ABBV-303 + Budigalimab for Solid Tumors

No longer recruiting at 22 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Infections, Hypersensitivity, Low body weight, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ABBV-303, to determine its safety and effectiveness in treating various solid tumors. Participants will receive either ABBV-303 alone or in combination with another investigational drug, budigalimab. The study aims to identify the optimal dose and understand how the drugs interact. Ideal candidates for this trial are individuals whose previous cancer treatments were ineffective for their specific tumor type, such as relapsed lung or kidney cancer. Participants should be ready for regular hospital visits and frequent health checks throughout the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, ABBV-303 was generally safe in animal tests, with no major safety issues observed with repeated administration. Researchers are still studying this drug to determine its safety and effectiveness in humans. Past research showed that budigalimab alone was well-tolerated by patients with certain cancers. Since this trial is just beginning, safety information for both treatments in humans remains limited. However, early-stage trials like this one primarily focus on ensuring the treatments are safe for further testing, so researchers will closely monitor any serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-303 and budigalimab because they offer a novel approach to treating solid tumors. ABBV-303 targets specific cancer cell pathways that are often not addressed by standard chemotherapy or immunotherapy, potentially improving outcomes for patients with resistant or refractory tumors. Budigalimab, when used in combination, enhances the body's immune response against cancer cells, offering a synergistic effect that could outperform current treatments. This combination is particularly promising for hard-to-treat cancers like non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and head and neck squamous cell carcinoma (HNSCC), where traditional options are limited.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research shows that ABBV-303 targets a protein called c-Met, which often aids cancer cell growth and spread. By blocking this protein, ABBV-303 may help stop cancer progression. Early results suggest it could be effective in treating hard-to-treat solid tumors. In this trial, some participants will receive ABBV-303 as a monotherapy, while others will receive it with budigalimab, a drug that helps the immune system fight cancer. Initial data indicates that this combination may work even better. Although still in early testing, this combination aims to attack tumors more aggressively. The goal is to offer a new option for people whose cancers haven't responded to other treatments. ^{1 4 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug

Your recent lab test results need to meet the study's requirements before you can take the study drug.

I am fully active or can carry out light work.

Exclusion Criteria

My body weight is less than 35 kg.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABBV-303 as monotherapy or in combination with budigalimab in escalating doses to determine the maximum tolerable dose or recommended phase 1 expansion dose

Up to 3 years

Regular visits at a hospital or clinic for medical assessments, blood tests, and scans

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-303
• Budigalimab

Trial Overview 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.

How Is the Trial Designed?

Group I: ABBV-303 Dose Expansion: Part 5A Monotherapy Experimental Treatment 1 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 Monotherapy Experimental Treatment 1 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 Monotherapy Experimental Treatment 1 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 Combination Experimental Treatment 2 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 Monotherapy Experimental Treatment 1 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 Combination Experimental Treatment 2 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 Monotherapy Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Budigalimab, a monoclonal antibody targeting PD-1, demonstrated a safety profile similar to other PD-1 inhibitors, with the most common severe side effect being anemia in 22% of HNSCC patients and 13% of NSCLC patients.

In terms of efficacy, budigalimab showed objective response rates of 13% in head and neck squamous cell carcinoma (HNSCC) and 19% in non-small cell lung cancer (NSCLC), with median progression-free survival of 3.6 months and 1.9 months, respectively, indicating it may be a viable treatment option for these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma. Italiano, A., Cassier, PA., Lin, CC., et al.[2023]

A 68-year-old patient with stage IV lung adenocarcinoma showed an unexpected positive response to paclitaxel after failing treatment with pembrolizumab, an anti-PD-1 immunotherapy.

The patient experienced a response duration of over fourteen months with paclitaxel, suggesting that combining or sequencing chemotherapy with immunotherapy may enhance treatment effectiveness in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. Zapata, E., Mennecier, B., Leduc, C., et al.[2017]

The KEYNOTE-826 trial demonstrated that adding the PD-1 inhibitor pembrolizumab to standard chemotherapy significantly improves progression-free survival and overall survival in patients with advanced cervical cancer.

These results suggest that pembrolizumab could become the new standard treatment for patients with metastatic, recurrent, or persistent cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab May Substantially Up Cervical Cancer Survival. [2022]

In the JAVELIN Lung 100 trial involving 1214 patients with advanced NSCLC, avelumab showed longer median progression-free survival (PFS) compared to platinum-based chemotherapy (8.4 months vs. 5.6 months), indicating its potential efficacy as a first-line treatment.

