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 ≥50%, and adequate organ function (INR ≤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 ≥50%, INR ≤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 (≥18 years) with HER2-expressing (IHC 1+/3+ or gene-amplified) advanced/metastatic solid tumors (e.g., endometrial, breast, gastric cancers) refractory to ≥2 prior therapies, measurable lesions (RECIST v1.1), ECOG 0-1, and adequate organ function (LVEF ≥50%, INR/APTT ≤1.5×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 ≥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≥50%, ANC≥1.5×10⁹/L). Exclusions cover recent antitumor therapies (4 weeks/5 half-lives), cardiovascular risks (QTc>450/470ms, NYHA≥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 (≥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≥50%; ANC≥1.5×10⁹/L). Exclusions include recent antitumor therapies (4 weeks/5 half-lives), severe cardiovascular conditions (QTc>450/470ms, NYHA≥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 (≥18 years, ECOG 0-1) with ≥1 measurable lesion (RECIST v1.1), adequate organ function (LVEF≥50%), and managed toxicity (≤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.

Eligible participants (18-75 for Ia, ≥18 for Ib) have advanced/metastatic solid tumors (e.g., gastrointestinal) with ECOG 0-1, adequate organ function (ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, etc.), and measurable lesions (Ib: RECIST 1.1). Exclusions: recent antitumor therapy (4 weeks/5 half-lives), prior TROP2/camptothecin ADCs, severe cardiac/autoimmune disease, uncontrolled infections, CNS metastases (unless stable >1 month), or pregnancy. HIV/HBV/HCV active infections and QTc prolongation (>450/470 msec) also exclude.

Eligible participants (age 18-75 for Phase Ia, ≥18 for Phase Ib) have advanced/metastatic solid tumors, ECOG 0-1, adequate organ function (ANC ≥1.5×10⁹/L, platelets ≥90×10⁹/L), and measurable lesions (Phase Ib). Key exclusions include recent anti-cancer therapy (within 4 weeks/5 half-lives), prior TROP2-ADC treatment, severe cardiac disease (LVEF <50%, QTc >450/470 msec), active CNS metastases (unless stable >1 month), uncontrolled infections (HBV/HCV/HIV), and autoimmune disorders requiring systemic treatment.

Safety assessments include monitoring treatment-emergent adverse events (TEAEs) for 24 months. PK parameters (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough) are measured within 21 days post-dose. Immunogenicity (ADA/Nab) analysis and efficacy evaluation (ORR/DCR per RECIST 1.1, DOR, PFS) continue for approximately 24 months, with response criteria requiring ≥30% tumor reduction for PR or disappearance of lesions for CR.

Eligible patients (≥18 years) have advanced solid tumors (primarily NSCLC) with ECOG 0-1, measurable lesions (RECIST 1.1), and adequate organ function (ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, LVEF ≥50%). Key exclusions include recent anticancer therapy (within 4 weeks/5 half-lives), prior Trop2-ADC treatment, uncontrolled cardiovascular disease (QTc >450/470 msec), active CNS metastases, HIV/HBV/HCV infections, and severe comorbidities. Tumor tissue submission is required unless waived by investigators.

The Phase Ib study establishes the RP2D for BL-M02D1 based on integrated safety, tolerability, efficacy, PK and PD data from dose escalation. The primary Phase II endpoint is ORR (≥30% tumor reduction per RECIST 1.1) assessed over 24 months. Pharmacokinetic analysis investigates Cmax, Tmax, Ctrough, T1/2, AUC0-T and CL during the first 21 days post-dose.

Safety monitoring includes TEAE assessment for 24 months, with efficacy evaluations encompassing DCR (CR+PR+SD), DOR (time to progression/death) and PFS. Immunogenic response is tracked through ADA frequency. Primary endpoints differ between phases: ORR serves as the key efficacy measure in both Phase Ib and II cohorts, while PFS represents a secondary endpoint in Phase II studies following initial RP2D determination.

