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

Study Purpose

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 350 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 3 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05599984
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Israel, Japan, Korea, Republic of, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumors
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 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.

Experimental: 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..

Experimental: Part 3a: ABBV-706 + Budigalimab

Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 1 year treatment period.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Interventions

Drug: - ABBV-706

Intravenous (IV) Infusion

Drug: - Cisplatin

Intravenous infusion

Drug: - Budigalimab

IV Infusion

Drug: - Carboplatin

Intravenous infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gilbert, Arizona

Status

Recruiting

Address

Banner MD Anderson Cancer Ctr /ID# 260129

Gilbert, Arizona, 85234

City of Hope /ID# 259884, Duarte, California

Status

Recruiting

Address

City of Hope /ID# 259884

Duarte, California, 91010

Yale School of Medicine /ID# 246647, New Haven, Connecticut

Status

Recruiting

Address

Yale School of Medicine /ID# 246647

New Haven, Connecticut, 06519

Washington, District of Columbia

Status

Recruiting

Address

Georgetown University Hospital /ID# 255352

Washington, District of Columbia, 20007

Fort Wayne, Indiana

Status

Recruiting

Address

Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130

Fort Wayne, Indiana, 46804

Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Hospitals and Clinics /ID# 246638

Iowa City, Iowa, 52242

Detroit, Michigan

Status

Recruiting

Address

Barbara Ann Karmanos Cancer In /ID# 261799

Detroit, Michigan, 48201

Henry Ford Hospital /ID# 246648, Detroit, Michigan

Status

Recruiting

Address

Henry Ford Hospital /ID# 246648

Detroit, Michigan, 48202

START Midwest /ID# 251257, Grand Rapids, Michigan

Status

Recruiting

Address

START Midwest /ID# 251257

Grand Rapids, Michigan, 49546-7062

Saint Louis, Missouri

Status

Recruiting

Address

Washington University-School of Medicine /ID# 246286

Saint Louis, Missouri, 63110

New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303

New York, New York, 10065-6007

Duke Cancer Center /ID# 246285, Durham, North Carolina

Status

Recruiting

Address

Duke Cancer Center /ID# 246285

Durham, North Carolina, 27710

UH Cleveland Medical Center /ID# 246641, Cleveland, Ohio

Status

Recruiting

Address

UH Cleveland Medical Center /ID# 246641

Cleveland, Ohio, 44106

Univ Oklahoma HSC /ID# 250884, Oklahoma City, Oklahoma

Status

Recruiting

Address

Univ Oklahoma HSC /ID# 250884

Oklahoma City, Oklahoma, 73117

Tennessee Oncology, PLLC /ID# 246283, Nashville, Tennessee

Status

Recruiting

Address

Tennessee Oncology, PLLC /ID# 246283

Nashville, Tennessee, 37203

Houston, Texas

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center /ID# 246287

Houston, Texas, 77030

San Antonio, Texas

Status

Recruiting

Address

South Texas Accelerated Research Therapeutics /ID# 248946

San Antonio, Texas, 78229

University of Utah /ID# 246640, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah /ID# 246640

Salt Lake City, Utah, 84112-5500

Tacoma, Washington

Status

Recruiting

Address

Northwest Medical Specialties - Tacoma /ID# 262801

Tacoma, Washington, 98405

International Sites

Heidelberg, Victoria, Australia

Status

Recruiting

Address

Austin Health and Ludwig Institute for Cancer Research /ID# 255174

Heidelberg, Victoria, 3084

Peter MacCallum Cancer Ctr /ID# 259197, Melbourne, Victoria, Australia

Status

Recruiting

Address

Peter MacCallum Cancer Ctr /ID# 259197

Melbourne, Victoria, 3000

Rambam Health Care Campus /ID# 255059, Haifa, H_efa, Israel

Status

Recruiting

Address

Rambam Health Care Campus /ID# 255059

Haifa, H_efa, 3109601

Ramat Gan, Tel-Aviv, Israel

Status

Recruiting

Address

The Chaim Sheba Medical Center /ID# 254915

Ramat Gan, Tel-Aviv, 5265601

Jerusalem, Israel

Status

Recruiting

Address

Hadassah Medical Center-Hebrew University /ID# 255147

Jerusalem, , 91120

Kashiwa-shi, Chiba, Japan

Status

Recruiting

Address

National Cancer Center Hospital East /ID# 259417

Kashiwa-shi, Chiba, 277-8577

Matsuyama-shi, Ehime, Japan

Status

Recruiting

Address

National Hospital Organization Shikoku Cancer Center /ID# 261279

Matsuyama-shi, Ehime, 791-0280

Hokkaido Cancer Center /ID# 261278, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

Hokkaido Cancer Center /ID# 261278

Sapporo-shi, Hokkaido, 003-0804

Kyoto University Hospital /ID# 259419, Kyoto-shi, Kyoto, Japan

Status

Recruiting

Address

Kyoto University Hospital /ID# 259419

Kyoto-shi, Kyoto, 606-8507

Shizuoka Cancer Center /ID# 261277, Sunto-gun, Shizuoka, Japan

Status

Recruiting

Address

Shizuoka Cancer Center /ID# 261277

Sunto-gun, Shizuoka, 411-8777

Koto, Tokyo, Japan

Status

Recruiting

Address

The Cancer Institute Hospital Of JFCR /ID# 260132

Koto, Tokyo, 135-8550

Wakayama-shi, Wakayama, Japan

Status

Recruiting

Address

Wakayama Medical University Hospital /ID# 260131

Wakayama-shi, Wakayama, 641-8510

National Cancer Center /ID# 248938, Goyang-si, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

National Cancer Center /ID# 248938

Goyang-si, Gyeonggido, 10408

CHA Bundang Medical Center /ID# 248939, Seongnam, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

CHA Bundang Medical Center /ID# 248939

Seongnam, Gyeonggido, 13496

Hwasun-gun, Jeonranamdo, Korea, Republic of

Status

Recruiting

Address

Chonnam National University Hwasun Hospital /ID# 248943

Hwasun-gun, Jeonranamdo, 58128

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

Yonsei University Health System Severance Hospital /ID# 248937

Seoul, Seoul Teugbyeolsi, 03722

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital /ID# 248940

Seoul, , 03080

Samsung Medical Center /ID# 248936, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center /ID# 248936

Seoul, , 06351

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramon y Cajal /ID# 257291

Madrid, , 28034

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario HM Sanchinarro /ID# 258657

Madrid, , 28050

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