What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy agents such as etoposide and platinum compounds (cisplatin or carboplatin), which can cause side effects like nausea, vomiting, hair loss, fatigue, and increased risk of infection due to lowered blood cell counts. Immunotherapy agents, such as PD-1 inhibitors (e.g., nivolumab, pembrolizumab), can lead to immune-related side effects including fatigue, rash, diarrhea, and inflammation of organs like the lungs (pneumonitis) and liver (hepatitis). Specific to the ABBV-011 trial, ABBV-011 (an antibody-drug conjugate) and budigalimab (a PD-1 inhibitor) may have similar side effects, with ABBV-011 potentially causing additional infusion-related reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC), including immune checkpoint inhibitors and chemotherapy agents. Notably, nivolumab (Opdivo) and pembrolizumab (Keytruda), both anti-PD-1 antibodies, have been approved for SCLC, particularly in the relapsed or refractory settings. These drugs are similar to budigalimab, which is also an anti-PD-1 antibody. Additionally, traditional chemotherapy agents like etoposide and platinum-based drugs (cisplatin or carboplatin) are commonly used in combination regimens for SCLC. While specific antibody-drug conjugates like ABBV-011 have not been highlighted in the provided context, the combination of immune checkpoint inhibitors with other therapeutic agents represents a promising area of ongoing research and treatment development.

What other types of research exist?

Promising, novel alternatives to ABBV-011 for Small Cell Lung Cancer patients include: 1) Amrubicin, which is currently permitted in Japan for relapsed SCLC and has shown variable efficacy and safety in studies. 2) Anlotinib combined with PD-1 blockade, which has demonstrated efficacy and safety in a real-world retrospective study in China. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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Monoclonal Antibodies

ABBV-011 + Budigalimab for Small Cell Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed small cell lung cancer (SCLC) that is relapsed or refractory following at least 1 prior platinum-containing 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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years after the first participant receives first dose of study drug

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, ABBV-011, alone and with budigalimab, in patients whose small cell lung cancer has returned or didn't respond to treatment. ABBV-011 aims to kill cancer cells directly, and budigalimab boosts the immune system to fight the cancer.

Who is the study for?

This trial is for adults with small cell lung cancer that's come back or hasn't responded to treatment. They should have had no more than three prior therapies and can't be eligible for curative treatments. Participants need a certain level of health, including organ function, and an expected lifespan of at least 12 weeks. They must not have serious heart conditions, liver issues like cirrhosis, or a history of severe drug reactions.

What is being tested?

The study tests ABBV-011 alone and combined with Budigalimab in people whose lung cancer has relapsed or is resistant to treatment. It includes dose-finding and expansion phases for both the single agent (ABBV-011) and the combination therapy with Budigalimab.

What are the potential side effects?

Potential side effects may include typical reactions to immunotherapy such as fatigue, allergic responses to ingredients in the drugs, liver problems, neurological symptoms due to inflammation caused by immune response, digestive disturbances from off-target effects on healthy cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My small cell lung cancer has returned or didn't respond after 1-3 treatments with platinum-based chemotherapy, and there's no cure available.

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I have a tumor or lymph node large enough to be measured on a CT scan.

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I am fully active or can carry out light work.

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My tumor tests positive for the specific target needed for Parts B and C of the study.

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My SCLC tumor is SEZ6 positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of liver issues or alcohol dependence.

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I have had a stem cell transplant before.

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I have a history of heart rhythm problems.

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I currently have COVID-19.

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I have a history of inflammatory bowel disease.

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I do not have severe nerve pain or damage.

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My body weight is under 35 kilograms.

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I do not have active lung inflammation or a history of it that needed steroid treatment.

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I have not received a live vaccine in the last 30 days.

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I have never had a primary immunodeficiency, organ transplant, or tuberculosis.

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I do not have a history of or current interstitial lung disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years after the first participant receives first dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years after the first participant receives first dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years after the first participant receives first dose of study drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Laboratory Abnormaities

Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011

Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in Combination with Budigalimab

+4 more

Secondary study objectives

Accumulation Ratio of ABBV-011

Apparent Terminal Half-Life (T1/2) of ABBV-011

Area Under the Serum Concentration-Time Curve (AUCinf) of ABBV-011

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part D: ABBV-011 Dose Evaluation for JapanExperimental Treatment1 Intervention

ABBV-011 via intravenous administration will be administered every 3 weeks (Q3wk), on Day 1 of each 21-day cycle or alternate dosing regimens.

Group II: Part C: ABBV-011 + Budigalimab Escalation and ExpansionExperimental Treatment2 Interventions

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.

Group III: Part B: ABBV-011 Dose ExpansionExperimental Treatment1 Intervention

ABBV-011 via intravenous administration at dose regimen(s) that will not exceed the maximum tolerated dose determined in Part A.

Group IV: Part A: ABBV-011 Dose EscalationExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-011

2018

Completed Phase 1

~140

Budigalimab

2021

Completed Phase 1

~170

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy agents like etoposide and platinum compounds (cisplatin or carboplatin) work by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Immunotherapy, such as anti-PD-1 or anti-PD-L1 antibodies (e.g., Budigalimab), enhances the immune system's ability to recognize and destroy cancer cells by blocking the proteins that inhibit immune response. Targeted therapies, like ABBV-011, are designed to specifically target and kill cancer cells with minimal damage to normal cells. These mechanisms are crucial for SCLC patients because SCLC is an aggressive cancer with a high rate of proliferation and early metastasis, making it highly responsive to treatments that can rapidly reduce tumor burden and enhance immune surveillance.