A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).

Chugai Pharmaceutical

Status and phase: Active, not recruiting; Phase 1

Conditions: Locally Advanced or Metastatic Solid Tumors

Treatments: Drug: LUNA18; Drug: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05012618

LUN101JG

Details and patient eligibility

About

This is a Phase 1 dose-escalation and cohort expansion study that will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of LUNA18 when administered as a single agent or in combination with other anti-cancer drugs in patients with locally advanced or metastatic solid tumors.

Enrollment: 195 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >= 18 years at time of signing informed consent form
• ECOG performance status of 0 or 1
• Patients with a histologically or cytologically proven diagnosis of a locally advanced, recurrent, or metastatic incurable solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable
• Patients with documented RAS alterations positive solid tumors
• Patients with measurable disease per RECIST v1.1

Exclusion criteria

• Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), unstable angina, or myocardial infarction within the previous 6 months or unstable arrhythmias within the previous 3 months
• Patients with primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
• Patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection)
• Patients with a history or complication of interstitial lung disease (ILD)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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195 participants in 6 patient groups

Dose escalation part (Part A)

Experimental group

Description:

Patients will receive LUNA18 capsule(s) at escalated doses

Treatment:

Drug: LUNA18

Biomarker part (Part B)

Experimental group

Description:

Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A

Treatment:

Drug: LUNA18

Cohort expansion part (Part C)

Experimental group

Description:

Patients will receive LUNA18 capsule(s) at the recommended dose

Treatment:

Drug: LUNA18

Backfill part (Part AA)

Experimental group

Description:

Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A

Treatment:

Drug: LUNA18

Dose finding part (Part D)

Experimental group

Description:

Patients will receive LUNA18 capsule(s) in combination with cetuximab at finding doses

Treatment:

Drug: Cetuximab

Drug: LUNA18

Cohort expansion part (Part E)

Experimental group

Description:

Patients will receive LUNA18 capsule(s) in combination with cetuximab at the recommended dose

Treatment:

Drug: Cetuximab

Drug: LUNA18