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LP-118

Phase 1

Philadelphia Positive Acute Lymphoblastic Leukemia | Small molecule | Oncology |Atrium Therapeutics, Inc.|Last Updated: Jun 5, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

LP-118 · 1 trial · 1 indication

Phase 1 1
NCT07614022A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)Philadelphia Positive Acute Lymphoblastic Leukemia
NOT YET_RECRUITING26 Analytics
PHASE1NOT YET_RECRUITING
A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)
Philadelphia Positive Acute Lymphoblastic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Estimation of the Maximum Tolerated Dose (MTD) for LP-118 (Dose Escalation)
The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).

Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.

Identification of the Recommended Phase 2 Dose (RP2D) LP-118 (Dose Expansion)
The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).

Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.

Secondary Endpoints

Overall Survival (OS).
At most 10 years.
Relapsed-Free Survival (RFS).
At most 10 years.
Event-Free Survival (EFS).
At most 10 years.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Combination of LP-118, ponatinib, dexamethasone, blinatumomab and methotrexateEXPERIMENTALLP-118 will be given as tablets of 10mg or 100mg during the induction II course only in combination with ponatinib, dexamethasone, methotrexate and blinatumomab. . Ponatinib, dexamethasone and methotrexate dosing will remain fixed, whereas LP-118 dosing will be dependent on the dose level to which a participant is assigned.

Interventions

NameTypeDescription
LP-118DRUGs LP-118 dosing will be dependent on the dose level to which a participant is assigned: * 50mg PO * 100mg PO * 200mg PO * 300mg PO
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Ability to understand and willingness to sign an IRB-approved informed consent. * Age ≥ 18 years at the time of consent. * ECOG Performance Status (PS) ≤ 2. * Histological or cytological confirmation of newly diagnosed CD19-positive Philadelphia-chromosome/BCR::ABL1-positive A...

Countries:United States
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Frequently asked questions about LP-118

What is LP-118 used for?

LP-118 is an investigational small molecule being studied for the treatment of Philadelphia Positive Acute Lymphoblastic Leukemia (Ph+ ALL) in adults. It is currently in Phase 1 clinical development.

Who is developing LP-118?

LP-118 is being developed by Atrium Therapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol RNA.

What phase is LP-118 in?

LP-118 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied in a Phase 1 trial for adults with newly diagnosed Ph+ ALL.

What clinical trials is LP-118 in?

LP-118 is being studied in a Phase 1 clinical trial with the identifier NCT07614022. The trial is evaluating LP-118 in combination with ponatinib, dexamethasone, and blinatumomab in adults with newly diagnosed, BCR::ABL1-positive acute lymphoblastic leukemia. The trial is not yet recruiting and has a planned enrollment of 26 participants.

Is LP-118 being studied in a randomized or blinded trial?

The Phase 1 clinical trial of LP-118 is not randomized and not double-blinded. It is an uncontrolled study, meaning there is no control group. The trial is open to all sexes and participants must be at least 18 years old.