On September 16, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a leading artificial intelligence (AI)-driven oncology company leveraging its proprietary RADR platform to accelerate targeted cancer therapies, reported the successful completion of its Phase 1a clinical trial (NCT05933265) for LP-184 (Press release, Lantern Pharma, SEP 16, 2025, View Source [SID1234656004]). The trial met all primary endpoints, demonstrating a favorable safety and pharmacokinetic (PK) profile, and early signs of antitumor activity. Enrollment is complete, with several patients continuing treatment due to ongoing clinical benefit.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The open-label, multicenter, non-randomized study evaluated LP-184 in 63 patients with advanced relapsed or refractory solid tumors, including GBM. Primary objectives focused on safety, tolerability, PK, and determining a recommended Phase 2 dose (RP2D) when administered on Days 1 and 8 of a 21-day cycle.
Summary of Preliminary Phase 1a Safety and Pharmacokinetic Observations
LP-184 exhibited a robust safety profile, with no dose-limiting toxicities in the majority of cohorts and low incidence of discontinuations, interruptions, or delays due to drug-related adverse events. Adverse events were predominantly Grade 1 or 2, including manageable nausea and vomiting—consistent with alkylating agents—that resolved without significant intervention. The low rate of Grade 3+ events (minimal across the study) underscores LP-184’s tolerability, making it well-suited for potential monotherapy or combinations with agents like PARP inhibitors and immunotherapies, where preclinical synergies have been observed.
PK data confirmed that therapeutic concentrations were achieved at dose levels 8 (0.25 mg/kg) and above, aligning with preclinical models and supporting dose optimization for future trials. These observations will help further de-risk LP-184, enabling efficient advancement in biomarker-enriched populations identified via our RADR AI platform.
Summary of Preliminary Phase 1a Antitumor Observations
Promising antitumor activity emerged, particularly at dose levels 8 (0.25 mg/kg) and above, where therapeutic exposures were attained. Disease control was achieved in 48% (10/21) of evaluable patients after two cycles, including in heavily pre-treated cases. The median number of prior lines of therapy was 3; some patients had up to 8 prior lines of therapy.
Notable highlights from the overall study include:
Clinical benefit observed in 4 of 16 recurrent GBM patients previously exposed to temozolomide, lomustine, and/or radiation.
Marked reductions in target cancer lesions among patients with CHK2, ATM, BRCA1 and STK11/KEAP1 mutations, spanning colon cancer, thymic carcinoma, gastrointestinal stromal tumor (GIST), and NSCLC.
A NSCLC patient with DNA damage response (DDR) mutations, refractory to immunotherapy, achieved nearly two years of clinical benefit and remained on treatment.
Two patients at dose level 10 (0.39 mg/kg) maintain disease control beyond six months and continue on therapy.
These signals in DDR-deficient tumors further support LP-184’s synthetic lethal mechanism and highlight its potential in precision oncology.
"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," said Panna Sharma, Chief Executive Officer of Lantern Pharma. "Leveraging our RADR AI platform, we’re 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 TNBC, NSCLC, and other DDR-deficient cancers, which can unlock significant value for patients and investors alike."
Recommended Phase 2 Dose and LP-184 Future Development Plan
The Safety Review Committee supported an RP2D of 0.39 mg/kg in this regimen, with provisions for intra-patient escalation, based on the trial’s evaluation of safety, tolerability, and PK data. Building on these results, Lantern is developing plans to advance multiple Phase 1b/2 trials, prioritizing the following disease indications:
TNBC in combination with Olaparib (a PARP inhibitor), with potential for ctDNA as an early response biomarker to support accelerated approval pathways.
NSCLC with STK11/KEAP1 co-mutations, with or without immunotherapy.
Bladder cancer in a trial to be conducted as an investigator-led study in Denmark with patients harboring DNA damage repair genetic alterations.
These initiatives target high-value indications with substantial market potential and high clinical need.
Data Cutoff Date and Future Publications and Presentations
The data cutoff for the observations described in this release is August 26, 2025. Comprehensive results from the LP-184 Phase 1a trial are being prepared for peer-reviewed publications and presentations at upcoming oncology conferences.