LP-184 Shows Favorable Safety, Pharmacokinetics in Advanced Solid Tumors

The rates of dose discontinuations, interruptions, or delays because of treatment-related adverse effects were low, with most cases being grade 1 or 2 in severity.

All primary end points of a phase 1a clinical trial (NCT05933265) were met, with LP-184 demonstrating a favorable safety and tolerability profile, as well as a promising pharmacokinetic (PK) profile, among patients with advanced relapsed/refractory solid tumors, according to a news release from the drug’s developer, Lantern Pharma.1

Specifically, the investigational agent displayed a robust safety profile, with no dose-limiting toxicities observed in most cohorts. Additionally, the rates of dose discontinuations, interruptions, or delays because of treatment-related adverse effects (TRAEs) were low, with most cases being grade 1 or 2 in severity. According to the release, the low incidence of grade 3 TRAEs makes LP-184 optimal for assessment as monotherapy or in combination with PARP inhibition or immunotherapies.

Furthermore, at 8 dose levels starting at 0.25 mg/kg, therapeutic concentrations were achieved, supporting optimization for subsequent trials. According to the developers, these observations may enable the advancement of biomarker-enriched populations identified through their RADR® AI platform.

“On behalf of our dedicated team, we extend our sincere gratitude to the patients, families, investigators, and clinical staff whose commitment drove the success of our phase 1a LP-184 trial, establishing a robust safety profile with encouraging signals of activity at therapeutic doses,” Panna Sharma, chief executive officer of Lantern Pharma, stated in the news release.1 “Leveraging our RADR AI platform, we are now positioning LP-184 for targeted phase 1b and phase 2 studies. Our goals are to position LP-184 to address critical unmet needs in triple-negative breast cancer [TNBC], non–small cell lung cancer [NSCLC], and other DNA damage repair [DDR]–deficient cancers, which can unlock significant value for patients and investors alike.”

Additionally, preliminary antitumor results revealed that disease control was achieved among 48% (n = 10/21) of patients following at least 2 cycles of LP-184 as of the data cutoff date of August 26, 2025. Furthermore, 25% (n = 4/16) of patients with glioblastoma multiforme (GBM) saw clinical benefit with the investigational agent following previous exposure to temozolomide (Temodar), lomustine, and/or radiation therapy.

Furthermore, among patients with CHK2, ATM, BRCA1 and STK11/KEAP1 mutations, including those with colon cancer, thymic carcinoma, gastrointestinal stromal tumors (GIST), and NSCLC, reductions in target cancer lesions were observed. One patient with NSCLC and DDR mutations achieved close to 2 years of clinical benefit and received ongoing treatment following progression on immunotherapy. Moreover, 2 patients who received 0.39 mg/kg, the recommended phase 2 dose (RP2D), sustained disease control after 6 months and were receiving ongoing treatment with LP-184.

The open-label, non-randomized study assessed LP-184 in 63 patients 18 years and older with advanced or metastatic solid tumors. A Bayesian Optimal Interval (BOIN) design was utilized, with patients receiving a dose determined on the available cohort at the time of enrollment.2 LP-184 was administered via infusion on days 1 and 8 of each 21-day cycle, for at least 2 cycles.

The primary end points included safety, tolerability, maximum tolerated dose, and RP2D of LP-184. Secondary end points included PK and preliminary clinical activity.

To be eligible for enrollment, patients must have had a histologically or cytologically confirmed advanced relapsed/refractory solid tumor for which no standard treatment is available; an ECOG performance status of 0 to 1 or Karnofsky performance scale of more than 60 for patients with GBM; a life expectancy of at least 3 months; and adequate liver, renal, bone marrow, and blood clotting function.

Developers are planning to advance multiple phase 1b/2 trials, with priority given to the use of LP-184:

• as a combination with olaparib (Lynparza) in patients with TNBC,
• with or without immunotherapy in patients with STK11/KEAP1-mutant NSCLC,
• and in DDR-altered bladder cancer as a monotherapy.

References

1. Lantern Pharma’s LP-184 phase 1a clinical trial achieves all primary endpoints with robust safety profile and promising antitumor activity in multiple advanced solid tumors. News release. Lantern Pharma. September 16, 2025. Accessed September 17, 2025. https://tinyurl.com/f65whzmt
2. Study of LP-184 in patients with advanced solid tumors. ClinicalTrials.gov. Updated March 6, 2025. Accessed September 16, 2025. https://tinyurl.com/ybv2ru6j