DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
About this study
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
- Condition
- Solid Tumors
- Tested
- DB-1311/BNT324, BNT327, DB-1305/BNT325
- Sponsor
- DualityBio Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 21
- Minimum age: 18 years
- Study condition: Solid Tumors
- 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
- For PSOC: Must have PSOC, defined as radiographically documented disease recurrence or progression occurring \>6 months after completion of the last dose of platinum-based chemotherapy.
- For PDAC: Participants must have histologically or cytologically confirmed metastatic PDAC., who have progressed after at least one prior line of standard systemic treatment ((≥2L PDAC).)
- For breast cancer:
- HR+/HER2-low or HR+/HER2-ultralow or HR+/HER2-negative BC participants: Pathologically or cytologically documented HR-positive unresectable or metastatic BC with HER2-low, HER2-ultralow or HER2-negative expression.
- Triple negative breast cancer (TNBC): Pathologically or cytologically documented unresectable or metastatic TNBC
- For mCRC: Participants who have metastatic CRC and have relapsed or progressed after 1 prior line of systemic treatment including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or have relapsed or progressed after 2 lines of therapy if the participant has received targeted therapy
- For mCRPC: Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and mCRPC
Exclusion 9
- 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.
Where
37 sites, 37 recruiting
AUS05-0
Adelaide, South Australia, Australia
AUS06-0
Benowa, Queensland, Australia
AUS04-0
Birtinya, Queensland, Australia
AUS07-0
North Sydney, New South Wales, Australia
CHN02-0
Beijing, Beijing Municipality, China
CHN13-0
Beijing, Beijing Municipality, China
and 31 more sites on ClinicalTrials.gov
Contact
-
Jay Ma
540-808-3925 jay.ma@dualitybiologics.com
-
Qiaoli Jiang
+86-15210642683 qiaoli.jiang@dualitybiologics.com
Potential match only. Final eligibility is determined by the study team.