192 Participants Needed

ABBV-303 + Budigalimab for Solid Tumors

Recruiting at 19 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AbbVie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

What is known about the safety of Budigalimab (ABBV-181) in humans?

In a phase I trial, Budigalimab was tested in patients with advanced solid tumors, and immune-related side effects were reported in about 18.6% of patients, with only 1.7% experiencing severe side effects. The safety profile was similar to other drugs targeting the same PD-1 receptor, and no treatment-related deaths were reported.12345

What makes the drug ABBV-303 + Budigalimab unique for treating solid tumors?

The combination of ABBV-303 and Budigalimab is unique because Budigalimab is a monoclonal antibody that targets the PD-1 receptor, which plays a role in the immune system's ability to fight cancer. This drug is administered intravenously and has shown a consistent safety profile similar to other PD-1 targeting agents, with a dosing regimen informed by pharmacokinetic modeling to optimize its effectiveness.13467

What data supports the effectiveness of the drug ABBV-303 + Budigalimab for solid tumors?

Budigalimab, a part of the treatment, has shown some effectiveness in early trials for advanced solid tumors, with a few patients responding to the drug. Its safety profile is similar to other drugs that target PD-1, a protein that helps keep the immune system from attacking cancer cells.12589

Who Is on the Research Team?

AI

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.
See 5 more

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 do not have any active infections needing antibiotics or antifungal treatment.
See 1 more

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?
7Treatment groups
Experimental Treatment
Group I: ABBV-303 Dose Expansion: Part 5A MonotherapyExperimental Treatment1 Intervention
Group II: ABBV-303 Dose Expansion: Part 4A MonotherapyExperimental Treatment1 Intervention
Group III: ABBV-303 Dose Expansion: Part 3A MonotherapyExperimental Treatment1 Intervention
Group IV: ABBV-303 Dose Expansion: Part 2B CombinationExperimental Treatment2 Interventions
Group V: ABBV-303 Dose Expansion: Part 2A MonotherapyExperimental Treatment1 Intervention
Group VI: ABBV-303 Dose Escalation: Part 1B CombinationExperimental Treatment2 Interventions
Group VII: ABBV-303 Dose Escalation: Part 1A MonotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

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.
COM701 Shows Antitumor Activity, +/- Nivolumab.[2021]
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.
Cadonilimab: First Approval.Keam, SJ.[2022]
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.
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]

Citations

COM701 Shows Antitumor Activity, +/- Nivolumab. [2021]
Cadonilimab: First Approval. [2022]
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. [2023]
Model Informed Dosing Regimen and Phase I Results of the Anti-PD-1 Antibody Budigalimab (ABBV-181). [2021]
Pembrolizumab May Substantially Up Cervical Cancer Survival. [2022]
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. [2023]
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. [2023]
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. [2023]
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]
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