520 Participants Needed

ABBV-400 for Advanced Solid Cancers

Recruiting at 134 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 tests a new drug called ABBV-400 for adults with advanced cancers. The study aims to find the best dose and see how well it works, both alone and with other treatments. Patients will receive the drug through an IV and be closely monitored for effects and side effects.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, since the trial involves investigational drugs, it's possible that some medications might need to be adjusted. Please discuss with the trial team for specific guidance.

What safety data is available for ABBV-400 in treating advanced solid cancers?

The provided research does not contain specific safety data for ABBV-400, Telisotuzumab adizutecan, or its other names. The studies focus on immune checkpoint inhibitors like PD-1 and CTLA-4 inhibitors, which are different treatments. Therefore, no relevant safety data for ABBV-400 is available in the given research.12345

Is the drug ABBV-400 a promising treatment for advanced solid cancers?

ABBV-400, also known as Telisotuzumab adizutecan, is a promising drug for advanced solid cancers because it is a monoclonal antibody. Monoclonal antibodies have been shown to be effective in treating solid tumors by targeting specific growth factors or receptors on cancer cells, which can help stop the growth of tumors.678910

What data supports the idea that ABBV-400 for Advanced Solid Cancers is an effective treatment?

The available research does not provide specific data on the effectiveness of ABBV-400 for Advanced Solid Cancers. Instead, it discusses other treatments and therapies for solid tumors, such as monoclonal antibodies and immune checkpoint inhibitors, which have shown promise in treating various cancers. Without direct data on ABBV-400, we cannot conclude its effectiveness compared to these other treatments.1112131415

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, including non-small cell lung cancer (NSCLC) with or without EGFR mutations, gastroesophageal adenocarcinoma, and colorectal cancer that have progressed after prior treatments. Participants must be in good physical condition (ECOG 0 or 1), have measurable disease, meet specific lab criteria, and not be candidates for surgery or other beneficial therapies.

Inclusion Criteria

My advanced stomach or esophagus cancer has worsened after certain treatments.
I am fully active or can carry out light work.
My advanced colorectal cancer does not have the BRAF V600E mutation and has worsened despite treatment.
See 8 more

Exclusion Criteria

I have a history of lung conditions as specified in the study details.
I have not been treated with TAS-102 or regorafenib.
I have never needed steroids for lung inflammation nor show signs of it on a chest CT.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ABBV-400 monotherapy to determine the best dose

Varies
Regular visits at approved institutions

Dose Expansion

Participants receive ABBV-400 monotherapy or in combination with bevacizumab to confirm the dose

Varies
Regular visits at approved institutions

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • ABBV-400
Trial Overview The study tests ABBV-400's safety and effect on tumor activity in patients with various advanced cancers. It involves a dose escalation phase to find the best dose followed by an expansion phase to confirm it. Patients will receive different doses of ABBV-400 intravenously at multiple global sites.
How Is the Trial Designed?
12Treatment groups
Experimental Treatment
Group I: Part 7biii (Combination Comparator)Experimental Treatment2 Interventions
Group II: Part 7bii (Combination Dose Optimization High Dose)Experimental Treatment2 Interventions
Group III: Part 7bi (Combination Dose Optimization Low Dose)Experimental Treatment2 Interventions
Group IV: Part 7a (Combination Dose Escalation)Experimental Treatment2 Interventions
Group V: Part 6 (MET Mutation)Experimental Treatment1 Intervention
Group VI: Part 5 (MET Amplification)Experimental Treatment1 Intervention
Group VII: Part 4 (Colorectal Cancer)Experimental Treatment1 Intervention
Group VIII: Part 3 (Gastroesophageal Adenocarcinoma/Gastroesophagel JunctExperimental Treatment1 Intervention
Group IX: Part 2iii (Squamous NSCLC)Experimental Treatment1 Intervention
Group X: Part 2ii (mutEGFR NSCLC)Experimental Treatment1 Intervention
Group XI: Part 2i (wtEGFR Non-Small Cell Lung Cancer [NSCLC])Experimental Treatment1 Intervention
Group XII: Part 1 (Monotherapy Dose Escalation)Experimental 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 phase I trial of MEDI5752, a bispecific antibody that targets both PD-1 and CTLA4, shows that the drug is well tolerated by patients.
Preliminary results indicate that MEDI5752 is active in treating various tumor types, with durable responses observed, suggesting potential effectiveness in cancer therapy.
MEDI5752 Suppresses Two Immune Checkpoints.[2022]
In a phase II study involving 110 patients with advanced clear cell renal cell carcinoma (ccRCC), pembrolizumab demonstrated a 36.4% objective response rate, indicating significant antitumor activity as a first-line treatment.
The treatment was generally well-tolerated, with 30% of patients experiencing grade 3-5 adverse events, primarily colitis and diarrhea, which aligns with safety profiles observed in other cancers.
Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma.McDermott, DF., Lee, JL., Bjarnason, GA., et al.[2022]
Recent advances in antibody-based therapies, such as trastuzumab and bevacizumab, have shown promise in treating various solid tumors, including breast and colorectal cancers, with acceptable safety profiles.
Combining monoclonal antibodies with small-molecule inhibitors may enhance treatment efficacy and specificity, suggesting a potential direction for future cancer therapies.
Recent advances relating to the clinical application of naked monoclonal antibodies in solid tumors.Argyriou, AA., Kalofonos, HP.[2021]

Citations

MEDI5752 Suppresses Two Immune Checkpoints. [2022]
Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma. [2022]
Recent advances relating to the clinical application of naked monoclonal antibodies in solid tumors. [2021]
A phase I study of an agonist CD40 monoclonal antibody (CP-870,893) in combination with gemcitabine in patients with advanced pancreatic ductal adenocarcinoma. [2022]
DuoBody-CD40x4-1BB induces dendritic-cell maturation and enhances T-cell activation through conditional CD40 and 4-1BB agonist activity. [2022]
Targeting CTLA-4 in cancer: Is it the ideal companion for PD-1 blockade immunotherapy combinations? [2021]
Efficacy and safety of tislelizumab for malignant solid tumor: a systematic review and meta-analysis of phase III randomized trials. [2023]
Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors. [2023]
Real-world efficacy and toxicity of combined nivolumab and ipilimumab in patients with metastatic melanoma. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Dose dependence of treatment-related adverse events for immune checkpoint inhibitor therapies: a model-based meta-analysis. [2021]
Monoclonal antibodies as effective therapeutic agents for solid tumors. [2020]
XFab-α4-1BB/CD40L fusion protein activates dendritic cells, improves expansion of antigen-specific T cells, and exhibits antitumour efficacy in multiple solid tumour models. [2023]
Isatuximab plus atezolizumab in patients with advanced solid tumors: results from a phase I/II, open-label, multicenter study. [2022]
Drug evaluation: Volociximab, an angiogenesis-inhibiting chimeric monoclonal antibody. [2017]
15.United Statespubmed.ncbi.nlm.nih.gov
Dual-Targeting Approach for CD40 and 4-1BB. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security