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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07614022A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)PHASE1 NOT YET_RECRUITING 26Oct 1, 2026Mar 1, 2030Jun 5, 20262 United States
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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 — 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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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07614022lastUpdatePostDate: changed
LOWJun 5, 2026NCT07614022lastUpdatePostDate: changed
LOWJun 5, 2026NCT07614022lastUpdatePostDate: changed
LOWJun 5, 2026NCT07614022lastUpdatePostDate: changed
LOWMay 30, 2026NCT07614022NEW_TRIAL: changed
LOWMay 30, 2026NCT07614022NEW_TRIAL: changed