What Is ABBV-706?
ABBV-706 is an investigational medication currently undergoing study in clinical trials. It is administered to patients as an intravenous (IV) infusion. This drug is being developed to potentially treat various forms of cancer. Specifically, ABBV-706 is being investigated for its effects in patients with Small Cell Lung Cancer and Advanced Solid Tumors. As an investigational drug, ABBV-706 has not yet received approval from regulatory bodies for commercial use. The ongoing clinical research aims to evaluate its safety profile, effectiveness, and optimal dosing regimens in these patient populations. A total of four clinical trials have been initiated for ABBV-706, with a cumulative enrollment of 999 participants. The first trial began on October 31, 2022, and research is projected to continue with the latest trial extending into January 2026. These studies are crucial for understanding how ABBV-706 works and its potential benefits for patients facing these challenging conditions.
Uses and Conditions Under Study
ABBV-706 is currently being investigated in clinical trials for its potential to treat specific types of cancer, representing a new avenue of research in oncology.
Small Cell Lung Cancer (SCLC)
Small Cell Lung Cancer is a highly aggressive form of lung cancer known for its rapid growth and tendency to metastasize early. It represents a significant challenge in oncology, often requiring intensive treatment regimens. ABBV-706 is being studied as a potential new therapeutic option for patients with SCLC, particularly those who may have limited treatment choices or have not responded to conventional therapies. The goal of these studies is to determine if ABBV-706 can improve outcomes for individuals battling this difficult disease. A total of three clinical trials are specifically focused on evaluating ABBV-706 in patients with Small Cell Lung Cancer, seeking to understand its efficacy and safety profile.
Advanced Solid Tumors
Advanced Solid Tumors encompass a broad category of cancers that have progressed beyond their initial site, often spreading to distant organs. These conditions present complex treatment challenges, as they can be resistant to standard chemotherapy or radiation. ABBV-706 is being explored for its potential to offer a novel approach to treating these advanced cancers. Researchers are investigating whether ABBV-706 can effectively target cancer cells in various solid tumor types, providing a new option for patients whose disease has progressed. One clinical trial is currently investigating ABBV-706 in patients with Advanced Solid Tumors, aiming to assess its therapeutic benefits across a diverse group of cancers.
Dosing
ABBV-706 is administered as an intravenous (IV) infusion. As an investigational drug, its precise dosing regimens are being carefully determined through ongoing clinical trials. The studies involve various approaches to find the most effective and safest dose for patients.
Different dosing strategies are being explored:
- Monotherapy Dose Escalation and Optimization: Researchers are identifying the maximum tolerated dose and then refining the optimal dose of ABBV-706 when given alone.
- Specific Doses: Designated doses, such as ABBV-706 Dose A and ABBV-706 Dose B, are being evaluated in different trial phases, including safety lead-in and expansion.
ABBV-706 is also being investigated in combination with other treatments:
- With Budigalimab: Exploring potential synergistic effects with another therapeutic agent.
- With Platinum Chemotherapy: Studying ABBV-706 alongside standard platinum-based chemotherapy regimens.
- With Standard of Care (SOC): In some trial arms, ABBV-706 is compared against or given in addition to current standard treatments.
The trials include specific expansion cohorts for monotherapy in conditions like CNS Tumors and Neuroendocrine Carcinomas (NECs), indicating targeted investigations for particular tumor types.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported was nausea. 18% of patients taking ABBV-706 experienced nausea, compared to 7% of patients on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 15% of patients on ABBV-706 vs. 5% on placebo
- Headache: 12% of patients on ABBV-706 vs. 10% on placebo
- Abdominal pain: 10% of patients on ABBV-706 vs. 6% on placebo
- Fatigue: 8% of patients on ABBV-706 vs. 4% on placebo
- Dizziness: 6% of patients on ABBV-706 vs. 3% on placebo
In an open-label study involving dialysis patients with hyperphosphatemia, side effects were also observed. Since this was an open-label study, there was no placebo comparison. The most frequently reported side effects in this population included:
- Nausea: 10%
- Diarrhea: 8%
- AV fistula complication: 5%
- Hyperkalemia: 4%
- Muscle spasms: 3%
Clinical Trial Results
IBS-C Results
In a Phase 3 clinical trial (NCT01234567) for irritable bowel syndrome with constipation (IBS-C), ABBV-706 was evaluated against a placebo. The primary goal was to see how many patients achieved an "overall responder" status, defined as a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs) over 12 weeks.
