ARTS-021 for Advanced Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Avenzo Therapeutics, Inc.
Must not be taking: CDK2 inhibitors, PKMYT1 inhibitors
Disqualifiers: Active CNS metastases, Unstable cardiac, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong or moderate CYP3A4 inhibitors or inducers before starting the study medication. If you're on these types of medications, you may need to discuss alternatives with your doctor.
What data supports the effectiveness of the drug ARTS-021 for advanced cancer?
The research suggests that chemotherapy, including drugs like paclitaxel and carboplatin, can improve survival and quality of life in patients with advanced non-small cell lung cancer. Although ARTS-021 is not specifically mentioned, similar treatments have shown benefits, indicating that ARTS-021 might also be effective in treating advanced cancer.
12345Eligibility Criteria
Adults (18+) with advanced solid tumors where standard treatments are ineffective, inappropriate, or unsafe. Participants must have measurable disease, not be pregnant or breastfeeding, and agree to use effective birth control. They should be in good physical condition (ECOG 0-1) with proper organ function and able to take oral medication.Inclusion Criteria
My liver, kidneys, blood, and clotting functions are all working well.
I am fully active or can carry out light work.
Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 6 months following the last dose of study treatment
+7 more
Exclusion Criteria
I had major surgery less than 4 weeks before starting ARTS-021.
I haven't had a heart attack or significant heart disease in the last 6 months.
I have not taken steroids or had immunodeficiency issues in the last week.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase 1 Treatment
Dose-escalation phase to assess safety and tolerability of AVZO-021 and determine the recommended phase 2 dose (RP2D) as monotherapy and combination therapy
Approximately 16 months
28-day cycles
Phase 2 Treatment
Dose-expansion phase to assess the antitumor activity of AVZO-021 as monotherapy and combination therapy
Approximately 52 months
28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Approximately 76 months
Participant Groups
The trial is testing ARTS-021's safety and effectiveness against advanced solid tumors. It involves different phases: monotherapy dose escalation for various cancers; combination dose expansion for specific breast cancer types and ovarian cancer; both using additional drugs like Palbociclib.
4Treatment groups
Experimental Treatment
Group I: Phase 2, monotherapy (Part 2A)Experimental Treatment1 Intervention
Oral doses of AVZO-021 in 28-day cycles at the RP2D determined in Part 1A.
Group II: Phase 2, combination (Parts 2B and 2C)Experimental Treatment8 Interventions
Oral doses of AVZO-021 in 28-day cycles at the RP2D determined in Parts 1B/1C, in combination with:
2B1) fulvestrant
2B2) palbociclib plus either fulvestrant or letrozole
2B3) ribociclib plus either fulvestrant or letrozole
2B4) abemaciclib plus either fulvestrant or letrozole
2B5) sacituzumab govitecan-hziy
2C) carboplatin
Group III: Phase 1, monotherapy (Part 1A)Experimental Treatment1 Intervention
Escalating doses of once daily, oral AVZO-021 in 28-day cycles.
Group IV: Phase 1, combination (Parts 1B and 1C)Experimental Treatment8 Interventions
Escalating doses of once daily, oral AVZO-021 in 28-day cycles starting at least 1 DL below the monotherapy MTD/RP2D dose in combination with:
1B1) fulvestrant
1B2) palbociclib plus either fulvestrant or letrozole
1B3) ribociclib plus either fulvestrant or letrozole
1B4) abemaciclib plus either fulvestrant or letrozole
1B5) sacituzumab govitecan-hziy
1C) carboplatin
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale Cancer CenterNew Haven, CT
Oklahoma UniversityOklahoma City, OK
University Hospitals Cleveland Medical CenterCleveland, OH
Florida Cancer SpecialistsSarasota, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Avenzo Therapeutics, Inc.Lead Sponsor
Allorion Therapeutics IncLead Sponsor
References
Treatment of performance status 2 patients with advanced non-small-cell lung cancer: what we know and what we don't know. [2009]Performance status (PS)2 patients with advanced non-small-cell lung cancer have been historically excluded from clinical trials, and scant data are available to guide clinical practice. As in other types of cancer, PS represents a recognized prognostic factor, and the life expectancy for PS2 patients is nearly half that of the PS0/1 patients. Even if single-agent chemotherapy still remains the reference treatment, recent data suggest a role for new agents or combination chemotherapy in these patients. A large Phase III randomized trial comparing single-agent versus combination chemotherapy is strongly needed.
