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

NCT05012618 | Terminated Phase 1 FDA Drug

• 1 other identifier: LUN101JG
• Study Type: interventional
• Target: 128
• Locations: 2 countries
• Sites: 20

Brief Summary

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.

Conditions

Locally Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (8)

• Safety and tolerability of LUNA18 (Dose-limiting toxicities) when administered as a single agent [Part A] and in combination with other anti-cancer drugs [Part D]

  Incidence and nature of dose-limiting toxicities (DLTs)

  From Cycle 0 Day 1 until Cycle 1 Day 28 (Cycle 0 is 6-9 days, and Cycle 1 is 28 days)

• Safety and tolerability of LUNA18 (Adverse Events) [Part A, AA, B, C, D and E]

  Incidence, nature and severity of adverse events, with severity determined per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)

  From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)

• Plasma concentrations of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]

  Plasma concentrations of LUNA18

  From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)

• Maximum plasma concentration (Cmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]

  Maximum plasma concentration (Cmax) of LUNA18

  From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)

• Time to reach maximum plasma drug concentration (Tmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]

  Time to reach maximum plasma drug concentration (Tmax) of LUNA18

  From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)

• Area under the concentration versus time curve (AUC) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]

  Area under the concentration versus time curve (AUC) of LUNA18

  From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)

• Phosphorylation level of ERK protein (pERK) in tumor tissues [Part B]

  Phosphorylation level of ERK protein (pERK) in tumor tissues biomarkers as applicable in tumor tissues

  From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible

• Preliminary anti-tumor activity of LUNA18 when administered as a single agent [Part B, C] and in combination with other anti-cancer drugs [Part E]

  Objective response, defined as a confirmed complete response (CR) or partial response (PR) as best overall response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)

Secondary Outcomes (7)

• Preliminary anti-tumor activity of LUNA18 when administered as a single agent [Part A, Part AA] and in combination with other anti-cancer drugs [Part D]

  From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)

• Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]

  From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)

• Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]

  From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)

• Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]

  From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)

• Anti-drug antibody to LUNA18[Part A, AA, B, C, D and E]

  From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)

Study Arms (6)

Dose escalation part (Part A)

EXPERIMENTAL

Patients will receive LUNA18 capsule(s) at escalated doses

Drug: LUNA18

Biomarker part (Part B)

EXPERIMENTAL

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

Drug: LUNA18

Cohort expansion part (Part C)

EXPERIMENTAL

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

Drug: LUNA18

Backfill part (Part AA)

EXPERIMENTAL

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

Drug: LUNA18

Dose finding part (Part D)

EXPERIMENTAL

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

Drug: LUNA18; Drug: Cetuximab

Cohort expansion part (Part E)

EXPERIMENTAL

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

Drug: LUNA18; Drug: Cetuximab

Interventions

LUNA18 DRUG

LUNA18 Capsule

Backfill part (Part AA); Biomarker part (Part B); Cohort expansion part (Part C); Cohort expansion part (Part E); Dose escalation part (Part A); Dose finding part (Part D)

Cetuximab DRUG

Cetuximab as a IV infusion

Cohort expansion part (Part E); Dose finding part (Part D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (20)

University of California - Davis

Davis, California, 95616, United States

Location

Beth Israel Deaconess

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, 49546, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Abramson Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Rhode Island Hospital-Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

NEXT Oncology

Austin, Texas, 78758, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Shizuoka Cancer Center

Nakatogari, Shizuoka, 411-0934, Japan

Location

National Cancer Center Hospital

Chuo-Ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sponsor Chugai Pharmaceutical Co. Ltd

  clinical-trials@chugai-pharm.co.jp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 19, 2021
• Study Start: October 8, 2021
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

JP (7); US (13)