Eligible patients (18-75 years) have relapsed/refractory AML, ECOG ≤2, and adequate organ function. Exclusions include prior transplants, heart/lung conditions (e.g., QT prolongation, ILD), HIV/HBV/HCV infections, uncontrolled hypertension, autoimmune diseases, recent chemotherapy (<4 weeks), or pregnancy. Investigators may exclude unsuitable candidates.

This study enrolled patients with R/R AML aged 18-75 years. For dose escalation (D-ESC i3+3), BL-M11D1 was administrated intravenously in dose cohorts from 0.6mg/kg up to 4.4mg/kg once a week (QW) in 28-day cycles for induction treatment, followed by administration every two weeks (Q2W) at the same initial dose for consolidation treatment in pts whose bone marrow (BM) blast <5%. A subset of pts were enrolled in dose-expansion (D-EXP) at 1.65, 2.2 mg/kg doses.

Eligible patients (≥18 years) have relapsed/refractory CD33+ AML, ECOG 0-2, adequate organ function, and life expectancy ≥3 months. Exclusions include APL/CML, recent chemotherapy (<2 weeks/5 half-lives), uncontrolled heart disease, active infections, severe lung conditions (ILD), CNS leukemia, pregnancy, or conditions deemed unsafe by investigators. HIV/HBV/HCV-positive patients with detectable viral loads are excluded.

The study evaluates BL-M11D1 safety by monitoring dose-limiting toxicities (DLTs) including severe TEAEs (≥Grade 3), treatment discontinuation events, and hematologic/nonhematologic toxicities over 1 year. Key safety endpoints include determining the maximum tolerated dose (MTD), minimum safe and effective dose (MSED), and assessing serious adverse events (SAEs).

Eligible patients (18-75 years) have recurrent/refractory lymphoid malignancies, ECOG≤2, adequate organ function, and no standard treatment options. Exclusions include recent anticancer therapy (<4 weeks), uncontrolled cardiac/autoimmune diseases, active infections (HIV/HBV/HCV), ILD, CNS involvement, or pregnancy. Archived tumor tissue within 2 years is required.

Eligible patients (18-75 years, Phase Ia; ≥18 years, Phase Ib) have incurable metastatic solid tumors, ECOG 0-1, ≥3-month life expectancy, and measurable lesions. Exclusions include recent anticancer therapy (<4 weeks), uncontrolled cardiovascular disease, active infections (HIV/HBV/HCV), ILD, CNS metastases, organ transplants, or pregnancy. Contraception is required for 6 months post-treatment.

Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, recurrent SCLC after PD-1/PD-L1 and platinum failure, measurable lesion (RECIST v1.1), available tumor tissue (within 3 years), adequate organ function (LVEF≥50%, no transfusion/growth factors within 14 days), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, HER2-negative breast cancer refractory to standard therapy, measurable lesions per RECIST 1.1, adequate organ function (hematologic/renal/hepatic), resolved prior toxicity (≤Grade 1), and contraception compliance. Archived/fresh tumor tissue submission is mandatory unless waived by the sponsor.

Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, HR+HER2- breast cancer (unresectable/metastatic) with 1-2 prior chemotherapy lines and progression after endocrine/CDK4/6/taxane therapy, measurable lesions (RECIST 1.1), adequate organ function, resolved prior toxicity (≤Grade 1), and contraception compliance. Archived/fresh tumor tissue within 3 years required unless exempted.

Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, triple-negative breast cancer (unresectable/metastatic) with 1-2 prior chemotherapy lines including taxanes, measurable lesions (RECIST 1.1), stable treated brain metastases if present, adequate organ function, resolved prior toxicity (≤Grade 1), and contraception compliance. Archived/fresh tumor tissue within 3 years required.

Inclusion criteria: signed consent, age 18-75, ECOG 0-1, treatment-naive triple-negative breast cancer (unresectable/metastatic), measurable lesions (RECIST 1.1), archived/fresh tumor tissue within 2 years, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test for premenopausal women, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age ≥18, KPS≥60, recurrent glioblastoma failing standard therapy, resolved prior toxicity (≤Grade 1), adequate organ function (hematologic/renal/hepatic), LVEF≥50%, negative pregnancy test for premenopausal women, and contraception use during treatment plus 6 months post-treatment. No recent blood products or growth factors within 14 days prior to treatment initiation.