Although avelumab demonstrated longer median overall survival (OS) compared to chemotherapy (20.1 months vs. 14.9 months), the differences were not statistically significant, suggesting that while avelumab may be beneficial, it did not meet the primary objective of the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC: Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial. Reck, M., Barlesi, F., Yang, JC., et al.[2023]

Cadonilimab, a bispecific PD-1/CTLA-4 antibody, demonstrated a manageable safety profile with 28% of patients experiencing grade 3-4 treatment-related adverse events, indicating it can be safely administered to patients with advanced solid tumors.

In a phase 2 trial, cadonilimab showed promising antitumor activity, with an objective response rate of 32.3% in cervical cancer patients, suggesting its potential effectiveness in treating advanced solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and antitumour activity of cadonilimab, an anti-PD-1/CTLA-4 bispecific antibody, for patients with advanced solid tumours (COMPASSION-03): a multicentre, open-label, phase 1b/2 trial. Gao, X., Xu, N., Li, Z., et al.[2023]

Cadonilimab is a bi-specific antibody targeting PD-1 and CTLA-4, developed for treating various solid tumors, and was approved in China in June 2022 specifically for patients with relapsed or metastatic cervical cancer who have not responded to platinum-based chemotherapy.

The approval of cadonilimab marks a significant milestone in cancer treatment, providing a new therapeutic option for patients with advanced cervical cancer after standard chemotherapy has failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cadonilimab: First Approval. Keam, SJ.[2022]

Budigalimab, a monoclonal antibody targeting the PD-1 receptor, demonstrated a manageable safety profile in a phase I trial with 59 patients, showing only 18.6% experiencing immune-related adverse events, and no grade 5 adverse events reported.

The drug achieved over 99% PD-1 receptor saturation within 2 hours of dosing, indicating effective pharmacodynamics, and showed comparable pharmacokinetics and safety profiles between Japanese and Western patients, supporting its potential as a viable treatment for advanced solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Model Informed Dosing Regimen and Phase I Results of the Anti-PD-1 Antibody Budigalimab (ABBV-181). Powderly, J., Spira, A., Kondo, S., et al.[2021]

The combination of MEDI0680 and durvalumab was found to be safe and tolerable in patients with advanced clear-cell renal cell carcinoma, but it did not show improved efficacy compared to nivolumab alone, with objective response rates of 16.7% for the combination and 23.8% for nivolumab.

Both treatment groups had a median progression-free survival of 3.6 months, and a notable percentage of patients (23.8% in the combination group) discontinued treatment due to adverse events, highlighting the need for careful monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. Voss, MH., Azad, AA., Hansen, AR., et al.[2023]

The immune checkpoint inhibitor COM701, which targets the PVRIG protein, has demonstrated early signs of effectiveness in treating advanced solid tumors in an ongoing phase I trial.

COM701 shows potential for enhanced efficacy when used in combination with nivolumab, suggesting a promising approach for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COM701 Shows Antitumor Activity, +/- Nivolumab. [2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06158958

NCT06158958 | A Study to Assess the Safety, ... The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with ...

2. news.abbvie.com news.abbvie.com/2025-05-27-AbbVie-Features-New-Data-Across-Difficult-to-Treat-Solid-Tumors-and-Blood-Cancers-at-ASCO-2025,-Highlighting-Breadth-and-Depth-of-its-Oncology-Portfolio

AbbVie Features New Data Across Difficult-to-Treat Solid ... These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers.

3. abbviescience.com abbviescience.com/en/pipeline/solid-tumors.html

SOLID TUMORS ABBV-303 is an investigational drug under clinical development. Safety and efficacy have not been established. ABBV-303 is a c-Met targeted TriNKET natural ...

4. kidneycancer.org kidneycancer.org/trial/a-study-of-adverse-events-how-intravenously-iv-infused-abbv-303-moves-through-the-body-and-change-in-disease-state-as-monotherapy-and-in-combination-with-iv-infused-budigalimab-abbv-181-in-adu/

A Study to Assess the Safety, Pharmacokinetics, and ... The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with ...

5. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-0336.html

A phase 1 first-in-human, open-label study evaluating the ... The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/441436

A Study to Assess the Safety, Pharmacokinetics, and ... ABBV-303 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study.

7. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M24-122

M24-122 The purpose of this study is to assess safety ... In Part B, ABBV-303 in combination with budigalimab will be IV infused in participants with R/R solid tumors or ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8783908/

First-in-human phase 1 study of budigalimab, an anti-PD-1 ... We present the safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data from patients enrolled in the head and neck squamous cell carcinoma (HNSCC) and ...