ABBV-637 + Chemotherapy for Cancer

Not currently recruiting at 57 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Congestive heart failure, Cardiac arrhythmia, 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 examines the safety and effectiveness of a new drug, ABBV-637, for treating solid tumors, specifically non-small cell lung cancer (NSCLC). Researchers are testing ABBV-637 alone and in combination with other cancer drugs, such as docetaxel (a chemotherapy drug) and osimertinib (a targeted therapy), to evaluate their efficacy and potential side effects. Suitable candidates for this trial have NSCLC that has recurred or not responded to other treatments, like chemotherapy or targeted therapy. Participants will undergo regular check-ups and tests to monitor treatment effects. 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 drug.

Will I have to stop taking my current medications?

The trial information does not specify if 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?

Research shows that ABBV-637 is promising and appears well-tolerated by individuals with solid tumors. Studies have demonstrated that ABBV-637, both alone and with other drugs like osimertinib or docetaxel, had expected and manageable side effects.

When combined with osimertinib, ABBV-637 performed well without causing major unexpected issues. Similarly, its combination with docetaxel yielded positive safety results.

ABBV-637 remains in early testing, focusing on safety assessment. So far, the results are encouraging, but further research is necessary to confirm these findings. Prospective trial participants should know that scientists are diligently working to ensure the treatment's safety before proceeding further. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-637 because it targets cancer cells differently than many standard treatments. Most traditional cancer therapies, like chemotherapy, attack rapidly dividing cells indiscriminately, but ABBV-637 is designed to target specific proteins on cancer cells, potentially reducing harm to normal cells. This can mean fewer side effects and a more efficient attack on the cancer itself. Combined with drugs like osimertinib and docetaxel, ABBV-637 might enhance the effectiveness of these existing treatments, offering a promising new approach for tackling tough-to-treat cancers.

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

Research has shown that the experimental drug ABBV-637 may help treat solid tumors. Early results suggest that 36% of patients experienced stable disease for more than 12 weeks with ABBV-637 treatment. In this trial, participants in different arms will receive ABBV-637 combined with other treatments. One arm will test ABBV-637 with osimertinib, a drug already used for some lung cancers, to determine if the combination improves outcomes compared to osimertinib alone. Another arm will test ABBV-637 with docetaxel, another chemotherapy drug, to evaluate their combined effectiveness. Although the results are still under investigation, these combinations are being studied for their potential to more effectively stop or slow cancer growth. ^{1 3 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with relapsed/refractory solid tumors, specifically non-small cell lung cancer (NSCLC), who have tried all standard treatments can join. They must be in good physical condition (ECOG 0 or 1) and meet specific lab values. For certain parts of the study, participants need to have a history of NSCLC that has worsened after specific previous treatments.

Inclusion Criteria

Your disease can be measured using specific guidelines for evaluating tumors.

I have been diagnosed with a solid tumor.

Your lab test results must meet the specific values outlined in the study's instructions.

Exclusion Criteria

I have side effects from cancer treatment that have not gone away, except for hair loss.

I have had serious heart issues in the last 6 months.

I have never needed steroids for lung inflammation nor do I currently have it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1: ABBV-637 Monotherapy

Participants receive escalating doses of ABBV-637 in 28-day cycles

28-day cycles

Regular visits at a hospital or clinic

Treatment - Part 2: ABBV-637 + Docetaxel

Participants receive ABBV-637 in combination with docetaxel in 28-day cycles

28-day cycles

Regular visits at a hospital or clinic

Treatment - Part 3: ABBV-637 + Osimertinib

Participants receive ABBV-637 in combination with osimertinib in 28-day cycles

28-day cycles

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 3 years

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-637
• Docetaxel
• Osimertinib

Trial Overview The trial is testing ABBV-637 alone or combined with Docetaxel/Osimertinib for safety and effectiveness against NSCLC. It's divided into three parts: first tests ABBV-637 solo, then its combination with Docetaxel, and finally with Osimertinib. Participants will receive cycles of treatment over approximately 28 days.

How Is the Trial Designed?

Group I: Part 3b: ABBV-637 + Osimertinib Experimental Treatment 2 Interventions

Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles.

Group II: Part 3a: ABBV-637 + Osimertinib Experimental Treatment 2 Interventions

Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles.

Group III: Part 2b: ABBV-637 + Docetaxel Experimental Treatment 2 Interventions

Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.

Group IV: Part 2a: ABBV-637 + Docetaxel Experimental Treatment 2 Interventions

Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.

Group V: Part 1: ABBV-637 Monotherapy Experimental Treatment 1 Intervention

Participants will receive escalating doses of ABBV-637 in 28-day cycles.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04721015

NCT04721015 | Study of Intravenous (IV) ABBV-637 Alone ... The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M20-111

Study of Intravenous (IV) ABBV-637 Alone or in ... The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with ...

3. dana-farber.org dana-farber.org/clinical-trials/21-528

A Phase 1 first in human study evaluating safety and ... ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10082298/

Five-Year Outcomes With Pembrolizumab Versus ... Objective response rate was 84.3% among 102 patients who completed 35 cycles of pembrolizumab and 15.2% among 33 patients who received second-course ...

5. targetedonc.com targetedonc.com/view/adcs-on-the-horizon-offer-hope-for-challenging-cancers

ADCs on the Horizon Offer Hope for Challenging Cancers The clinical benefit rate was 36% with stable disease lasting longer than 12 weeks.

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)03189-7/fulltext

1318MO First-in-human study of ABBV-637, an EGFR- ... ABBV-637 plus OSI showed clinical activity and a manageable safety profile in patients with RR NSCLC. Biomarker data suggest that response to ABBV-637 plus OSI ...

7. onclive.com onclive.com/view/dr-rotow-on-the-investigation-of-abbv-637-plus-osimertinib-in-egfr-mutated-nsclc

Dr Rotow on the Investigation of ABBV-637 Plus ... - OncLive The regimen also had a manageable safety profile in this patient population, though ongoing research is needed to confirm optimal biomarkers for ...