Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors

Part of paid clinical trials in West Valley City, Utah.

Sponsor
Lantern Pharma Inc.
Study ID
NCT06132503
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Relapsed or Refractory Lymphomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LP-284 — DRUG
    LP-284 is a small molecule alkylating agent causing tumor cell death through DNA damage.

Study Details

The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of LP-284 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) in patients with relapsed or refractory (R/R) lymphomas and solid tumors. The secondary objectives are to characterize the pharmacokinetics (PK) of LP-284 and to assess clinical activity of LP-284.

Key Dates

Start date
Jan 3, 2023
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-284
    The Phase 1a dose escalation portion of the study will identify the maximum tolerated dose (MTD) and/or optimal dose(s) of LP-284 as the RP2D, based on all available safety, PK, PD, and/or preliminary efficacy data. Phase 1b will consist of the dose expansion portion in a separate cohort(s) of patients to further evaluate the safety of LP-284 at the RP2D and obtain preliminary estimates of clinical activity of LP-284 in patients with DLBCL and MCL.

Primary Outcome Measure

Phase 1a: To evaluate the safety and tolerability of escalating doses of LP-284 [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
START Mountain RegionWest Valley CityUtah84119
Marie Asay
[email protected]
801-907-4770
William B McKean, MD (PRINCIPAL_INVESTIGATOR)

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By research site
START Mountain Region· West Valley City, UT

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