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

Conditions

• Chronic Myeloid Leukemia
• Chronic Myeloid Leukemia, Chronic Phase

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TERN-701 — DRUG
  TERN-701 orally QD

Study Details

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).

Key Dates

Start date

Mar 26, 2024

Status verified

Jan 2026

Primary completion

Nov 30, 2029

Completion

May 31, 2030

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1- Dose Level 1 (160 mg) of TERN-701
  Dose Level 1 of TERN-701 dosed once daily.
• Experimental: Part 1- Dose Level 2 (320 mg) of TERN-701
  Dose Level 2 of TERN-701 dosed once daily.
• Experimental: Part 1- Dose Level 3 (400 mg) of TERN-701
  Dose Level 3 of TERN-701 dosed once daily.
• Experimental: Part 1- Dose Level 4 (500 mg) of TERN-701
  Dose Level 4 of TERN-701 dosed once daily.
• Experimental: Part 2 - Dose 1 (320 mg)
  Dose 1 was selected based on the totality of safety, PK, PD and efficacy data from Part 1. TERN-701 administered once daily.
• Experimental: Part 2 - Dose 2 (500 mg)
  Dose 2 was selected based on the totality of safety, PK, PD and efficacy data from Part 1. TERN-701 administered once daily.
• Experimental: Part 2m - 500 mg Dose
  Dose for Part 2m was selected based on the totality of safety, PK, PD and efficacy data from Part 1 and nonclinical data. TERN-701 is administered once daily.

Primary Outcome Measure

Part 1 - Incidence of Dose Limiting Toxicities during the first cycle of treatment [ Time Frame: First cycle is 28 days ]

Central Contacts

• Study Director
  650-525-5535
  [email protected]

Locations (18)

Find similar trials in Birmingham, AL

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