2025-523895-22-00招募中2 期
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 23
- 主要终点
- Part 1: Number of participants with Dose Limiting Toxicities (DLTs)
研究概览
简要总结
Part 1:
- To determine the RP2D of DB-1311 in combination with BNT327 by assessing the safety and tolerability in targeted participant populations.
- To determine the RP2D of DB-1311 in combination with DB-1305 by assessing the safety and tolerability in targeted participant populations.
Part 2: 3. Arms 1-4: To assess the efficacy of DB-1311 in combination with BNT327 in targeted participant populations. 4. Arm 4: To determine the optimal dose of DB-1311 in combination with BNT327 by assessing the safety profile and efficacy of the combination therapy in the randomized dose optimization arm. 5. Arm 5: To determine the optimal dose of DB-1311 in combination with DB-1305 by assessing the safety profile and efficacy of the combination therapy in the randomized dose optimization arm and to assess the efficacy of DB-1311 in combination with DB-1305 in targeted participant populations.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent
- •Are POCBP who agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial, starting at the time of giving informed consent and continuously until 8 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.
- •Are males who are fertile or if they are potentially fertile (i.e., are not surgically [e.g., have had a vasectomy] or congenitally sterile) and sexually active with a partner of childbearing potential, who agree to use condoms and to ask their female sexual partners to practice a highly effective form of contraception during the trial, starting at the time of giving informed consent and continuously until 5 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.
- •Are potentially fertile males who are willing to refrain from sperm donation, starting at the time of giving informed consent and continuously until 5 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.
- •Please see Section 5.3 of the protocol for additional Cohort/Arm-specific inclusion criteria.
- •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 (see Section 8.4.3 of the protocol for details).
- •Has adequate organ function within 7 days prior to enrollment/randomization, as defined in Section 5.3 of the protocol.
- •Has adequate treatment washout period prior to the first dose of trial treatment, as defined in Section 5.3 of the protocol. Previous effective treatment will not be discontinued due to study participation.
- •Is capable of comprehending trial procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the trial and the schedule of assessments.
- •Are POCBP (participant of childbearing potential) who have a negative serum beta-hCG pregnancy test.
- •Are POCBP who agree to practice a highly effective form of contraception and to require their male partners to use condoms starting at the time of giving informed consent and continuously until 8 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.
排除标准
- •Prior treatment with B7H3 targeted therapy.
- •Has a medical, psychological, or social condition or substance abuse which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol-described requirements.
- •Is vulnerable individual as per ICH E6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. This includes all sponsor, trial site, or third party (e.g., CRO, vendor) personnel directly involved in the conduct of the trial and their family members or dependents, as well as all trial site personnel otherwise supervised by the investigator.
- •Please see Section 5.4 of the protocol for additional Cohort/Arm-specific exclusion criteria.
- •Prior treatment with antibody-drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).
- •Is a candidate to locoregional treatment (including surgical resection, stereotactic radiation therapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as “radical” intent), 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, including conditions specified in Section 5.4 of the protocol.
- •Has uncontrolled or significant disease or disorder, or history of specific diseases and disorders, as detailed in Section 5.4 of the protocol.
- •Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline. Toxicities that have resolved with sequelae (e.g., tracheostomy, chronic use of feeding tube, replacement hormones) are allowed, if not associated with increased risk of complications per investigator’s assessment.
- •Has a history of allergies, hypersensitivities, or intolerance to the trial treatments including any excipients thereof.
- •Has a history of another primary malignancy within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated or have a known additional malignancy that is progressing or requires treatment.
- •Use of any IMP within 28 days or five half-lives if known (whichever is longer) before administration of first dose of trial treatment or ongoing participation in the active treatment phase of another interventional clinical trial or prior randomization or treatment in a previous trial with the same IMPs as the current trial, regardless of treatment assignment.
研究组 & 干预措施
BNT327
Test
干预措施: BNT327 (Drug)
BNT324
Test
干预措施: BNT324 (Drug)
BNT325/DB-1305
Test
干预措施: BNT325/DB-1305 (Drug)
结局指标
主要结局
Part 1: Number of participants with Dose Limiting Toxicities (DLTs)
Part 1: Number of participants with Dose Limiting Toxicities (DLTs)
Part 1: Treatment emergent adverse events (TEAEs) and treatment emergent serious AE (TESAEs)
Part 1: Treatment emergent adverse events (TEAEs) and treatment emergent serious AE (TESAEs)
Part 2: ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST v1.1 based on the investigator’s assessment).
Part 2: ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST v1.1 based on the investigator’s assessment).
Part 2: Safety and tolerability: TEAEs and TESAEs
Part 2: Safety and tolerability: TEAEs and TESAEs
次要结局
- Part 1: Efficacy evaluations: objective response rate (ORR), defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator’s assessment)
- Part 1: Duration of response (DoR), disease-control rate (DCR), Time to Response (TTR), Progression Free Survival (PFS) will be determined from tumor assessments by Investigator per RECIST v1.1.
- Part 1: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with platinumresistant ovarian cancer (PROC).
- Part 1: Overall Survival (OS)
- Part 1: PK parameters of DB-1311 antibody-drug conjugate (ADC), total antibody, and unconjugated P1021 in combination with BNT327 or in combination with DB-1305.
- Part 1: Anti-drug antibody (ADA) prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of participants having treatment-emergent ADA.
- Part 2: DoR, DCR, TTR, and PFS determined by Investigator as per RECIST v1.1
- Part 2: Safety and tolerability: TEAEs and TESAEs
- Part 2: OS
- Part 2: PK parameters of DB-1311 ADC, total anti-B7H3 antibody, and unconjugated P1021.
- Part 2: ADA prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of participants having treatment-emergent ADA.
研究者
Executive Medical Director
Scientific
Dualitybio Inc.
研究点 (23)
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