[M23-385]A Phase 1 study of ABBV-706 alone or in combination in adult subjects with advanced solid tumors.

JRCT ID: jRCT2031230510

Registered date:13/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced solid tumors with potential SEZ6 expression
• Date of first enrollment: 01/12/2023
• Target sample size: 350
• Countries of recruitment: United States,Japan,Israel,Japan,Korea,Japan
• Study type: Interventional

Intervention(s)

drug ABBV-706 IV
drug cisplatin IV
drug budigalimab IV, other name ABBV-181
drug carboplatin IV

Outcome(s)

Primary Outcome

Percentage of Participants With Adverse Events (AE)
Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-706
Time to Cmax (Tmax) of ABBV-706
Terminal Phase Elimination Half-Life (t1/2) of ABBV-706
Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-706
Antidrug Antibodies (ADAs)
Neutralizing Antibodies (nAbs)
Percentage of Participants with Objective Response, for Participants with Extracranial Solid Tumors
Recommended Phase 2 Dose (RP2D) of ABBV-706
Percentage of Participants with Objective Response for Participants with Central Nervous System (CNS) Tumors
Duration of response (DOR) for Participants with Confirmed CR/PR
Percentage of Participants with Clinical Benefit
Progression-Free Survival (PFS)
Overall survival (OS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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: Participants with R/R SCLC following at least 1 prior platinum-containing chemotherapy or R/R poorly differentiated NECs, e.g., NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant Non-small cell lung cancer (NSCLC), atypical lung carcinoids, other high-grade poorly differentiated NECs.
Part 3b only: Participants with R/R SCLC who have only progressed following a frontline regimen containing a platinum-based chemotherapy or R/R NECs, e.g., NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, atypical lung carcinoids, other NECs.
Part 4a only: Participants with R/R 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) who have progressed on SoC therapy and with no curative therapy options available.
Part 4b only: Participants with R/R neuroendocrine tumors, including NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, atypical lung carcinoids, and other high-grade poorly differentiated NECs, who have progressed on SoC therapy and with no curative therapy options available.
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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Yamagishi Chika
• Secondary ID(s): NCT05599984