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 Clinical Trial Results and Information

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

ClinicalTrials.gov processed this data on August 26, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified August 2024 by AbbVie

Sponsor

AbbVie

Information Provided by (Responsible Party)

AbbVie

Clinicaltrials.gov Identifier

NCT05599984
Other Study ID Numbers: M23-385
First Submitted: October 28, 2022
First Posted: October 31, 2022
Last Update Posted: August 27, 2024
Last Verified: August 2024
History of Changes

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Study Description

Not Provided

Condition or Disease	Intervention/Treatment
Advanced Solid Tumors	Drug: ABBV-706 Drug: Cisplatin Drug: Budigalimab Drug: Carboplatin

Study Design

Study Type	Interventional
Anticipated Enrollment	350 participants
Design Allocation	Non-Randomized
Interventional Model	Sequential Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Official Title	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
Study Start Date	December 5, 2022
Anticipated Primary Completion Date	October 15, 2025
Anticipated Study Completion Date	May 17, 2027

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Part 1: ABBV-706 Monotherapy Dose Escalation Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 1 year treatment period.	Drug: ABBV-706 Intravenous (IV) Infusion
Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion 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..	Drug: ABBV-706 Intravenous (IV) Infusion
Part 3a: ABBV-706 + Budigalimab Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 1 year treatment period.	Drug: ABBV-706 Intravenous (IV) Infusion Drug: Budigalimab
Part 3b: ABBV-706 + Platinum Chemotherapy Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 1 year treatment period.	Drug: ABBV-706 Intravenous (IV) Infusion Drug: Cisplatin Drug: Carboplatin
Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors 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.	Drug: ABBV-706 Intravenous (IV) Infusion
Part 4b: ABBV-706 Monotherapy Dose Expansion NECs 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.	Drug: ABBV-706 Intravenous (IV) Infusion

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Adverse Events (AE) [Up to Approximately 2 Years]
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-706 [Up to Approximately 2 Years]
Maximum observed serum/plasma concentration of ABBV-706.
Time to Cmax (Tmax) of ABBV-706 [Up to Approximately 2 Years]
Time to Cmax of ABBV-706.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-706 [Up to Approximately 2 Years]
Terminal phase elimination half-life (t1/2) of ABBV-706.
Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-706 [Up to Approximately 2 Years]
Area under the serum/plasma concentration-time curve of ABBV-706.
Antidrug Antibodies (ADAs) [Up to Approximately 2 Years]
Incidence and concentration of anti-drug antibodies.
Neutralizing Antibodies (nAbs) [Up to Approximately 2 Years]
Incidence and concentration of neutralizing antibodies.
Percentage of Participants with Objective Response, for Participants with Extracranial Solid Tumors [Up to Approximately 2 Years]
Objective response is defined as participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 for for extracranial solid tumors per investigator assessment.
Recommended Phase 2 Dose (RP2D) of ABBV-706 [Up to Approximately 2 Years]
The RP2D will be determined using all available information, including, but not limited to, AEs, dose-limiting toxicities, pharmacokinetic parameters, clinical laboratory tests, and efficacy measures.
Percentage of Participants with Objective Response for Participants with Central Nervous System (CNS) Tumors [Up to Approximately 2 Years]
Objective response is as participants achieving a confirmed best overall response of CR and PR according to Response Assessment for Neuro-Oncology (RANO), version 1.1 for CNS tumors per investigator assessment.
Duration of response (DOR) for Participants with Confirmed CR/PR [Up to Approximately 2 Years]
For participants achieving a confirmed CR/PR, DOR is defined as the time from the initial response of CR/PR to disease progression or death of any cause, whichever occurs earlier.
Percentage of Participants with Clinical Benefit [Up to Approximately 2 Years]
Clinical benefit is defined as a participant achieving CR/PR, or Stable Disease (SD).
Progression-Free Survival (PFS) [Up to Approximately 2 Years]
PFS is defined as time from first study treatment to a documented disease progression, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Overall survival (OS) [Up to Approximately 2 Years]
OS is defined as time from first study treatment to death due to any cause.

Eligibility Criteria

Ages Eligible for Study	18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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.

