A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
Phase 1 trial tests new cancer drug AB598 alone and with other treatments.
Plain English Summary
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers is a Phase 1 clinical trial sponsored by Arcus Biosciences, Inc. studying Advanced Cancer, Advanced Malignancies, Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer (GEJ), Head and Neck Squamous Cell Carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer. This trial is testing a new drug called AB598, by itself and in combination with other cancer treatments. It is for adults with advanced cancers that have not responded to standard treatments. Participants will receive study drugs and be monitored for side effects and how well the treatment works. Standard chemotherapy or other targeted therapies are current alternatives for advanced cancers. The trial aims to enroll 40 participants.
Official Summary
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with advanced solid tumors that have spread or cannot be removed by surgery. Patients must have a performance status score indicating they are generally well enough to carry out daily activities. Individuals with certain autoimmune diseases or who have had recent surgery or radiation may not be eligible. Specific criteria apply for different groups, including those with advanced gastric or GEJ adenocarcinoma. This trial is studying Advanced Cancer, Advanced Malignancies, Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer (GEJ), Head and Neck Squamous Cell Carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how safe the drug is by tracking side effects and determining the highest dose that can be given without causing unacceptable harm. The specific primary outcome measures are: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Up to 2 years); Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs) (Up to 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial is important because it explores a new treatment option for patients with advanced cancers who have limited alternatives, potentially filling a gap in current therapies. This research targets Advanced Cancer, Advanced Malignancies, Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer (GEJ), Head and Neck Squamous Cell Carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer, where improved treatment options are needed.
Investor Insight
This early-phase trial is investigating a novel drug, AB598, in a market with significant unmet needs for advanced cancers, suggesting potential for future development if safety and efficacy are demon Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific drugs being tested, potential side effects, and what to expect during the trial. Participation involves regular clinic visits for drug administration, blood tests, scans, and biopsies to monitor your health and the treatment's effect. Be prepared for potential side effects and discuss any new or worsening symptoms with your healthcare team immediately. The trial is being conducted at 15 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: SEQUENTIAL
- Masking: NONE
- Enrollment: 40 participants
Interventions
- DRUG: AB598 — Administered as specified in the treatment arm
- DRUG: Zimberelimab — Administered as specified in the treatment arm
- DRUG: Fluorouracil — Administered as specified in the treatment arm
- DRUG: Leucovorin — Administered as specified in the treatment arm
- DRUG: Oxaliplatin — Administered as specified in the treatment arm
Primary Outcomes
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Up to 2 years)
- Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs) (Up to 2 years)
Secondary Outcomes
- Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma (Predose, Up to 4 hours post dose)
- Maximum Concentration (Cmax) in Whole Blood and Plasma (Predose, Up to 4 hours post dose)
- Time to Maximum Concentration (Tmax) in Whole Blood and Plasma (Predose, Up to 4 hours post dose)
- Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598 (Up to 2 years)
- Objective Response Rate (ORR) (Up to 2 years)
Full Eligibility Criteria
Key Inclusion Criteria: * Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Prior systemic radiation or whole brain radiation therapy must have been completed at least 4 weeks before investigational product (IP) administration. Other palliative radiotherapy must be completed 2 weeks before investigational product administration, if radiation therapy-related AEs have resolved to Grade ≤ 1. * Monotherapy-specific criteria for dose escalation and PD cohorts: * Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. * Pharmacodynamic Cohorts: Participants may have any pathologically confirmed advanced or metastatic solid tumors for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. Participants must be able to undergo collection of a fresh frozen biopsy during screening, as well as provide an on-treatment fresh frozen biopsy. * Dose Expansion cohort criteria: * Histologically confirmed, documented diagnosis of HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. * No prior systemic treatment for locally advanced unresectable or metastatic disease. * Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease. Key Exclusion Criteria: * Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study * Underlying medical conditions or AEs that, in the investigator or sponsor's opinion, will make the administration of the study drugs hazardous * Any active or documented history of autoimmune disease including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment * History of trauma or major surgery within 28 days prior to the first dose of study drug * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment with certain protocol specified exceptions Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial Locations
- Mayo Clinic Arizona, Phoenix, Arizona, United States
- Mayo Clinic Florida, Jacksonville, Florida, United States
- Lake City Cancer Care, LLC., Lake City, Florida, United States
- Affinity Health Hope and Healing Cancer Services, LLC, Hinsdale, Illinois, United States
- Karmanos Cancer Institute, Detroit, Michigan, United States
- Mayo Clinic Rochester, Rochester, Minnesota, United States
- Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
- Gabrail Cancer Center (GCC) Canton Facility, Canton, Ohio, United States
- University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
- Next Oncology Dallas, Irving, Texas, United States
- ...and 5 more locations
Frequently Asked Questions
What is clinical trial NCT05891171?
NCT05891171 is a Phase 1 INTERVENTIONAL study titled "Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers." It is currently active, not recruiting and is sponsored by Arcus Biosciences, Inc.. The trial targets enrollment of 40 participants.
What conditions does NCT05891171 study?
This trial investigates treatments for Advanced Cancer, Advanced Malignancies, Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer (GEJ), Head and Neck Squamous Cell Carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer. The primary condition under study is Advanced Cancer.
What treatments are being tested in NCT05891171?
The interventions being studied include: AB598 (DRUG), Zimberelimab (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG). Administered as specified in the treatment arm
What does Phase 1 mean for NCT05891171?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT05891171?
This trial is currently "Active, Not Recruiting." It started on 2023-10-13. The estimated completion date is 2026-03.
Who is sponsoring NCT05891171?
NCT05891171 is sponsored by Arcus Biosciences, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05891171?
The trial aims to enroll 40 participants. The trial status is active, not recruiting.
How is NCT05891171 designed?
This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.
What are the primary outcomes being measured in NCT05891171?
The primary outcome measures are: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Up to 2 years); Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs) (Up to 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05891171 being conducted?
This trial is being conducted at 15 sites, including Phoenix, Arizona; Jacksonville, Florida; Lake City, Florida; Hinsdale, Illinois and 11 more sites (United States, Australia, Taiwan).
Where can I find official information about NCT05891171?
The official record for NCT05891171 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05891171. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05891171 testing in simple terms?
This trial is testing a new drug called AB598, by itself and in combination with other cancer treatments. It is for adults with advanced cancers that have not responded to standard treatments.
Why is this trial significant?
This trial is important because it explores a new treatment option for patients with advanced cancers who have limited alternatives, potentially filling a gap in current therapies.
What are the potential risks of participating in NCT05891171?
Common side effects may include fatigue, nausea, diarrhea, and skin reactions. More serious side effects can occur, such as severe allergic reactions, organ damage, or effects on blood counts. The study drugs may also interact with other medications you are taking. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05891171?
Ask your doctor about the specific drugs being tested, potential side effects, and what to expect during the trial. Participation involves regular clinic visits for drug administration, blood tests, scans, and biopsies to monitor your health and the treatment's effect. Be prepared for potential side effects and discuss any new or worsening symptoms with your healthcare team immediately. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05891171 signal from an investment perspective?
This early-phase trial is investigating a novel drug, AB598, in a market with significant unmet needs for advanced cancers, suggesting potential for future development if safety and efficacy are demon This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive study drugs and be monitored for side effects and how well the treatment works. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.