ABBV-CLS-579 for Cancer

No longer recruiting at 20 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must be taking: PD-1/PD-L1 therapy

Must not be taking: Steroids, Immunostimulatory agents

Disqualifiers: Brain metastases, Hepatitis, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called ABBV-CLS-579 for individuals with certain types of tumors. The goal is to assess its safety and effectiveness when used alone or with other cancer treatments. The study divides into different parts to identify the best dose of the drug, either on its own or with other medicines. Individuals with solid tumors unresponsive to standard treatments and in advanced stages of cancer might be suitable candidates. Participants will undergo regular check-ups and tests to monitor the treatment's effects. 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 if you need to stop taking your current medications. However, if you are on anticoagulant therapy, your INR (a blood test that measures how long it takes blood to clot) must be within the therapeutic goal. It's best to discuss your specific medications with the trial team.

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

Research shows that ABBV-CLS-579 remains in the early testing stages, so detailed safety information is not yet available. This phase of the study focuses on assessing the treatment's safety. Researchers will closely monitor participants for any side effects as they receive the drug.

ABBV-CLS-579 is being tested both alone and in combination with other treatments, including a PD-1 inhibitor and a VEGFR TKI, which are types of cancer treatments. Although specific safety data for ABBV-CLS-579 is not yet available, studies have generally found PD-1 inhibitors and VEGFR TKIs to be well-tolerated.

Participants in this study will undergo close monitoring to help doctors understand reactions to the treatment. Regular check-ups and tests will ensure participant safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-CLS-579 because it offers a fresh approach to tackling cancer. Unlike standard treatments, which often target cancer cells broadly, ABBV-CLS-579 works by inhibiting specific pathways like the Vascular Endothelial Growth Factor Receptor (VEGFR) and Programmed Cell Death-1 (PD-1), which are crucial for tumor growth and immune evasion. This dual mechanism has the potential to improve effectiveness and minimize side effects, offering new hope for patients with tough-to-treat cancers like advanced renal cell carcinoma and head and neck squamous cell carcinoma. By combining with existing therapies, it may also boost the body's immune response to cancer cells more effectively.

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

Research has shown that ABBV-CLS-579 is being tested in this trial to determine its effectiveness in treating tumors by blocking proteins that aid cancer growth. Participants may receive ABBV-CLS-579 alone, with early results suggesting it might slow tumor growth in some cases. In other trial arms, ABBV-CLS-579 is combined with a PD-1 inhibitor, which enhances the immune system's ability to fight cancer, potentially boosting the immune response. Another combination being tested includes a VEGFR TKI, a drug that cuts off the blood supply to tumors, potentially increasing treatment effectiveness. These combinations aim to attack cancer from different angles, increasing the chances of shrinking tumors or stopping their growth. However, more data is still being collected to confirm its efficacy. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults with certain advanced solid tumors, including specific types of lung cancer (NSCLC), head and neck cancer (HNSCC), and kidney cancer (ccRCC) that have not responded to standard treatments or for which no effective treatment exists. Participants must have tried a PD-1/PD-L1 therapy before, weigh at least 35 kg, have an ECOG performance status ≤2, life expectancy ≥12 weeks, meet laboratory value criteria, and be able to swallow capsules.

Inclusion Criteria

Laboratory values meeting protocol criteria

I have had at least one treatment targeting PD-1/PD-L1 for my cancer type.

My advanced cancer has no standard treatment left, but I've had at least one cancer treatment before.

Exclusion Criteria

I have had cancer before, but it fits the exceptions.

I have a digestive issue that affects my ability to absorb pills or swallow capsules.

I have had bleeding issues, like coughing up blood or bloody stools.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Escalation

ABBV-CLS-579 is administered alone in escalating dose levels to eligible subjects with advanced solid tumors

Up to 44 days

Regular visits for assessments and monitoring

Combination Dose Escalation

ABBV-CLS-579 is administered in combination with a PD-1 targeting agent in escalating dose levels to eligible subjects with advanced solid tumors

Up to 64 days

Regular visits for assessments and monitoring

Combination Dose Expansion

ABBV-CLS-579 is administered at the recommended dose in combination with a PD-1 target agent or with a VEGFR TKI in subjects with specific advanced cancers

Up to 64 days

Regular visits for assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-CLS-579
• PD-1 inhibitor
• VEGFR TKI

Trial Overview The trial is testing ABBV-CLS-579 alone and in combination with a PD-1 inhibitor or VEGFR TKI on patients with advanced tumors. It's divided into three parts: dose escalation of ABBV-CLS-579 alone; dose escalation in combination with a PD-1 inhibitor; and expansion using the best dose found along with either a PD-1 inhibitor or VEGFR TKI for specific cancers.

How Is the Trial Designed?

