[M17-327] A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer

JRCT ID: jRCT2051200161

Registered date:25/03/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or Refractory Small Cell Lung Cancer
• Date of first enrollment: 23/06/2021
• Target sample size: 188
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

Single-Agent ABBV-011
Part A: Dose Escalation
ABBV-011 via intravenous administration at various
doses and dosing regimens until the maximum
tolerated dose and/or the recommended Part B
dose(s) is declared.
Part B: Dose Expansion
ABBV-011 via intravenous administration at dose
regimen(s) that will not exceed the maximum tolerated dose determined in Part A.
Part D: Dose Escalation
ABBV-011 via intravenous administration will be administered every 3 weeks (Q3wk), on Day 1 of each 21-day cycle or alternate dosing regimens.

ABBV-011 and Budigalimab (ABBV-181) Combination
Part C: Escalation and Expansion
ABBV-011 via intravenous administration at various
doses and dosing regimens starting at least 1 dose
level below the recommended single-agent dose of
ABBV-011 for Part B plus Budigalimab via intravenous
administration at fixed doses and various dosing
regimens.

Outcome(s)

Primary Outcome

1. Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug]
2. Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011
The Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 will be determined during the Part A dose escalation cohort. [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug]
3. Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in Combination with Budigalimab
The Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in combination with budigalimab will be determined during the Part C dose escalation cohort. [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug]
4. Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs are adverse events as described in the protocol. [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug]
5. Mean Change from Baseline in Vital Signs
Mean change from Baseline in vital signs like blood pressure will be assessed. [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug]
6. Incidence of Laboratory Abnormalities
Number of participants with lab abnormalities will be assessed. [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug]
7. Mean Change from Baseline in Electrocardiogram (ECG) Parameters
Mean change from Baseline in ECG parameters like QTc interval will be assessed. [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug]

Key inclusion & exclusion criteria

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

Include criteria

- Must have histologically or cytologically confirmed small cell lung cancer (SCLC) that is relapsed or refractory following at least 1 prior platinum-based systemic chemotherapy, but no more than 3 total prior lines of therapy, and with no curative therapy available.
- Measurable disease, defined as at least 1 tumor lesion greater than or equal to 10 mm in the longest diameter or a lymph node greater than or equal to 15 mm in short axis measurement assessed by computed tomography (CT) scan, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Minimum life expectancy of at least 12 weeks.
- Recovery to at least Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.
- Adequate hematologic, hepatic, neurologic, and renal function.
- All participants in Part B and Part C will be required to have tumor tissue that tests positive for target expression.
- Sponsor may elect for confirmed SCLC tumor tissue to test positive for target expression for Parts A and D participants as well.
- Last dose of any prior anticancer therapy >= 4 weeks before the first dose of study drug.

Additional Inclusion Criteria for Study Part B and Part C:
- SCLC tumor tissue that tests positive for seizure-related homolog 6 (SEZ6) by immunohistochemistry (IHC).

Exclude criteria

- History of confirmed or suspected liver cirrhosis, hepatic veno-occlusive disease (VOD), sinusoidal obstruction syndrome (SOS), alcohol dependence, or ongoing excessive alcohol use.
- Prior history of allogeneic or autologous stem cell transplantation.
- Documented history of stroke or clinically significant cardiac disease as described in the protocol within 6 months prior to the first dose of study drug.
- History of cardiac conduction abnormalities as described in the protocol.
- Recent or ongoing serious infection, as described in the protocol.
- Active SARS-CoV-2 infection.
- Prior or concomitant malignancies with some exceptions, as described in the protocol.
- Any significant medical or psychiatric condition, including any suggested by Screening laboratory findings, that in the opinion of the Investigator or Sponsor may place the participant at undue risk from the study treatment, interfere with interpretation of study results, or compromise ability to comply with protocol requirements.

Additional Exclusion Criteria for Part C:
- History of inflammatory bowel disease.
- Peripheral neuropathy Grade 2 with pain, or Grade 3 or higher.
- Body weight less than 35 kilograms.
- Active pneumonitis or interstitial lung disease (ILD) or a history of pneumonitis/ILD requiring treatment with steroids.
- Participants previously treated with an anti PD-1/PD-L1 targeting agent must meet additional criteria described in the protocol.
- Participant is judged by the Investigator to have evidence of ongoing hemolysis.
- Immunosuppressive use with exceptions as per protocol.
- Participants who have received a live vaccine within 30 days of start of study treatment.
- Active autoimmune disease with exceptions as indicated in the protocol.
- History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
- Participants with a history of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS).

Additional exclusion criteria for Part D (Japanese participants):
- Participants with a history of hypersensitivity to the ingredients of ABBV-011 will be excluded.
- Participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).

Related Information

• Primary Sponsor: Yajima Yoko
• Secondary ID(s): NCT03639194