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Monoclonal Antibodies

ABBV-303 Dose Escalation: Part 1B Combination 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

"This trial aims to test a new drug, ABBV-303, for the treatment of solid tumors. The study will assess the safety, effectiveness, and how the drug moves through the body when

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With Adverse Events (AE)

Secondary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,198 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,917 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study currently open?

"According to data on clinicaltrials.gov, this study is currently in the recruitment phase. The trial was initially posted on February 29th, 2024 and most recently updated on February 6th, 2024."

Answered by AI

What is the total number of individuals who are currently enrolled as participants in this medical study?

"Indeed, information from clinicaltrials.gov confirms that this trial is actively seeking participants. Originally shared on February 29th, 2024, the most recent update was made on February 6th, 2024. The study aims to recruit 181 patients from a single site."

Answered by AI

Has the combination treatment involving ABBV-303 dose escalation in Part 1B been granted approval by the FDA?

"Given that this trial is categorized as Phase 1, the assessment of ABBV-303 Dose Escalation: Part 1B Combination safety by our team at Power stands at a score of 1. This is indicative of the limited available data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors

2024. "A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06158958.

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