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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 76 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 76 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 76 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 76 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of Recommended Phase 2 Dose (RP2D) (Phase 1)

Duration of response (DOR) (Phase 2)

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Treatment7 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 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 Treatment7 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 1C) carboplatin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole

2002

Completed Phase 4

~3590

Ribociclib

2018

Completed Phase 3

~2420