Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

Kartos Therapeutics

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: Navtemadlin; Drug: Navtemadlin Placebo

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT05797831

KRT-232-118

ENGOT en-21 (Other Identifier)

GOG-3089 (Other Identifier)

Details and patient eligibility

About

This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.

The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.

Enrollment: 268 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECOG 0-1
• Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
• Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1
• Adequate hematologic, hepatic and renal function (within 14 days)

Exclusion criteria

• Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation
• Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days)
• Indwelling surgical drains
• Grade 2 or higher QTc prolongation
• History of major organ transplant
• History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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268 participants in 7 patient groups, including a placebo group

Part 1 Arm 1

Experimental group

Description:

Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.

Treatment:

Drug: Navtemadlin

Part 1 Arm 2

Experimental group

Description:

Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.

Treatment:

Drug: Navtemadlin

Part 1 Arm 3

No Intervention group

Description:

Observational control ("watch and wait") on a 28-day cycle.

Part 2 Arm A

Experimental group

Description:

Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.

Treatment:

Drug: Navtemadlin

Part 2 Arm B

Experimental group

Description:

Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.

Treatment:

Drug: Navtemadlin

Part 2 Arm C

Placebo Comparator group

Description:

Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.

Treatment:

Drug: Navtemadlin Placebo

Part 2 Arm D

Placebo Comparator group

Description:

Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.

Treatment:

Drug: Navtemadlin Placebo