Clinical Trial Finder

Inclusion Criteria:

• - Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.

• - At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.

• - Has a life expectancy of ≥ 3 months.

• - Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.

• - Has adequate organ function within 7 days prior to enrollment/randomization, - Has adequate treatment washout period prior to the first dose of trial treatment.

• - For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score.

• - For CC patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology.

• - For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma.

• - For PROC patients (Cohort A): Participants must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous histology.

Patients must have platinum-resistant disease.

• - For HNSCC patients: Histologically or cytologically confirmed recurrent (recurrent disease that is not amendable to curative treatment with local/ or systemic therapies)/ (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.

• - For NSCLC patients: Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSQ NSCLC.

Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations.

Exclusion Criteria:

• - 1.

Prior treatment with B7H3 targeted therapy.

• - Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.

• - Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.

• - Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.

• - Has uncontrolled or significant cardiovascular disease.

Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy.

• - Has a history of (non-infectious) ILD/pneumonitis.

• - Any autoimmune, connective tissue or inflammatory disorders.

• - Has spinal cord compression or clinically active central nervous system (CNS) metastases.

• - Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.

This is a phase II, multicenter, open-label, two-part trial designed to evaluate the safety and preliminary efficacy of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 in targeted participants. Participants with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC), platinum-resistant ovarian cancer (PROC) or non-small cell lung cancer (NSCLC) are eligible to participate in the trial.

Arms

Experimental: Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapy

Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D (Recommended Phase 2 Dose) and RP2D-1 in target population.

Experimental: Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy

Escalating combination dose levels of DB-1311/BNT324 and DB-1305/BNT325 to define RP2D and RP2D-1 in target population.

Experimental: Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/metastatic HCC

Experimental: Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/ metastatic CC

Experimental: Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/metastatic melanoma

Experimental: Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 and RP2D-1 of DB-1311/BNT324 + BNT327

In participants with recurrent/metastatic HNSCC

Experimental: Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325

In participants with advanced/unresectable metastatic NSCLC

Experimental: Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapy

Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D and RP2D-1 in target population.

Interventions

Drug: - DB-1311/BNT324

Administered I.V.

Drug: - BNT327

Administered I.V.

Drug: - DB-1305/BNT325

Administered I.V.