临床试验/NCT05599984

NCT05599984进行中（未招募）1 期

A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors

AbbVie126 个研究点分布在 8 个国家目标入组 288 人开始时间: 2022年12月5日最近更新: 2026年5月7日

适应症

干预措施

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 288
试验地点: 126
主要终点: Percentage of Participants With Adverse Events (AE)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin.

ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 319 adult participants will be enrolled in the study across sites worldwide.

In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 4 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•The laboratory values criteria must be met within 7 days prior to the first dose of study drug as per the protocol.
•QT interval corrected for heart rate (QTc) <= 450 msec (males) or <= 470 msec (females) using Fridericia's correction, and an ejection fraction of >= 50% as measured by echocardiogram or multigated acquisition (MUGA) scan at Screening.
•Part 1 only: Advanced recurrent or refractory solid tumors with potential SEZ6 expression including small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors (glioblastoma [GBM], IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4), neuroendocrine prostate cancer (NEPC), high-grade poorly differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC)s, large cell neuroendocrine carcinoma (LCNEC)s, SCLC transformed from epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC), atypical lung carcinoids, and other high-grade poorly differentiated NECs, who have progressed on or after standard of care (SoC) therapy and with no curative therapy available. For SCLC, participants must have histologically or cytologically confirmed SCLC that is relapsed or refractory following at least 1 prior platinum-containing chemotherapy.
•Part 2 only: Histologically or cytologically confirmed SCLC that is relapsed or refractory (R/R) following at least 1 prior platinum-containing chemotherapy and with no curative therapy available. For the purposes of this study, a line of therapy is defined as >= 1 complete cycle of either a single agent or combination of drugs, including any planned sequential therapy of various regimens.
•Part 3a only: SCLC or Grade 3 NETs and poorly differentiated NECs. Specific tumor types include but not limited to NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, MTC, and other NECs (atypical lung carcinoids that have received prior chemotherapy are allowed)
•Part 3b only: SCLC who have only progressed following a frontline regimen containing a platinum-based chemotherapy (i.e., second-line SCLC subjects) or Grade 3 NETs and poorly differentiated NECs. Specific tumor types include but not limited to NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, MTC, and other NECs (atypical lung carcinoids that have received prior chemotherapy are allowed)tumors (GBM, IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4) who have progressed on SoC therapy and with no curative therapy options available.
•Part 4b only: Grade 3 NETs and poorly differentiated NECs. Specific tumor types include but not limited to NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, MTC, and other NECs (atypical lung carcinoids that have received prior chemotherapy are allowed)
•Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for participants with extracranial solid tumors or Response Assessment for Neuro-Oncology (RANO)for participants with primary high-grade CNS tumors (GBM, IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4).
•Primary CNS tumors within 12 weeks from radiation therapy should have unequivocal progression as documented by either tumor recurrence predominantly outside of radiation field on magnetic resonance imaging (MRI) or confirmed on tumor biopsy.
•Participants with brain metastases from an extracranial solid tumor are eligible if the brain metastases as outlined in the protocol.
•Fresh or archival tumor tissue available for submission, for retrospective SEZ6 expression analysis as outlined in the protocol.

排除标准

•History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
•History of idiopathic pulmonary fibrosis or organizing pneumonia.
•Prior treatment with an antibody drug conjugate that consists of a Top1 inhibitor payload.
•Part 2 only: Prior treatment with a SEZ6-targeted antibody drug conjugate.

研究组 & 干预措施

Part 3a: ABBV-706 + Budigalimab

Experimental

Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 2 year treatment period.

干预措施: Budigalimab (Drug)

Part 3b: ABBV-706 + Platinum Chemotherapy

Experimental

Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 2 year treatment period.

干预措施: Cisplatin (Drug)

Part 3b: ABBV-706 + Platinum Chemotherapy

Experimental

Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 2 year treatment period.

干预措施: Carboplatin (Drug)

Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors

Experimental

Participants with relapsed/refractory (R/R) central nervous system (CNS) tumors will receive ABBV-706 as a monotherapy at or below the maximum tolerated dose (MTD) maximum administered dose (MAD), as part of an approximately 2 year treatment period.

干预措施: ABBV-706 (Drug)

Part 1: ABBV-706 Monotherapy Dose Escalation

Experimental

Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 2 year treatment period.

干预措施: ABBV-706 (Drug)

Part 3b: ABBV-706 + Platinum Chemotherapy

Experimental

Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 2 year treatment period.

干预措施: ABBV-706 (Drug)

Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion

Experimental

Participants with small cell lung cancer will receive varying doses of ABBV-706 in a randomized manner until the recommended phase 2 dose (RP2D) is achieved, as part of an approximately 2 year treatment period..

干预措施: ABBV-706 (Drug)

Part 3a: ABBV-706 + Budigalimab

Experimental

Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 2 year treatment period.

干预措施: ABBV-706 (Drug)

Part 4b: ABBV-706 Monotherapy Dose Expansion NECs

Experimental

Participants with R/R neuroendocrine carcinomas (NECs) will receive IV Infused ABBV-706 as a monotherapy at or below the MTD/MAD, as part of an approximately 2 year treatment period.

干预措施: ABBV-706 (Drug)