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AS-1763 for Chronic Lymphocytic Leukemia

Phase 1

Recruiting

Research Sponsored by Carna Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Histologically confirmed B-cell malignancy, including CLL/SLL, WM, MCL, MZL, or FL. Patients must have failed or are intolerant to ≥2 prior lines of systemic therapy

Must not have

Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months before planned start of AS-1763, or prolongation of the QT interval corrected for heart rate using Fridericia's Formula (QTcF) >470 msec on at least 2 of 3 consecutive ECGs, and mean QTcF >470 msec on all 3 ECGs, during Screening

Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug to treat a type of blood cancer in patients who have already tried other treatments.

Who is the study for?

This trial is for adults over 18 with certain B-cell cancers like CLL/SLL or NHL who have tried at least two other treatments without success. They must be able to swallow pills, perform daily activities with minimal help, and use effective birth control. People can't join if they have cancer in the brain, uncontrolled infections or autoimmune diseases, recent heart issues, are pregnant or breastfeeding, HIV positive, or have had recent major surgery.

What is being tested?

The study tests AS-1763—an oral medication—on patients with specific types of blood cancers that haven't responded well to previous therapies. It's an early-phase trial (Phase 1b) where everyone gets the same treatment to see how safe it is and what effects it has.

What are the potential side effects?

Potential side effects aren't detailed here but could include typical reactions seen with cancer medications such as nausea, fatigue, allergic reactions to ingredients in AS-1763, liver problems due to hepatic function requirements for eligibility criteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is a type of B-cell malignancy and I've tried at least 2 treatments that didn't work or couldn't tolerate.

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have serious heart issues or a recent heart attack.

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I do not have any ongoing serious infections.

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I have another cancer type but it's in remission and I'm expected to live more than 2 years.

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I am on warfarin for blood clot treatment.

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I don't have lasting side effects from previous treatments, except for hair loss.

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My condition does not improve with blood transfusions.

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I have not had major surgery in the last 4 weeks.

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I am not taking strong drugs that affect liver enzyme CYP3A4.

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I have previously been treated with specific noncovalent BTK inhibitors.

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I do not have a condition that affects how my body absorbs medication.

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My condition has changed into a more aggressive form.

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I haven't taken proton pump inhibitors in the last 7 days.

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I am not taking strong medication for cancer resistance.

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I have not had a stem cell transplant or CAR-T therapy in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD)

Overall response rate (ORR) as assessed by investigator

Secondary study objectives

Area under the plasma concentration versus time curve (AUC) of docirbrutinib

Best overall response as assessed by investigator

Duration of response as assessed by investigator

+6 more

Other study objectives

Proportion of patients with BTK and PLCG2 gene mutation before and after disease progression

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

Cohort 1: CLL/SLL patients, Cohort 2: B-cell NHL patients, Cohort 3: CLL/SLL or B-cell NHL patients with prior treatment with pirtobrutinib (Jaypirca) for an approved indication Patients will self-administer docirbrutinib oral tablet for 24 cycles (1 cycle = 28 days). Dose levels will be determined based on the result of dose escalation part.

Group II: Dose EscalationExperimental Treatment1 Intervention

Dose escalation (3+3 design) and determination of MTD and DLTs CLL/SLL or B-cell NHL patients will self-administer docirbrutinib oral tablet at multiple dose levels twice daily for 24 cycles (1 cycle = 28 days).

0 / 17Eligibility criteria met