Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors
Advanced Solid Tumors
About this trial
This is an interventional treatment trial for Advanced Solid Tumors focused on measuring Advanced Solid Tumors, Small Cell Lung Cancer, Central Nervous System Tumors, ABBV-706, ABBV-181, Budigalimab, Platinum Chemotherapy Combination, Carboplatin, Cisplatin, Neuroendocrine Carcinomas, Cancer
Eligibility Criteria
Inclusion 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. Exclusion 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.
Sites / Locations
- Yale School of Medicine /ID# 246647Recruiting
- START Midwest /ID# 251257Recruiting
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303Recruiting
- University Hospitals Cleveland Medical Center Seidman Cancer Center /ID# 246641Recruiting
- Tennessee Oncology, PLLC /ID# 246283Recruiting
- University of Texas MD Anderson Cancer Center /ID# 246287Recruiting
- South Texas Accelerated Research Therapeutics /ID# 248946Recruiting
- The Chaim Sheba Medical Center /ID# 254915
- Rambam Health Care Campus /ID# 255059
- National Cancer Center /ID# 248938Recruiting
- Chonnam National University Hwasun Hospital /ID# 248943Recruiting
- CHA University Bundang Medical Center /ID# 248939Recruiting
- Seoul National University Hospital /ID# 248940Recruiting
- Samsung Medical Center /ID# 248936Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Part 1: ABBV-706 Monotherapy Dose Escalation
Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion
Part 3a: ABBV-706 + Budigalimab
Part 3b: ABBV-706 + Platinum Chemotherapy
Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors
Part 4b: ABBV-706 Monotherapy Dose Expansion NECs
Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 1 year treatment period.
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 1 year treatment period.
Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 1 year treatment period.
Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 1 year treatment period.
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 1 year treatment period.
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 1 year treatment period.