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CDK 2 Inhibitor

ARTS-021 for Advanced Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Avenzo Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 34 months
Awards & highlights

Study Summary

This trial tests a new oral medication, ARTS-021, to see if it's safe and can help treat advanced solid tumors. It may inhibit a protein called CDK 2.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of ARTS-021 may include typical reactions related to CDK inhibitors such as fatigue, nausea, low blood cell counts leading to increased infection risk, liver issues, hair loss (alopecia), neuropathy but specifics will become clearer as the trial progresses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 34 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 34 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of Recommended Phase 2 Dose (RP2D)
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and laboratory abnormalities
Objective Response Rate (ORR)
+4 more
Secondary outcome measures
PK Parameters: Accumulation ration (Rac)
PK Parameters: Apparent clearance (CL/F)
PK Parameters: Apparent volume of distribution during terminal phase (Vz/F)
+6 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 2, Part 2b: Cohort 2CExperimental Treatment2 Interventions
Once daily oral doses of ARTS-021 at the RP2D in combination with carboplatin until disease progression or toxicity.
Group II: Phase 2, Part 2b: Cohort 2BExperimental Treatment4 Interventions
Once daily oral doses of ARTS-021 at the RP2D in combination with either palbociclib plus fulvestrant or palbociclib plus letrozole until disease progression or toxicity.
Group III: Phase 2, Part 2a: Cohort 2AExperimental Treatment1 Intervention
Once daily oral doses of ARTS-021 at the MTD/RP2D until disease progression or toxicity.
Group IV: Phase 1, Part 1b: Cohort 1BExperimental Treatment4 Interventions
Once daily oral doses of ARTS-021 at 1 to 2 dose levels below the MTD/RP2D (starting dose [DL 0]) followed by dose escalation to the MTD/RP2D (DL 1) or dose de-escalation to 2 to 3 dose levels below the MTD/RP2D in combination with either palbociclib plus letrozole or palbociclib plus letrozole. Each cycle is 28 days for ARTS-021.
Group V: Phase 1, Part 1a: Cohort 1CExperimental Treatment2 Interventions
Once daily oral doses of ARTS-021 at 1 to 2 dose levels below MTD/RP2D determined in Part 1a (starting dose [DL 0]) followed by dose escalation to the MTD/RP2D (DL 1) or dose de-escalation to 2 or 3 dose levels below the MTD/RP2D in combination with carboplatin. Each cycle is 28 days for ARTS-021.
Group VI: Phase 1, Part 1a: Cohort 1AExperimental Treatment1 Intervention
Once daily (QD), oral doses of ARTS-021 until intolerable toxicities to determine the MTD/RP2D. Each cycle is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib 125mg
2016
Completed Phase 3
~700
Letrozole 2.5mg
2019
Completed Phase 4
~840
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Avenzo Therapeutics, Inc.Lead Sponsor
Allorion Therapeutics IncLead Sponsor
1 Previous Clinical Trials
76 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still a possibility to become involved in this scientific investigation?

"Yes, as is evidenced on clinicaltrials.gov, this research initiative which was initially posted in August of 2023 is still actively recruiting patients. 192 volunteers are required from a single site to complete the study."

Answered by AI

What is the aggregate number of individuals enrolled in this clinical trial?

"Affirmative. According to the information uploaded onto clinicaltrials.gov, this research initiative is recruiting participants. The study was first available on August 30th 2023 and was most recently amended on September 28th 2023. 192 individuals must be enrolled from a single site for the trial to continue as planned."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of ARTS-021 in Patients With Advanced Solid Tumors
2023. "Study of ARTS-021 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05867251.
~128 spots leftby Oct 2025
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