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 July 3, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified July 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: July 5, 2024
Last Verified: July 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 TypeInterventional
Anticipated Enrollment350 participants
Design AllocationNon-Randomized
Interventional ModelSequential Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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 DateDecember 5, 2022
Anticipated Primary Completion DateOctober 15, 2025
Anticipated Study Completion DateMay 17, 2027

Groups and Cohorts

Group/ CohortIntervention/ 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

        1. 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.
        2. Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-706 [Up to Approximately 2 Years]
          Maximum observed serum/plasma concentration of ABBV-706.
        3. Time to Cmax (Tmax) of ABBV-706 [Up to Approximately 2 Years]
          Time to Cmax of ABBV-706.
        4. 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.
        5. 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.
        6. Antidrug Antibodies (ADAs) [Up to Approximately 2 Years]
          Incidence and concentration of anti-drug antibodies.
        7. Neutralizing Antibodies (nAbs) [Up to Approximately 2 Years]
          Incidence and concentration of neutralizing antibodies.
        8. 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.
        9. 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.
        10. 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.
        11. 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.
        12. 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).
        13. 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.
        14. 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 /ID# 259884 | Duarte, California, United States, 91010
        • Yale School of Medicine /ID# 246647 | New Haven, Connecticut, United States, 06519
        • Georgetown University Hospital /ID# 255352 | Washington, District of Columbia, United States, 20007
        • 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
        • 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 Universitario Vall d'Hebron /ID# 258659 | Barcelona, Spain, 08035
        • Hospital Universitario Ramon y Cajal /ID# 257291 | Madrid, Spain, 28034
        • 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

          More Information

          Additional Information

          Additional Relevant MeSH Terms

          • Neoplasms