Clinical trial for Solid Tumors
Official title DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06953089
What this study is testing
What is DB-1311/BNT324?
This is an investigational medicine being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how the drug combinations work in patients with advanced or metastatic solid tumors.
- Who it's for
- Adults with advanced or metastatic solid tumors who can take the study drugs.
- What's involved
- Participants will receive DB-1311 together with either BNT327 or DB-1305 and will have regular clinic visits and medical tests to monitor safety and effectiveness.
- Time commitment
- The study lasts for several months, with scheduled visits and tests throughout the treatment period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
You likely can't join if
- 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...
- Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits...
- Has uncontrolled or significant cardiovascular disease. Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring...
- Has a history of (non-infectious) ILD/pneumonitis.
See the full eligibility 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 CC with squamous cell, adenocarcinoma, or adenosquamous histology
- For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic/stage IV melanoma.
- For PROC patients (Part 1, Cohort 1A): Participants must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous histology.
- 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...
- For NSCLC patients: Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSQ NSCLC.
- For PSOC (Part 2 Arm 6 only): 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 (Part 2 Arm 7 only): Participants with advanced/unresectable metastatic PDAC without AGA who have progressed after only one prior line of standard systemic treatments (2L PDAC without AGA), or participants with...
- 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 (Part 2 Arm 9 only): Participants with advanced/unresectable mCRC without AGA who have progressed after only one prior line of standard systemic treatment (2L mCRC without AGA), or participants with AGA who...
- For mCRPC (Part 2 Arm 10 only): Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and mCRPC Key
- 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...
- 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...
- 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.
- Other protocol defined inclusion and exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Wheat Ridge, Colorado, United States
- Florida City, Florida, United States
- Atlanta, Georgia, United States
- Bethesda, Maryland, United States
- Lincoln, Nebraska, United States
- New York, New York, United States
- Portland, Oregon, United States
- Charleston, South Carolina, United States
- Anderson, Texas, United States
- Houston, Texas, United States
- Virginia Beach, Virginia, United States
- Puyallup, Washington, United States
- Spokane, Washington, United States
- North Sydney, New South Wales, Australia
- Benowa, Queensland, Australia
- Birtinya, Queensland, Australia
- Adelaide, South Australia, Australia
- Beijing, Beijing Municipality, China
- Dongguan, Guangdong, China
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Wheat Ridge, Colorado, United States; Florida City, Florida, United States; Atlanta, Georgia, United States; Bethesda, Maryland, United States; Lincoln, Nebraska, United States and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.