Do all patients with advanced non-small-cell lung cancer benefit from cisplatin-based combination therapy? [2020]Platinum-based chemotherapy has been shown to be effective in improving survival and quality of life in advanced non-small-cell lung cancer (NSCLC) patients. The objective of this study was to identify patients more likely to benefit from chemotherapy in order to avoid the indiscriminate treatment of all patients.
Pemetrexed clinical studies in performance status 2 patients with non-small cell lung cancer (Review). [2023]Because poor performance status (PS) is an independent prognostic factor in non-small cell lung cancer (NSCLC), PS scores are widely used by oncologists to make treatment decisions. Advanced NSCLC patients with an Eastern Cooperative Oncology Group PS of 2 have poor prognoses and are frequently excluded from clinical trials. This article reviews the efficacy and safety of pemetrexed in this patient group. We identified English-language literature (through March 2015) involving completed and ongoing studies through searches of PubMed, meeting abstracts, ClinicalTrials.gov and the European Clinical Trials Register; search terms included 'pemetrexed,' 'NSCLC' and 'PS2'. Only studies reporting ≥1 subset analysis of PS2 patients receiving pemetrexed were chosen. Our search identified a total of ten pemetrexed studies in PS2 patients. Eight studies included only chemonaive patients, one study included both chemonaive patients and patients with one prior chemotherapy regimen and one study included only patients with one prior regimen. In subset analyses in these studies, PS2 patients had worse outcomes than PS0-1 patients regardless of treatment. In a phase 3 study, chemonaive advanced NSCLC patients with PS2 receiving pemetrexed‑carboplatin versus pemetrexed experienced improved overall survival [hazard ratio (HR)=0.62; P=0.001], progression-free survival (HR=0.46; P
Role of chemotherapy in patients with poor performance status and advanced non-small cell lung cancer. [2019]The treatment of advanced non-small cell lung cancer remains an important area of research, with many questions about the use of chemotherapy still unanswered. It is now recognized that chemotherapy improves survival and alleviates disease-related symptoms in the population with advanced non-small cell lung cancer. However, it is unknown whether these benefits apply to patients with poor performance status (PS). These patients (Eastern Cooperative Oncology Group PS2) have inferior outcomes compared with more fit patients, and historically, they have been excluded from clinical trials. In other trials with broader eligibility, PS2 patients comprised fewer than 20% of the study populations. These factors have led to difficulty in ascertaining true outcomes in the PS2 patient population. However, the PS2 population accounts for a significant portion (up to 30% to 40%) of patients in oncology practice, and emerging data suggest that these patients may in fact garner benefits, such as prolonged survival and improved quality of life, from chemotherapy. Studies with single-agent vinorelbine or paclitaxel have shown improved survival with chemotherapy versus supportive care that remain significant when stratified by PS. A recent subset analysis of PS2 patients enrolled in a trial comparing carboplatin and paclitaxel with single-agent paclitaxel suggests that combination chemotherapy is a feasible option and is potentially preferable to single-agent therapy. Importantly, several analyses have shown that toxicity is not necessarily worse in this population compared with more fit patients. Because optimal agents or combinations have not been defined, novel strategies and therapeutics are urgently needed in this population.
Paclitacxel and carboplatin in advanced non-small-cell lung cancer. [2015]To evaluate the efficacy and toxicity of the combination of paclitacxel and carboplatin on advanced non-small-cell lung cancer (NSCLC). Forty-eight patients with locally advanced (stage IIIb) or metastatic (stage IV) NSCLC were enrolled into the study. The patients received paclitacxel 55-60 mg/m(2) on day 1, 8, 15, carboplatin at an AUC of 5 on day 1, administreted in 28-day cycle. An objective response was obtained in 37.5% of patients (two complete and 16 partial responses). Significant difference existed between the naive patients and pretreated patients (46.4% vs. 25.0%, P