Contacts and Locations

Sponsors and Collaborators	AbbVie
Locations	Banner MD Anderson Cancer Ctr /ID# 260129 \| Gilbert, Arizona, United States, 85234 City Of Hope Comprehensive Cancer Center /ID# 271295 \| Duarte, California, United States, 91030 City of Hope Orange County Lennar Foundation Cancer Center /ID# 259884 \| Irvine, California, United States, 92618 Yale New Haven Hospital /ID# 246647 \| New Haven, Connecticut, United States, 06510 Georgetown University Hospital /ID# 255352 \| Washington, District of Columbia, United States, 20007 University of Chicago /ID# 256334 \| Chicago, Illinois, United States, 60637 Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130 \| Fort Wayne, Indiana, United States, 46804 University of Iowa Hospitals and Clinics /ID# 246638 \| Iowa City, Iowa, United States, 52242 Barbara Ann Karmanos Cancer In /ID# 261799 \| Detroit, Michigan, United States, 48201 Henry Ford Hospital /ID# 246648 \| Detroit, Michigan, United States, 48202 START Midwest /ID# 251257 \| Grand Rapids, Michigan, United States, 49546-7062 St. Luke's Hosp. of Kansas City /ID# 259958 \| Kansas City, Missouri, United States, 64111 Washington University-School of Medicine /ID# 246286 \| Saint Louis, Missouri, United States, 63110 Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303 \| New York, New York, United States, 10065-6007 Duke Cancer Center /ID# 246285 \| Durham, North Carolina, United States, 27710 UH Cleveland Medical Center /ID# 246641 \| Cleveland, Ohio, United States, 44106 Univ Oklahoma HSC /ID# 250884 \| Oklahoma City, Oklahoma, United States, 73117 Tennessee Oncology, PLLC /ID# 246283 \| Nashville, Tennessee, United States, 37203 University of Texas MD Anderson Cancer Center /ID# 246287 \| Houston, Texas, United States, 77030 South Texas Accelerated Research Therapeutics /ID# 248946 \| San Antonio, Texas, United States, 78229 University of Utah /ID# 246640 \| Salt Lake City, Utah, United States, 84112-5500 Northwest Medical Specialties - Tacoma /ID# 262801 \| Tacoma, Washington, United States, 98405 Chris O'Brien Lifehouse /ID# 259087 \| Camperdown, New South Wales, Australia, 2050 The Kinghorn Cancer Centre /ID# 260874 \| Darlinghurst, New South Wales, Australia, 2010 Austin Health and Ludwig Institute for Cancer Research /ID# 255174 \| Heidelberg, Victoria, Australia, 3084 Peter MacCallum Cancer Ctr /ID# 259197 \| Melbourne, Victoria, Australia, 3000 Institut Régional du Cancer Montpellier /ID# 265086 \| Montpellier, France, 34298 Technische Universitat Dresden /ID# 259414 \| Dresden, Germany, 01307 Rambam Health Care Campus /ID# 255059 \| Haifa, H_efa, Israel, 3109601 The Chaim Sheba Medical Center /ID# 254915 \| Ramat Gan, Tel-Aviv, Israel, 5265601 Hadassah Medical Center-Hebrew University /ID# 255147 \| Jerusalem, Israel, 91120 National Cancer Center Hospital East /ID# 259417 \| Kashiwa-shi, Chiba, Japan, 277-8577 National Hospital Organization Shikoku Cancer Center /ID# 261279 \| Matsuyama-shi, Ehime, Japan, 791-0280 Hokkaido Cancer Center /ID# 261278 \| Sapporo-shi, Hokkaido, Japan, 003-0804 Kyoto University Hospital /ID# 259419 \| Kyoto-shi, Kyoto, Japan, 606-8507 Shizuoka Cancer Center /ID# 261277 \| Sunto-gun, Shizuoka, Japan, 411-8777 National Cancer Center Hospital /ID# 259418 \| Chuo-ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JFCR /ID# 260132 \| Koto-ku, Tokyo, Japan, 135-8550 Wakayama Medical University Hospital /ID# 260131 \| Wakayama-shi, Wakayama, Japan, 641-8510 National Cancer Center /ID# 248938 \| Goyang-si, Gyeonggido, Korea, Republic of, 10408 CHA Bundang Medical Center /ID# 248939 \| Seongnam, Gyeonggido, Korea, Republic of, 13496 Chonnam National University Hwasun Hospital /ID# 248943 \| Hwasun-gun, Jeonranamdo, Korea, Republic of, 58128 Seoul National University Hospital /ID# 248940 \| Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080 Samsung Medical Center /ID# 248936 \| Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351 Yonsei University Health System Severance Hospital /ID# 248937 \| Seoul, Korea, Republic of, 03722 Hospital HM Nou Delfos /ID# 264851 \| Barcelona, Spain, 08023 Hospital Universitario Vall d'Hebron /ID# 258659 \| Barcelona, Spain, 08035 Hospital Universitario Ramon y Cajal /ID# 257291 \| Madrid, Spain, 28034 Hospital Universitario Fundacion Jimenez Diaz /ID# 257295 \| Madrid, Spain, 28040 Hospital Universitario 12 de Octubre /ID# 258658 \| Madrid, Spain, 28041 Hospital Universitario HM Sanchinarro /ID# 258657 \| Madrid, Spain, 28050 Hospital Universitario Virgen del Rocio /ID# 256940 \| Sevilla, Spain, 41013 Hospital Clinico Universitario de Valencia /ID# 257290 \| Valencia, Spain, 46010
Investigators