What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those similar to ABBV-303 and Budigalimab, include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Additionally, investigational drugs like ABBV-303 may cause fatigue, nausea, and infusion-related reactions. Combining these treatments can potentially increase the frequency and severity of these side effects.

What prior FDA approvals exist?

Several PD-1 inhibitors and other immunotherapies have received FDA approval for the treatment of solid tumors. Pembrolizumab (Keytruda) and Nivolumab (Opdivo) are notable PD-1 inhibitors approved for various solid tumors, including non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC). Atezolizumab (Tecentriq), a PD-L1 inhibitor, is also approved for similar indications. These drugs work by blocking the PD-1/PD-L1 pathway, thereby enhancing the immune system's ability to fight cancer. The investigational drugs ABBV-303 and Budigalimab are being studied in a similar context, aiming to provide new therapeutic options for patients with advanced solid tumors.

What other types of research exist?

Promising alternatives to ABBV-303 and Budigalimab for solid tumors include: 1) Pembrolizumab (Keytruda) - a PD-1 inhibitor with extensive data supporting its efficacy in various solid tumors. 2) Nivolumab (Opdivo) - another PD-1 inhibitor with proven benefits in multiple cancer types. 3) Atezolizumab (Tecentriq) - a PD-L1 inhibitor used in combination with other therapies for enhanced efficacy. 4) Combination therapies involving immune checkpoint inhibitors and targeted therapies, such as Atezolizumab plus Bevacizumab or Pembrolizumab plus Lenvatinib. These alternatives have shown promising results in clinical trials and may offer effective treatment options for solid tumor patients in 2024.

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Monoclonal Antibodies

ABBV-303 + Budigalimab for Solid Tumors

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Participants with a diagnosis of a malignant solid tumor by histology (World Health Organization [WHO] criteria)

Must not have

Body weight < 35 kg

Unresolved Grade > 1 AEs from prior anti-cancer therapy except for alopecia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Summary

This trial is testing a new drug, ABBV-303, alone or with another drug, budigalimab, to treat adults with certain types of cancer that have returned or resisted other treatments. The drugs are given through an IV and aim to target and destroy cancer cells, possibly boosting the immune system's response.

Who is the study for?

This trial is for adults with advanced solid tumors that have not responded to previous treatments. Participants must be in good physical condition (ECOG status of 0 or 1), have certain laboratory values within normal ranges, and their tumor size can be measured by standard criteria.

What is being tested?

The study tests ABBV-303 alone and combined with Budigalimab in patients with relapsed/refractory solid tumors. It explores the safety, how the body processes these drugs, and their effect on cancer over a period of up to three years.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, changes in blood test results indicating organ function issues, fatigue, nausea, and other symptoms typically associated with cancer therapies.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I have been diagnosed with a solid tumor cancer.

Exclusion Criteria

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

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My body weight is less than 35 kg.

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I don't have lasting side effects from cancer treatment, except for hair loss.

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I do not have any active infections needing antibiotics or antifungal treatment.

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I am allergic to ingredients in ABBV-303 or budigalimab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants With Adverse Events (AE)

Secondary study objectives

Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1

ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST)

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

+2 more

Trial Design

7Treatment groups

Experimental Treatment

Group I: ABBV-303 Dose Expansion: Part 5A MonotherapyExperimental Treatment1 Intervention

Tissue agnostic with R/R participants with MET amplification by any commercially available test will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.

Group II: ABBV-303 Dose Expansion: Part 4A MonotherapyExperimental Treatment1 Intervention

Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.

Group III: ABBV-303 Dose Expansion: Part 3A MonotherapyExperimental Treatment1 Intervention

Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.

Group IV: ABBV-303 Dose Expansion: Part 2B CombinationExperimental Treatment2 Interventions

Participants with R/R NSCLC will receive ABBV-303 at or below the MTD in combination with budigalimab as part of the 3 year study duration.

Group V: ABBV-303 Dose Expansion: Part 2A MonotherapyExperimental Treatment1 Intervention

Participants with R/R NSCLC will receive ABBV-303 at the recommended phase 1 expansion dose (RP1ED) as a monotherapy as part of the 3 year study duration.

Group VI: ABBV-303 Dose Escalation: Part 1B CombinationExperimental Treatment2 Interventions

Participants with R/R solid tumors will receive ABBV-303 in combination with budigalimab at or below the MTD as part of the 3 year study duration.

Group VII: ABBV-303 Dose Escalation: Part 1A MonotherapyExperimental Treatment1 Intervention

Participants with (R)/refractory (R) solid tumors will receive ABBV-303 in escalating doses as a monotherapy until the maximum tolerable dose (MTD) is determined as part of the 3 year study duration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Budigalimab

2021

Completed Phase 1

~170

0 / 6Eligibility 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

Common treatments for solid tumors include immunotherapies and targeted therapies. Immunotherapies, such as PD-1 inhibitors like Budigalimab, block the PD-1 pathway, enabling the immune system to better recognize and attack cancer cells. Targeted therapies, potentially represented by ABBV-303, interfere with specific molecules involved in tumor growth and survival, inhibiting cancer cell proliferation. These mechanisms are important for solid tumor patients as they offer targeted approaches to control tumor growth and improve survival outcomes.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Cancer immunology and melanoma immunotherapy.Rituximab: an insider's historical perspective.

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Who is running the clinical trial?

AbbVieLead Sponsor

1,004 Previous Clinical Trials

513,586 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

430 Previous Clinical Trials

155,906 Total Patients Enrolled

~128 spots leftby Jan 2028

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