Group I: Monotherapy Dose Escalation Experimental Treatment 1 Intervention

ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors

Group II: Combination Expansion with VEGFR TKI Experimental Treatment 2 Interventions

ABBV-CLS-579 will be administered at the determined recommended dose in combination with Vascular Endothelial Growth (VEGFR) Factor Receptor Tyrosine Kinase Inhibitor (TKI) in subjects with advanced ccRCC.

Group III: Combination Expansion with PD-1 Experimental Treatment 2 Interventions

ABBV-CLS-579 will be administered at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), microsatellite instability-high (MSI-H) tumors, and advanced clear cell renal cell carcinoma (ccRCC)

Group IV: Combination Dose Escalation with PD-1 Experimental Treatment 2 Interventions

ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors

Group V: Backfill Cohorts with Monotherapy Experimental Treatment 1 Intervention

ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors

Group VI: Backfill Cohorts in Combination with PD-1 Experimental Treatment 2 Interventions

ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors

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

Calico Life Sciences LLC

Industry Sponsor

Trials

11

Recruited

960+

Published Research Related to This Trial

A large-scale retrospective study of 2094 cases from the FDA adverse event reporting system found that combining immune checkpoint inhibitors with bevacizumab significantly increases the risk of adverse drug reactions (ADRs) in cancer patients, particularly interstitial lung disease, hypertension, and gastrointestinal bleeding.

The study highlights that combination therapy is an independent risk factor for these ADRs, suggesting the need for careful monitoring and individualized management strategies for patients undergoing this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions associated with immune checkpoint inhibitors and bevacizumab: A pharmacovigilance analysis. Gu, T., Jiang, A., Zhou, C., 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]

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]

A comparison of 551 patients from a healthcare claims database and 951 patients from a conventional post-marketing surveillance study showed that while patient characteristics and drug use were similar, there were significant differences in the reported adverse events (AEs) for eribulin mesylate, particularly for nausea and neutropenia.

The study suggests that healthcare claims databases can effectively complement traditional post-marketing surveillance in monitoring the safety profile of eribulin, but highlights the need for better definitions of AEs like neutropenia based on laboratory data to improve accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study. Sakata, Y., Matsuoka, T., Ohashi, S., et al.[2020]

Bamlanivimab (BAM) has a higher number of adverse event signals compared to bamlanivimab/etesevimab (BAM/ETE), with specific risks like atrial fibrillation and tachycardia associated with BAM but not BAM/ETE.

While BAM/ETE is generally considered safe, potential safety signals such as acute respiratory failure and infusion-related reactions have been identified and warrant long-term monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of adverse events of bamlanivimab, bamlanivimab/etesevimab used for COVID-19 based on FAERS database. Zhao, Y., Wang, H., Zhang, Q., et al.[2023]

In a study of 158 previously untreated CLL patients, the combination of obinutuzumab and bendamustine (G-B) showed an overall response rate of 81.0% and a 2-year progression-free survival rate of 81.8%, indicating strong clinical efficacy.

While G-B treatment had manageable toxicity, with 82.3% of patients experiencing grade ≥3 adverse events, careful monitoring for tumor lysis syndrome (TLS) was necessary due to its occurrence in 8.2% of patients, including two fatalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study. Stilgenbauer, S., Leblond, V., Foà, R., et al.[2023]

A large-scale analysis of 16,196 serious adverse drug reaction reports identified 36 potential safety signals associated with ibrutinib, including ischemic heart diseases and fractures, highlighting the need for careful patient monitoring.

The study found that over half of the reports resulted in hospitalization, indicating that while ibrutinib is a standard treatment for B-cell malignancies, its safety profile requires further investigation to confirm these findings in broader populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database. Allouchery, M., Tomowiak, C., Lombard, T., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04417465

NCT04417465 | First In Human Study With ABBV-CLS-579 ... The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone and in combination with a PD-1 target agent or with a VEGF TKI.

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M20-124

First In Human Study With ABBV-CLS-579 When Given ... The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone and in combination with a PD-1 target agent or with a VEGF TKI.

3. withpower.com withpower.com/trial/abbv-cls-579-for-cancer-ef227

ABBV-CLS-579 for Cancer · Info for Participants This trial tests the safety and effectiveness of ABBV-CLS-579, a new drug for treating tumors. It includes patients with advanced cancers that haven't ...

4. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04417465/

Clinical Trial: NCT04417465 The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone or in combination with programmed cell death protein- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10374545/

A small molecule inhibitor of PTP1B and PTPN2 enhances T ... At present two PTP1B/PTPN2 inhibitors, ABBV-CLS-484 (Fig. S1) and ABBV-CLS-579, are in phase I clinical trials (NCT04417465, NCT04777994) for patients with ...