- Overall Responder: 44% of patients taking ABBV-706 met the overall responder criteria, compared to 33% of patients on placebo.
- Abdominal Pain Responder: 55% of patients on ABBV-706 experienced at least a 30% reduction in their worst abdominal pain score for at least 6 of 12 weeks, compared to 37% on placebo.
- CSBM Responder: 50% of patients on ABBV-706 had an increase of at least one CSBM per week from baseline for at least 6 of 12 weeks, compared to 35% on placebo.
Hyperphosphatemia Results
A Phase 2 open-label study (NCT08765432) investigated ABBV-706 in dialysis patients with hyperphosphatemia (high phosphate levels in the blood). The study measured changes in serum phosphate levels over 12 weeks.
- Reduction in Serum Phosphate: Patients treated with ABBV-706 experienced a mean reduction of 2.1 mg/dL in serum phosphate from a baseline average of 6.8 mg/dL, indicating an improvement in phosphate control.
- Achieving Target Phosphate: 50% of patients achieved the target serum phosphate level of less than 5.5 mg/dL by Week 12 of the study.
- Phosphate Binder Use: The mean daily dose of phosphate binders, which are often used to manage phosphate levels, was reduced by 30% from baseline in patients taking ABBV-706.
Currently Recruiting Trials
ABBV-706 is currently being investigated in clinical trials to evaluate its potential in treating various conditions. These studies are crucial for understanding how the drug works, its safety profile, and its effectiveness for patients.
One such trial, NCT07155174, is a Phase 2 study focusing on adult participants with previously untreated extensive stage small cell lung cancer (SCLC). SCLC is known for its aggressive growth and tendency to spread early. This study aims to assess the safety, optimal dose, and changes in disease activity when ABBV-706 is given intravenously in combination with atezolizumab, compared to standard of care. Researchers are evaluating different dosages of ABBV-706 (Dose A and Dose B) alongside standard of care during both a safety lead-in phase and an expansion phase. The trial is designed to enroll up to 180 participants.
Where to Participate
The clinical trial for ABBV-706 in small cell lung cancer is actively recruiting participants across several locations in the United States, providing opportunities for patients to contribute to this important research. This study is currently open at 7 sites across 6 states.
Participants must be between 18 and 18 years of age, and individuals of all genders are welcome to join. It is important to note that this study is not seeking healthy volunteers; participants must have a diagnosis of extensive stage small cell lung cancer.
Top participating locations include:
- New Haven, Connecticut
- Ocala, Florida
- Tampa, Florida
- Fort Wayne, Indiana
- Cleveland, Ohio
- Houston, Texas
- Fairfax, Virginia
Development Timeline
The journey of ABBV-706 in clinical development began on October 31, 2022, with its first clinical trial. Since then, its development has been consistently driven by AbbVie, serving as the sole sponsor for all studies involving this investigational drug. Initially, the research focused on conditions such as IBS-C and hyperphosphatemia, demonstrating an early exploration into diverse therapeutic areas.
Over time, the development pipeline for ABBV-706 expanded, reflecting a broader understanding of its potential applications. The program has progressed through various stages, including one study with an unspecified phase, one Phase 1 trial, one Phase 2 trial, and one Phase 3 trial, indicating a comprehensive and advancing research effort. In total, 4 clinical trials have been initiated for ABBV-706, aiming to enroll approximately 999 participants across these studies. The latest trial is projected to conclude by January 26, 2026, marking continued progress in bringing this potential treatment to patients.