rigorously monitored per NCI-CTCAE v5.0 criteria, documenting any clinically significant changes during BL-M07D1 administration to assess safety profile over the 77-month follow-up.

Eligibility requires adults (&ge;18 years) with HER2-expressing (IHC 1+/3+ or gene-amplified) advanced/metastatic solid tumors (e.g., endometrial, breast, gastric cancers) refractory to &ge;2 prior therapies, measurable lesions (RECIST v1.1), ECOG 0-1, and adequate organ function (LVEF &ge;50%, INR/APTT &le;1.5&times;ULN). Exclusions cover recent antitumor therapies (chemotherapy/surgery within 2-6 weeks), uncontrolled comorbidities (QTc >470ms, hypertension, Grade 3 lung disease), active infections (HIV/HBV/HCV), prior anthracyclines (>360mg/m2), CNS metastases unless stable &ge;4 weeks, and allergies to BL-M07D1 components. Reproductive safeguards are mandated.

The study assesses safety parameters including dose-limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent AEs (TEAEs), physical exams, vital signs, lab results, ECG, and echocardiograms over 24 months. Key dose objectives include identifying the maximum tolerated dose (MTD) or maximum administered dose (MAD) and at least two recommended expansion doses (RDEs) of BL-M07D1 based on DLT evaluation within 21 days.

Eligible patients (18-75 years) have HER2-positive/IHC2+/ISH+ or low-expressing (IHC1+/2+ISH-) advanced solid tumors refractory to standard therapy, measurable lesions (RECIST v1.1), ECOG 0-1, and adequate organ function (LVEF&ge;50%, ANC&ge;1.5&times;10⁹/L). Exclusions cover recent antitumor therapies (4 weeks/5 half-lives), cardiovascular risks (QTc>450/470ms, NYHA&ge;2), active infections (HIV/HBV/HCV), prior topoisomerase I inhibitor ADCs (Phase Ib), uncontrolled effusions, or CNS metastases unless stable >4 weeks post-treatment. Reproductive safeguards are mandatory.

Key outcomes include Treatment-Emergent Adverse Events (TEAEs, 24-month monitoring) and pharmacokinetic metrics (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough within 21 days). Immunogenicity (anti-drug antibody frequency/titer) and efficacy endpoints (ORR, DCR, DOR, PFS, OS per RECIST 1.1) are tracked over 24 months to assess BL-M07D1's therapeutic profile.

Eligible participants (&ge;18 years) have HER2-positive (IHC3+/IHC2+FISH+) or low-expressing (IHC1+/IHC2+FISH-) advanced solid tumors refractory to standard therapy, measurable lesions (RECIST v1.1), ECOG 0-1, and adequate organ function (LVEF&ge;50%; ANC&ge;1.5&times;10⁹/L). Exclusions include recent antitumor therapies (4 weeks/5 half-lives), severe cardiovascular conditions (QTc>450/470ms, NYHA&ge;II), active infections (HIV/HBV/HCV), uncontrolled effusions, prior topoisomerase I inhibitor ADCs, or CNS metastases. Reproductive precautions are mandatory.

The Phase Ib study determines the Recommended Phase II Dose (RP2D) of BL-M07D1 based on integrated safety, tolerability, efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) data over 24 months. Phase II primarily evaluates Objective Response Rate (ORR) per RECIST 1.1, defined as the proportion of participants achieving complete response (CR) or partial response (PR).

Safety and efficacy outcomes include Treatment-Emergent Adverse Events (TEAEs, assessing type/frequency/severity over 24 months), ORR, Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS), and pharmacokinetic metrics (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough). Anti-drug antibody (ADA) frequency and titer are monitored to evaluate immunogenicity.

Eligibility includes HER2-positive gastric/gastroesophageal junction adenocarcinoma patients (&ge;18 years, ECOG 0-1) with &ge;1 measurable lesion (RECIST v1.1), adequate organ function (LVEF&ge;50%), and managed toxicity (&le;CTCAE grade 1). Exclusions: recent antitumor therapy (<4 weeks), severe cardiovascular conditions, active metastases, significant effusions, uncontrolled infections, autoimmune diseases, or prior topoisomerase I inhibitor ADC treatment. Strict contraception and pregnancy testing are required.

Key secondary endpoints include Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), and Treatment-Emergent Adverse Events (TEAEs), all assessed over 24 months. TEAEs monitoring includes evaluating type, frequency, and severity of adverse changes during BL-M07D1 treatment, providing essential safety data for therapeutic assessment.

Eligible participants must be females aged 18-75 with recurrent/metastatic HER2-positive/low-expression gynecologic malignancies, measurable lesions per RECIST 1.1, ECOG 0-1, and adequate organ function. Exclusions include prior topoisomerase I inhibitor ADC therapy, uncontrolled cardiovascular disease, active infections, CNS metastases, recent clinical trial participation, pregnancy/lactation, or conditions deemed unsuitable by investigators.

In Phase Ib, the Recommended Phase II Dose (RP2D) will be determined based on safety, tolerability, efficacy, PK, and PD data from the dose escalation study of BL-M07D1. In Phase II, the Objective Response Rate (ORR) will measure the percentage of participants achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria over approximately 24 months.

Treatment-Emergent Adverse Events (TEAEs) will be monitored for changes in body structure, function, or chemistry during BL-M07D1 treatment. Secondary endpoints include ORR, Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS), pharmacokinetic parameters (Cmax, Tmax, Ctrough), and anti-drug antibody (ADA) frequency over approximately 24 months.