Study of LP-184 in Patients With Advanced Solid Tumors

Conditions

• Advanced Solid Tumor
• DDR Gene Mutation
• GBM
• Metastatic Solid Tumor
• NSCLC
• Pancreatic Adenocarcinoma
• TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LP-184 — DRUG
  LP-184 is a small molecule alkylating agent causing tumor cell death through DNA damage.
• Olaparib — DRUG
  A poly (ADP-ribose) polymerase (PARP) inhibitor that impairs homologous recombination (HR) dependent DNA damage repair by trapping PARP1/2 on DNA, leading to synthetic lethality in BRCA1/2-deficient cells.
• Nivolumab & Ipilimumab — DRUG
  Nivolumab is monoclonal antibody and classified as an immune checkpoint inhibitor. By blocking the PD-1 receptor on the surface of T cells, Nivolumab restores immune cells' ability to recognize and attack cancer cells. Ipilimumab is monoclonal antibody and classified as an immune checkpoint inhibitor. By blocking the CTLA4 protein on the surface of T cells, Ipilimumab activates T-cells and allows T-cells to attack cancer cells.

Study Details

The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available. The secondary objectives are to characterize the PK of LP-184 and its metabolites in plasma and assess clinical activity of LP-184. Participants will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, PK, and clinical activity

Key Dates

Start date

Jun 9, 2023

Status verified

Apr 2026

Primary completion

Jul 28, 2026

Completion

Jul 28, 2026

Study Design

Enrollment

64 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Master Protocol
  A phase 1/2 dose escalation and cohort expansion study of LP-184 in patients with advanced or metastatic solid tumors. A BOIN design will be used to evaluate the safety of LP-184, determine the MTD, and identify the RP2D. Patients who meet all eligibility criteria will be enrolled to receive treatment with LP-184 at a dose determined based on the available cohort at the time of each patient's enrollment. Patients will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles.
• Experimental: Supplement A
  Phase 1b/2 Expansion cohort of participants with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma (PDAC) or other solid tumours with known DDR genomic alterations to determine the optimal dose/RP2D and to obtain preliminary estimates of clinical activity.
• Experimental: Supplement C
  Phase 1b/2 Expansion cohort of participants with Hormone Receptor (HR)-Negative and HER2-Negative Breast Cancer (TNBC) to evaluate the safety, tolerability and clinical activity of LP-184 in combination with olaparib
• Experimental: Supplement D
  Phase 1b/2 Expansion cohort of participants with KEAP1 and/or STK11-mutated and programmed cell death ligand-1 (PD-L1)-low NSCLC to evaluate the safety, tolerability and clinical activity of LP-184 in combination with nivolumab and ipilimumab in .

Primary Outcome Measure

To evaluate the safety and tolerability of LP-184 assessed by the incidence and severity of all adverse events graded by CTCAE v5.0 [ Time Frame: 12 months ]

Locations (7)

Find similar trials in Springdale, AR

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