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New treatment option for Advanced Solid Tumors
Official title A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05914116
What this study is testing
What is DB-1311?
DB-1311 is an investigational medicine, given as an infusion into a vein, 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
- This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
- 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
- Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed...
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic...
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1...
- Has a life expectancy of ≥ 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
You likely can't join if
- Unless otherwise specified, the exclusion criteria are common to both Phase 1 and Phase 2a. people who meet any of the following criteria will be...
- Prior treatment with B7-H3 targeted therapy.
- Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).
- Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia...
- Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
- Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) in males and females based on a 12-lead...
See the full eligibility criteria
Who can join
- Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment; or for which no...
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria (measurable disease as defined by RANO 2.0 criteria for GBM people)...
- Has a life expectancy of ≥ 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
- Has adequate organ function within 7 days prior to Day 1 of Cycle 1
- Has adequate treatment washout period prior to Day 1 of Cycle 1
- Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of B7-H3 level and other biomarkers if no contraindication. Note: there is no minimum B7-H3 expression level...
- Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.
- Male and female people of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months...
- Male people must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration.
- Female people must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
- SCLC people (Phase 2a Cohort 1 ONLY):
- Pathologically documented locally advanced, or metastatic SCLC not amenable to curative surgery or radiation.
- Prior therapy with at least one platinum-based line as systemic therapy for extensive stage disease with at least two cycles of therapy (except in the case of early objective PD).
- Prior treatment regimens with irinotecan, topotecan or any other TOP I inhibitor including investigational TOP I inhibitors are not allowed.
- NSCLC people (Phase 2a Cohort 2 ONLY):
- Pathologically documented locally advanced, or metastatic NSCLC and is not amenable to curative surgery or radiation.
- Has received prior treatment with platinum-based chemotherapy regimen and/or anti-PD-1/PD-L1 antibody-based regimen in the advanced/unresectable, or metastatic setting unless unable or unwilling. people with NSCLC known...
- ESCC people (Phase 2a Cohort 3 ONLY):
- Pathologically documented locally advanced, or metastatic ESCC and is not amenable to curative surgery or radiation.
- Having received at least one prior therapy for unresectable disease. Patients with recurrence within 6 months of completion of neoadjuvant or adjuvant therapy will be considered as having received one prior therapy for...
- CRPC people (Phase 2a Cohort 4 ONLY):
- Pathologically documented metastatic adenocarcinoma of the prostate cancer.
- Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease as defined by PCWG3 criteria.
- Having received prior docetaxel (before or after an AR-targeted therapy). Docetaxel rechallenge was allowed.
- Having received prior novel hormone therapy.
- Melanoma people (Phase 2a Cohort 5 ONLY) Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy, must have had either: \> Previously treated...
- HCC people (Phase 2a Cohort 6 ONLY)
- Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria (fibrolamellar HCC, sarcomatoid HCC, or mixed...
- Has received 1 or 2 prior systemic therapy regimens for recurrent or metastatic disease;
- Has experienced disease progression during or after treatment with an anti-PD-1/L1 agent administered either as monotherapy or in combination. Note: people basically should receive prior standard therapy.
- However, if the investigator judges the therapy is not appropriate for the subject, the prior standard therapy is not necessarily mandated for the eligibility.
- Has a Child-Pugh class A liver score within 7 days of first dose of study drug.
- Cervical cancer people (Phase 2a Cohort 7 ONLY) Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and:
- Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: d. paclitaxel + cisplatin + bevacizumab +...
- Has received 1 or 2 prior systemic therapy regimens for recurrent or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be...
- people with other solid tumors (Phase 2a Cohort 8 ONLY) Histologically or cytologically confirmed solid tumors. Progressed or relapsed after at least one prior standard therapeutic regimen (Patients who have not...
- HNSCC people (Phase 2a Cohort 9 and Cohort 13)
- Histologically or cytologically confirmed refractory/metastatic (R/M) HNSCC (not including NPC) that is considered incurable by local therapies.
- Progressed on or after prior standard therapeutic regimen.
- people with rare tumors (Phase 2a Cohort 10 ONLY) Histologically or cytologically confirmed rare tumor types. Progressed or relapsed after at least one prior standard therapeutic regimen (Patients who have not received...
- Post lutetium-177 CRPC people (Phase 2a Cohort 11 ONLY): Pathologically documented metastatic adenocarcinoma of the prostate cancer. Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone \< 50...
- Taxane-naive CRPC people (Phase 2a Cohort 12, 16, 17 ONLY)
- Pathologically documented metastatic adenocarcinoma of the prostate cancer. Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease as defined by PCWG3...
- people must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous or endometrioid histology..
- people must have platinum-resistant disease:
- Received at least 1 but ≤ 3 lines of prior systemic anticancer therapy and have radiographic progressed on or after their most recent line of therapy. 27\. CSPC with suboptimal PSA response (Phase 2a Cohort 18 ONLY)
- Pathologically documented adenocarcinoma of the prostate cancer.
- Having advanced/unresectable, or metastatic disease and confirmed by imaging (e.g., CT and/or bone scan).
- Having received ADT and enzalutamide or abiraterone for ≥4 months, with suboptimal PSA response. 28\. Additional for DDI cohort: has a study treatment expectancy of \>= 2.5 months. Able to withhold CYP3A/P-gp/OATP1B...
What rules you out
- Unless otherwise specified, the exclusion criteria are common to both Phase 1 and Phase 2a. people who meet any of the following criteria will be excluded from the study:
- Prior treatment with B7-H3 targeted therapy.
- Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).
- Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
- Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
- Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.
- Use of concomitant medications known to prolong the QT interval. If the use is deemed necessary, they should be administered with caution and closely monitoring the QT interval, after discussed with the Sponsor.
- Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are...
- Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically...
- Clinically significant gastrointestinal disorder including, but not limited to, history of gastrointestinal fistulation that need long-term intravenous nutrition; gastrointestinal dysfunction that need long-term enteral...
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding; A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study...
- Metastatic disease that involves major airways or blood vessels (e.g., patients with vascular invasion of the major portal vein and inferior vena cava).
- Clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to the enrollment.
- Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjögren's, sarcoidosis) where there is documented, or a suspicion of pulmonary involvement at the time of screening.
- Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
- Know human immunodeficiency virus (HIV) infection.
- people have active viral (any etiology) hepatitis are excluded. However, people with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen [HBsAg] test or a...
- Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days prior to enrollment.
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms...
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, grade ≤ 1 or baseline. people with chronic Grade 2 toxicities (e.g...
- Has multiple primary malignancies within 3 years before enrollment, except adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer), curatively treated in-situ disease (e.g...
- Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation or evaluation of the clinical study in the opinion of the investigator.
- Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- Patients with other reasons that, in the opinion of the Investigator, make them unsuitable to participate in this study.
- Additional exclusion criteria for DDI cohort: Has a contraindication for receiving lopinavir, ritonavir or itraconazole according to the prescribing information is not able to take lopinavir, ritonavir or itraconazole...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- Celebration, Florida, United States
- Margate, Florida, United States
- Orlando, Florida, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- Detroit, Michigan, United States
- Saint Paul, Minnesota, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Canton, Ohio, United States
- Cincinnati, Ohio, United States
- Dayton, Ohio, United States
- Charleston, South Carolina, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
+ 45 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 - 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?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; Santa Monica, California, United States; Celebration, Florida, United States; Margate, Florida, United States; Orlando, Florida, United States and 59 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.