Eligible participants (≥18 years, ECOG 0-1) must have advanced solid tumors (e.g., NSCLC, SCLC, PDAC) failing prior therapies, measurable lesions (RECIST v1.1/PCWG3), and adequate organ function (ANC≥1.5×10⁹/L, platelets≥100×10⁹/L, LVEF≥50%). Key exclusions: active CNS metastases, prior same-target therapy, uncontrolled infections (HBV-DNA+/HCV-RNA+), QTcF>450/470ms, immunosuppressive steroid use, or live vaccinations within 4 weeks. NSCLC/SCLC/UC subgroups require prior platinum/ICI failure.

Eligible participants (≥18 years, ECOG 0-1) must have treatment-refractory metastatic solid tumors, adequate organ function, and use contraception. Key exclusions include multiple malignancies (5-year window), recent anti-cancer therapies (chemotherapy within 3 weeks, brain metastases unless stable ≥4 weeks), prior same-target therapy, or unresolved toxicities (>CTCAE grade 1).

Key inclusion criteria: Age 18-75; ECOG 0-1; histologically confirmed advanced/metastatic malignancies refractory to standard therapy; ≥1 measurable lesion; adequate organ function; provision of tumor samples (≥5 slides); negative pregnancy test; commitment to contraception (6 months post-treatment); protocol compliance capability. Survival expectancy ≥3 months.

Key eligibility: Adults (≥18) with advanced solid tumors (RECIST 1.1 measurable, ECOG 0-1) refractory to standard therapies, requiring adequate organ function. Exclusions: active brain metastases, ILD history, prior Trop-2 therapy, or combination-specific contraindications (e.g., cemiplimab hypersensitivity, Grade 3+ immune-related AEs). Pregnancy and recent anticancer therapies/surgeries are prohibited.

Key eligibility: Adults (≥18) with advanced epithelial solid tumors (RECIST 1.1 measurable, ECOG 0-1) refractory to standard therapies, requiring adequate organ function. Exclusions: active infections (HBV/HCV/HIV), severe comorbidities (cardiac/pulmonary/ocular), prior Trop-2/TOP1-ADC therapy, or unresolved Grade 2+ toxicities. Tumor types prioritized include gastric/breast/colorectal cancers.

Eligible patients (aged 18-75, ECOG 0-1) must have advanced solid tumors, measurable lesions per RECIST 1.1, and ≥12-week life expectancy. Exclusions include recent major surgery (within 4 weeks), active CNS metastases, prior malignancies (5 years), steroid use (within 2 weeks), pregnancy/lactation, or conditions compromising study integrity. Contraception is required during and post-treatment.

The primary objectives are to assess DLT (within 21 days of first cycle), determine MTD/RDEs, and monitor AE incidence throughout the trial. Secondary efficacy endpoints include ORR (CR + PR per RECIST 1.1), PFS (time from first dose to PD/death), DoR (response duration from CR/PR to PD), and OS (time from first dose to death), evaluated over 60 months.

Eligible patients are adults (≥18 years) with histologically confirmed advanced/metastatic solid tumors refractory to standard therapy, measurable lesions per RECIST 1.1, ECOG PS 0-1, adequate organ function, and compliance with contraception. Exclusions involve recent experimental/tumor therapy (within 4 weeks), prior Trop2-targeted treatment, severe topoisomerase I inhibitor toxicity, major surgery (within 4 weeks), or organ transplantation history.

Eligible patients are adults (≥18) with advanced/metastatic epithelial solid tumors (e.g., triple-negative breast cancer, NSCLC) refractory to standard therapy, measurable lesions (RECIST 1.1), ECOG PS 0-1, and adequate organ function. Key exclusions: recent experimental/anti-tumor therapy (4 weeks), prior Trop2-ADC/toisomerase I inhibitor toxicity, uncontrolled CNS metastases, active infections (HIV/HBV/HCV), severe cardiovascular disease, or immunosuppressive therapy within 14 days.

Eligible patients (18-75 years) have recurrent/refractory lymphoid malignancies, ECOG&le;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; &ge;18 years, Phase Ib) have incurable metastatic solid tumors, ECOG 0-1, &ge;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.

Eligible patients are aged 18-75 with advanced Trop2-positive epithelial cancer, measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, and recovery from prior therapy (&le;Grade 1 AEs, except alopecia). Exclusion criteria include active HBV/HCV/syphilis, immunodeficiency, uncontrolled infections, severe cardiopulmonary disease, CNS metastases, Grade &ge;2 neuropathy, recent clinical trial participation, major surgery, strong CYP3A4 inhibitor use, allergies, pregnancy, substance abuse, or other investigator-deemed ineligibility.

Eligible patients (18-75 years with ECOG 0-1) must have progressing advanced solid tumors after standard therapy, measurable disease per RECIST 1.1, and adequate organ function. Required fresh/archived tumor tissue within 1 year and recovery of prior treatment toxicities to &le;Grade 1 (excluding alopecia). Women of childbearing potential need negative pregnancy test.

Patients with advanced solid tumors confirmed histologically or cytologically must have received standard treatment, have not responded to standard treatment, or have been intolerant to standard treatment, including, but not limited to, triple-negative breast cancer, cervical cancer, endometrial cancer, ovarian cancer, uroepithelial cancer, pancreatic cancer, esophageal cancer, and non-small cell lung cancer. Triple-negative breast cancer, cervical cancer, ovarian cancer and urothelial carcinoma were included in the dose expansion phase.

This PDX was obtained in accordance with appropriate consent procedures. This ovarian PDX model was subcutaneously passaged in vivo as fragments from animal to animal in nude mice. When tumors reached approximately 250 mm 3 similar-sized tumors were randomly assigned to treatment groups, DS-1062 was administered as a single dose at 10 mg/kg on day 1. Duration of dosing was 21 days. TGI responses (Day 28 TGI%) was measurede.

Female Nude mice (Charles River) aged 5-8 weeks were used, following 7 days acclimatisation before entry into the study. The human patient-derived xenograft (PDX) model, CTG-3303, was established from fragments of freshly resected tumor of a triple negative breast cancer (TNBC) patient whom relapsed on treatment with PARP inhibitor talazoparib. This PDX was obtained in accordance with appropriate consent procedures. This TNBC PDX model was subcutaneously passaged in vivo as fragments from animal to animal in nude mice. When tumors reached approximately 250 mm 3 , similar-sized tumors were randomly assigned to treatment groups. DS-1062 was administered as a single dose at 10 mg/kg on day 1. Duration of dosing schedule was 21 days. TGI responses (Day 46 TGI%) was measurede.

Nude mice (Charles River) aged 5-8 weeks wereused,following 7 days acclimatisation before entry intothe study.5x106 NCI-N87 tumor cells (gastric cancercell line) (1:1 in Matrigel)were implantedsubcutaneously onto the flank of the female Nude mice.When tumors reached approximately 250 mm,similar-sizedtumors were randomly assigned to treatment groups, DS-1062 was administered as a single dose at 10 mg/kg on day 1. Duration of dosing schedule was 21 days.