Key inclusion criteria: signed consent, female patients aged 18-75, ECOG 0-1, recurrent/metastatic gynecological malignancies with measurable lesions (RECIST v1.1), available tumor tissue, adequate organ function (LVEF≥50%, urine protein≤2+), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, locally advanced/metastatic GI cancers, measurable lesions (RECIST v1.1), available tumor tissue, adequate organ function (LVEF≥50%, urine protein≤2+), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age 18-75 (Phase Ia) or ≥18 (Phase Ib), ECOG 0-1, advanced/metastatic solid tumors (TNBC or others) failing standard therapy, measurable disease (RECIST v1.1), available tumor tissue (preferred), adequate organ function (hematologic/hepatic/renal), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed recurrent/metastatic esophageal squamous cell carcinoma, measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed recurrent/metastatic esophageal squamous cell carcinoma, measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, recurrent/metastatic gynecological malignancies or other solid tumors failing standard therapy, measurable lesion (RECIST v1.1), available tumor tissue (preferred), adequate organ function (hematologic/hepatic/renal), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed recurrent/metastatic nasopharyngeal carcinoma failing ≥2 prior chemotherapy lines (including platinum), measurable lesion (RECIST v1.1), adequate organ function (hematologic/hepatic/renal), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, histologically confirmed recurrent/metastatic HNSCC (non-nasopharyngeal) or other solid tumors, measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, histologically confirmed locally advanced/metastatic solid tumors (e.g., NSCLC, nasopharyngeal carcinoma), measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed locally advanced/metastatic NSCLC or nasopharyngeal carcinoma, measurable lesion (RECIST v1.1), available tumor tissue (6-10 slides), adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age ≥18, ECOG ≤1, histologically confirmed locally advanced/metastatic NSCLC, measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function (LVEF ≥50%, INR ≤1.5, APTT ≤1.5×ULN, urinary protein ≤2+/1000mg/24h), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use.

Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, histologically confirmed extensive-stage SCLC (Cohort_A: ≥3L treatment failure/intolerance; Cohort_B: 1L failure or treatment-naive), measurable lesion (RECIST v1.1), available tumor tissue (10 slides within 3 years), adequate organ function, negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed EGFR wild-type NSCLC, measurable lesion (RECIST v1.1), available tumor tissue (within 3 years), adequate organ function (LVEF≥50%, urine protein≤2+/<1000mg/24h), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, newly diagnosed extensive-stage SCLC, measurable lesion (RECIST v1.1), available tumor tissue (within 3 years), adequate organ function (no transfusion/growth factors within 14 days), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age ≥18, ECOG ≤1, histologically confirmed EGFR-mutant NSCLC, measurable lesion (RECIST v1.1), available tumor tissue (within 2 years), adequate organ function (LVEF≥50%, INR≤1.5, APTT≤1.5×ULN, urine protein≤2+/≤1000mg/24h), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use (7 days pre-dose to 6 months post-dose).

Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, unresectable/radically irradiated EGFR-mutant NSCLC, measurable lesion (RECIST v1.1), available tumor tissue (post-diagnosis), adequate organ function (LVEF≥50%, urine protein≤2+/<1000mg/24h, no transfusion/growth factors within 14 days), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Key inclusion criteria: signed consent, age 18-75, ECOG ≤2, histologically confirmed unresectable/metastatic chordoma, measurable disease, adequate organ function (LVEF≥50%, INR≤1.5, APTT≤1.5ULN, urine protein≤2+/<1000mg/24h), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

Inclusion criteria: signed consent, age 18-75 (Ia)/≥18 (Ib), ECOG 0-1, advanced/metastatic solid tumors (including breast cancer) refractory to standard therapy, measurable lesion (RECIST v1.1), available tumor tissue (within 3 years, waiver possible), adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.