ABBV-400 for Advanced Cancer

Recruiting at 66 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Chemotherapy, Immunotherapy, Biologics, others

Disqualifiers: Interstitial lung disease, Untreated brain metastases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 104 weeks

285 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ABBV-400 (Telisotuzumab adizutecan), a new drug for treating advanced solid tumors, which are cancers that have spread or can't be surgically removed. Researchers aim to observe patient responses to the drug and identify any side effects. Participants with specific cancers, such as pancreatic or breast cancer resistant to standard treatments, may qualify if they experience significant symptoms or challenges in managing their condition. The trial includes different groups, with some receiving the drug alone and others taking it with a medication that affects drug processing in the body. Regular check-ups will monitor the drug's effects and safety. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop any anticancer therapy, including chemotherapy, radiation, or immunotherapy, at least 28 days before starting ABBV-400. However, palliative radiation for certain conditions is allowed without a waiting period. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that ABBV-400 is likely to be safe for humans?

Research has shown that ABBV-400 has a safety profile manageable for patients with advanced solid tumors. In studies with pancreatic cancer patients, ABBV-400 was well-tolerated. Similarly, colorectal cancer studies found ABBV-400 safe and manageable, with doses of 2.4 mg/kg and 3.0 mg/kg showing promising results.

For head and neck cancer, early study results suggested a tolerable safety profile. Studies in patients with advanced esophageal cancer also demonstrated a tolerable safety profile. In trials with breast cancer patients, ABBV-400 was generally well-tolerated with manageable side effects.

When used with a CYP3A4 inhibitor (a drug that affects how other drugs are processed in the body), ABBV-400 maintained a manageable safety profile. This indicates that ABBV-400, whether used alone or with other treatments, has been found safe enough for further testing in clinical trials. However, as this is still in early testing, individual reactions may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-400 because it represents a novel approach to treating several types of advanced cancers. Unlike standard treatments such as chemotherapy and targeted therapies, ABBV-400 is an antibody-drug conjugate (ADC) designed to deliver a potent cytotoxic agent directly to the cancer cells, potentially sparing healthy cells and reducing side effects. This targeted mechanism allows ABBV-400 to hone in on specific proteins overexpressed in cancer cells, offering a more precise attack on tumors. With its potential to work where other treatments may fail, ABBV-400 could provide new hope for patients with difficult-to-treat cancers like pancreatic, biliary, and certain types of breast and head and neck cancers.

What evidence suggests that ABBV-400 could be an effective treatment for advanced solid tumors?

Research has shown that ABBV-400, also known as telisotuzumab adizutecan, holds promise in treating various advanced solid tumors. In this trial, participants with pancreatic cancer (Cohort 2) will receive ABBV-400. Studies found that 23.8% of these patients responded to the treatment, with benefits lasting about 6.9 months. Participants with biliary tract cancers (Cohort 3) will also receive ABBV-400, with previous research indicating a progression-free period of about 5.4 months. For those in the triple-negative breast cancer cohort (Cohort 5), research showed a 23.8% response rate when used as a second treatment option. Early results in hormone receptor-positive/HER2-negative breast cancer (Cohort 6) and head and neck cancer (Cohort 7) suggest that ABBV-400 is effective and well-tolerated. While more data is needed, these findings highlight ABBV-400's potential to slow disease progression and improve outcomes in difficult-to-treat cancers. ^{1 5 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with certain advanced solid tumors like liver, pancreatic, biliary tract cancers, esophageal squamous cell carcinoma, triple negative breast cancer, hormone receptor+/HER2- breast cancer or head and neck squamous-cell-carcinoma. Participants must have measurable disease activity and meet specific laboratory criteria without active lung issues or recent other cancer treatments.

Inclusion Criteria

I have an autoimmune or inflammatory condition affecting my lungs, or I've had a lung removed.

You have a measurable tumor according to specific guidelines.

You have the specific level of disease activity required for this study.

Exclusion Criteria

I have brain metastases but don't need steroids for swelling and have been stable for 2 weeks after treatment.

I have no active cancer other than what is allowed in the study.

I have no ongoing side effects from cancer treatment above mild, except for hair loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) ABBV-400 monotherapy for up to 2 years

Up to 104 weeks

Regular visits at approved institutions

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 104 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-400

Trial Overview

The trial is testing ABBV-400 as a monotherapy for up to two years in adults with various advanced solid tumors. Patients are grouped based on their type of cancer and will receive regular medical assessments including blood tests and questionnaires to monitor the treatment's effect.

