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NCT06163430 · ClinicalTrials.gov registry record · Phase 1

A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)

A Phase 1 study of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, Chronic Phase, sponsored by Terns.

Recruiting
Registry status
Phase 1
Development phase
180
Enrollment target
20
Study locations

NCT06163430: Recruiting Phase 1 study of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, Chronic Phase, sponsored by Terns.

NCT06163430 is a Phase 1 study of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, Chronic Phase that is actively recruiting participants, run by Terns. The registered enrollment target is 180 participants, below the 205-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06163430, a Phase 1 study of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, Chronic Phase, is actively recruiting participants, sponsored by Terns.

RECRUITING
Registry status
Phase 1
Development phase
180 participants
Enrollment target
20
Study locations

Study Summary

The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML). The study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily. Part 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of 2 recommended dose levels for expansion selected from Part 1. Part 2m (mutation cohort) will further evaluate the efficacy and safety of 500mg of TERN-701 in previously treated CP-CML participants with certain resistance mutations. In both Part 1 and Part 2, participants will receive continuous once daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2 (Part 1 only), C1D8, C1D15, and C1D16 (Part 1 only), followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter. Approximately 180 participants could be enrolled in this trial, up to 80 participants in Part 1 (dose escalation), including optional backfill cohorts, approximately 80 participants in Part 2 (randomized dose expansion), and approximately 20 participants in Part 2m (mutation cohort). All participants will receive active trial intervention. Four dose-level cohorts have been evaluated in Part 1; two dose levels will be evaluated in Part 2 (Randomized Dose Expansion), and one dose level will be evaluated in Part 2m (mutation cohort).

Primary Outcome

Determination of the Maximum Tolerated Dose (MTD) and recommended doses for expansion cohorts of TERN-701.

Conditions Studied

Chronic Myeloid Leukemia Chronic Myeloid Leukemia, Chronic Phase

Interventions

  • DRUG TERN-701

Study Locations (20)

Florida

  • Florida Cancer Specialists - South Region Research Office - Fort Myers
  • Florida Cancer Affiliates - Ocala - Ocala
  • Florida Cancer Specialists - North Region Research Office - St. Petersburg
  • Florida Cancer Specialists - East Region Research Office - West Palm Beach

Oregon

  • Willamette Valley Cancer Institute and Research Center - Eugene
  • Oregon Health & Science University - Portland

Alabama

  • University of Alabama Medicine (UAB Medicine) - Birmingham

Arizona

  • Banner MD Anderson Cancer Center - Gilbert

California

  • UC Irvine Health - Orange

Colorado

  • Rocky Mountain Cancer Centers, LLP - Lone Tree

Georgia

  • Georgia Cancer Center at Augusta University - Augusta

New York

  • Memorial Sloan Kettering Cancer Center - Main Campus - New York

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2024-03-26
Est. Completion 2030-05-31
Phase Phase 1
Terns

5 total trials

What NCT06163430 shows while recruiting

NCT06163430 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 205-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (12% lower).

The record links to 2 conditions, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which TERN-701 is the first listed.

NCT06163430 names 20 study sites across 16 states, led by Florida, Oregon, Alabama.

Frequently Asked Questions

What is clinical trial NCT06163430 about?

NCT06163430 is a clinical study titled "A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)". The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML). The study has two parts: Part 1...

What is the current status of trial NCT06163430?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2024-03-26. Estimated completion is 2030-05-31.

What conditions does trial NCT06163430 study?

This clinical trial studies the following conditions: Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic Phase.

What interventions are being tested in trial NCT06163430?

The interventions under investigation include: TERN-701 (DRUG).

Who is sponsoring clinical trial NCT06163430?

This trial is sponsored by Terns, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06163430 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Chronic Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06163430's enrollment target sits among peer trials

180 9th of 35 higher than 27 of 35 other Chronic Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06163430

Source: ClinicalTrials.gov NCT06163430, the US trial registry maintained by the National Library of Medicine. NCT06163430 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.