KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer

Kartos Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Small-cell Lung Cancer; Small Cell Lung Cancer Recurrent; Small Cell Lung Carcinoma; Small Cell Lung Cancer Extensive Stage

Treatments: Drug: KRT-232

Study type: Interventional

Funder types: Industry

Identifiers

NCT05027867

KRT-232-112

Details and patient eligibility

About

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with relapsed or refractory small cell lung cancer.

This study will be conducted in 2 parts. Part 1 will evaluate two treatment arms, each with a different KRT-232 dose. Part 2 will continue the evaluation of the selected treatment arms from Part 1.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT
• Disease must be measurable per RECIST Version 1.1
• Evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse.
• Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.
• ECOG ≤ 2

Exclusion criteria

• Symptomatic or uncontrolled central nervous system (CNS) metastases.
• Prior treatment with MDM2 inhibitors
• Chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment
• Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
• History of major organ transplant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Arm 1

Experimental group

Description:

KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

Treatment:

Drug: KRT-232

Arm 2

Experimental group

Description:

KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

Treatment:

Drug: KRT-232