How Is the Trial Designed?

Group I: Cohort 9: Drug-Drug Interaction Experimental Treatment 2 Interventions

Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Group II: Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer Experimental Treatment 1 Intervention

Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Group III: Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC) Experimental Treatment 1 Intervention

Participants with HNSCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Group IV: Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC) Experimental Treatment 1 Intervention

Participants with HR+/HER2-BC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Group V: Cohort 5: Triple Negative Breast Cancer (TNBC) Experimental Treatment 1 Intervention

Participants with TNBC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Group VI: Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC) Experimental Treatment 1 Intervention

Participants with ESCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Group VII: Cohort 3: Biliary Tract Cancers (BTC) Experimental Treatment 1 Intervention

Participants with BTC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Group VIII: Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC) Experimental Treatment 1 Intervention

Participants with PDAC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Group IX: Cohort 1: Hepatocellular Carcinoma (HCC) Experimental Treatment 1 Intervention

Participants with HCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

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

In a Phase I clinical trial involving 23 patients with advanced solid tumors, the intratumoral administration of the CD40 agonistic antibody ADC-1013 was found to be well tolerated, with most adverse events being mild and transient.

The treatment led to significant pharmacodynamic effects, including a marked decrease in peripheral blood B cell levels and increased activation of T cells, suggesting that ADC-1013 effectively activates the immune response against tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human study with intratumoral administration of a CD40 agonistic antibody, ADC-1013, in advanced solid malignancies. Irenaeus, SMM., Nielsen, D., Ellmark, P., et al.[2020]

ABBV-428, a tumor-targeted bispecific antibody, demonstrated an acceptable safety profile in a phase I study with 59 patients, showing no maximum tolerated dose reached and only mild infusion-related reactions reported.

Despite its safety, ABBV-428 showed minimal clinical activity in treating advanced mesothelioma and ovarian cancer, with only 36% of patients achieving stable disease, indicating that while the drug is safe, its effectiveness may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. Luke, JJ., Barlesi, F., Chung, K., et al.[2023]

DuoBody-CD40×4-1BB is a novel bispecific antibody that effectively enhances antitumor immunity by conditionally stimulating CD40 and 4-1BB, leading to improved dendritic cell maturation and T-cell activation in both laboratory assays and in patients with advanced solid tumors.

In a first-in-human clinical trial, DuoBody-CD40×4-1BB demonstrated significant immune modulation in patients, suggesting its potential as an effective treatment strategy for cancer when combined with PD-1 blocking antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DuoBody-CD40x4-1BB induces dendritic-cell maturation and enhances T-cell activation through conditional CD40 and 4-1BB agonist activity. Muik, A., Adams 3rd, HC., Gieseke, F., et al.[2022]

XFab-α4-1BB/CD40L is a bispecific antibody that effectively activates dendritic cells and promotes the proliferation of tumor-reactive T cells, leading to significant tumor regression in mouse models.

In non-human primates, XFab-α4-1BB/CD40L demonstrated a favorable safety profile with no liver toxicity observed at doses up to 51 mg/kg, indicating its potential for safe use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wang, B., Liu, Y., Yuan, R., et al.[2023]

The study developed bispecific antibodies that combine anti-CD40 and anti-41BB antibodies with a PDL1-specific blocking domain, allowing for effective immune stimulation without relying on FcγR binding, which can cause unwanted side effects.

These bispecific antibodies maintained their binding properties and effectively activated CD40 and 41BB signaling while also inhibiting PD1 activation, suggesting a promising strategy for enhancing the efficacy of cancer immunotherapy by linking checkpoint blockade with immune activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD40- and 41BB-specific antibody fusion proteins with PDL1 blockade-restricted agonism. Medler, J., Kucka, K., Melo, V., et al.[2022]

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New data from telisotuzumab adizutecan (Temab-A) and ABBV-706 across pancreatic, colorectal, and solid tumors, highlight progress in ...

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Telisotuzumab adizutecan showed meaningful improvements in overall response rate (ORR) for patients who received the drug at a dose of 2.4 mg/kg ...

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“ABBV-400 at both 2.4 mg/kg and 3.0 mg/kg [once every 3 weeks] showed promising antitumor activity in CRC, with a tolerable and manageable ...

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John H. Strickler, MD, discusses the efficacy and safety of telisotuzumab adizutecan in patients with MET gene–amplified gastric/GEJ cancer.