DB-1311 in Combination With BNT327 or DB1305 in Advanced/Metastatic Solid Tumors

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and tolerability of 2 experimental drug combinations in people who have been diagnosed with an advanced/metastatic (cancer that has spread from where it started) solid tumor. The drugs being studied are DB-1311, BNT327, and DB-1305. DB-1311 and DB-1305 are antibody drug conjugates (targeted cancer therapies). BNT327 is a bispecific antibody, which means it is designed to bind to 2 different targets (proteins on cancer cells or their surrounding area) and aims to reduce factors that allow cancer cells to grow and spread. In part 1 of the study, participants will receive DB-1311 in combination with BNT327, or DB-1311 in combination with DB-1305. Part 2 includes 5 different treatment groups. The study also will measure the amount of the drugs in the patient’s blood at various time points and determine whether antibodies (proteins in the blood) against the study drug(s) are produced in the body. In addition, the study may explore the relationship between biomarkers (a biological molecule found in blood or tissue that may be a sign of a disease) in the body and the effect of the study drug(s) on the patient’s disease.

Eligibility

* 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

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.

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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute : Marquis Keene, Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB1305 in Participants with Advanced/Metastatic Solid Tumors

Study Details

Disease Type/Condition

Anus, Breast, Cervix, Colon, Esophagus, Lip, Oral Cavity and Pharynx, Liver, Melanoma, Other Female Genital, Other Hematopoietic, Ovary, Unknown Sites

Principal Investigator

Hamid, Omid

Co-Investigators

Cathie T Chung, Erwin Grussie, Inderjit Mehmi, Iryna Singh, Justin Moyers, Kristopher Wentzel

Age Group

Adult

Phase

IRB Number

STUDY00004200

ClinicalTrials.gov ID

NCT06953089

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org