DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
PHASE2RECRUITING
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT06953089
Intervention or treatment
DRUG: DB-1311/BNT324
DRUG: BNT327
DRUG: DB-1305/BNT325
Conditions
- Solid Tumors
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
AUS07-0
Select from list below to view details:
AUS07-0
North Sydney, New South Wales, Australia
AUS06-0
Benowa, Queensland, Australia
AUS04-0
Birtinya, Queensland, Australia
AUS05-0
Adelaide, South Australia, Australia
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Who is running the clinical trial?
DI
DualityBio Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapy
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy
| Drug: DB-1311/BNT324, Drug: DB-1305/BNT325 |
EXPERIMENTAL: Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325
| Drug: DB-1311/BNT324, Drug: DB-1305/BNT325 |
EXPERIMENTAL: Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapy
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327
| Drug: DB-1311/BNT324, Drug: BNT327 |
EXPERIMENTAL: Part 2 Arm 10: RP2D of DB-1311/BNT324 + BNT327
| Drug: DB-1311/BNT324, Drug: BNT327 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of participants with Dose Limiting Toxicities (DLTs). | Not Specified | During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days |
| Part 1: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) | Not Specified | up to follow up period, e.g. up to 72 months. |
| Part 2: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) [By arm and dose level] | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 2: Objective response rate (ORR), defined as the proportion of participants in whom a confirmed Complete response (CR) or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment)by arm and dose level. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment). | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Duration of response (DoR) per RECIST 1.1 based on the investigator's assessment. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Overall survival (OS) | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Disease-control rate (DCR) per RECIST 1.1 based on the investigator's assessment. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Time to response (TTR) per RECIST 1.1 based on the investigator's assessment. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Progression-free survival (PFS) per RECIST 1.1 based on the investigator's assessment. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with platinum-resistant ovarian cancer (PROC). | Not Specified | From the time of initiation of the first dose of IMP to end of Part 1 |
| Part 1: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with PROC. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 2:Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Maximum observed concentration (Cmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Maximum observed concentration (Cmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Time to reach maximum observed concentration (Tmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Time to reach maximum observed concentration (Tmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Terminal elimination half-life (t1/2) of DB-1311/BNT324 total ADC, total antibody and unconjugated P1021 in combination with BNT327. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Terminal elimination half-life (t1/2) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and 2: Anti-drug antibody (ADA) prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline). | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
| Part 1 and Part 2: ADA incidence: the proportion of participants having treatment-emergent ADA. | Not Specified | From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months |
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References
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