NCT04511845

Brief Summary

Phase I, open-label, multi-center study

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P75+ for phase_1

Timeline
5mo left

Started Sep 2020

Longer than P75 for phase_1

Geographic Reach
2 countries

15 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2020Sep 2026

First Submitted

Initial submission to the registry

July 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

6.1 years

First QC Date

July 8, 2020

Last Update Submit

July 10, 2025

Conditions

Locally Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (9)

  • Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation]

    Incidence and nature of DLTs

    From first dose until the end of Cycle 1 (approximately 35 days)

  • Safety and tolerability of SPYK04 (Adverse Events) [Dose escalation]

    Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0

    From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)

  • Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]

    Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval

    From first dose until the end of Cycle 1 (approximately 35 days)

  • Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]

    Heart Rate

    From first dose until the end of Cycle 1 (approximately 35 days)

  • Pharmacokinetics of SPYK04 [Dose escalation]

    Plasma concentrations of SPYK04

    From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)

  • Pharmacokinetics of SPYK04 [Dose escalation]

    Maximum plasma concentration (Cmax) of SPYK04

    From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)

  • Pharmacokinetics of SPYK04 [Dose escalation]

    Time to reach maximum plasma drug concentration (Tmax) of SPYK04

    From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)

  • Pharmacokinetics of SPYK04 [Dose escalation]

    Area under the concentration versus time curve (AUC) of SPYK04

    From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)

  • Preliminary anti-tumor activity of SPYK04 [Cohort expansion]

    Objective Response Rate (ORR) is defined as proportion of patients who had a confirmed complete response (CR) or partial response (PR), as determined by the investigator with use of 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, assessed up to 42 months (study completion)

Secondary Outcomes (10)

  • Preliminary anti-tumor activity of SPYK04 [Dose escalation]

    From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

  • Safety and tolerability of SPYK04 (AEs) [Cohort expansion]

    From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)

  • Preliminary anti-tumor activity of SPYK04 [Cohort expansion]

    From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

  • Preliminary anti-tumor activity of SPYK04 [Cohort expansion]

    From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

  • Preliminary anti-tumor activity of SPYK04 [Cohort expansion]

    From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

  • +5 more secondary outcomes

Study Arms (2)

Dose escalation cohort of SPYK04

EXPERIMENTAL

Patients will receive SPYK04 at escalated dose.

Drug: SPYK04

Expansion part in NSCLC, ovarian cancer and other solid tumors

EXPERIMENTAL

Patients will receive SPYK04 at the recommended dose.

Drug: SPYK04

Interventions

SPYK04DRUG

SPYK04 capsule

Dose escalation cohort of SPYK04Expansion part in NSCLC, ovarian cancer and other solid tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (Both Part I and Part II)
  • Age \>= 18 years at time of signing informed consent form
  • ECOG performance status of 0 or 1
  • Patients with a locally advanced, recurrent, or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable
  • (Part I only)
  • Patients with measurable and/or evaluable disease per RECIST v1.1
  • Patients with MAPK pathway alterations positive solid tumor (i.e., BRAF, K/N/H-RAS mutations)
  • (Part II only)
  • Patients with measurable disease per RECIST v1.1
  • Patients with KRAS mutated NSCLC (NSCLC cohort)
  • Patients with KRAS mutated Ovarian Cancer (Ovarian Cancer cohort)
  • Patients with RAS mutated solid tumor (Biopsy cohort)

You may not qualify if:

  • (Both Part I and Part II)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Arizona Oncology

Tucson, Arizona, 85711, United States

Location

Rocky Mountain Cancer Centers

Lone Tree, Colorado, 80124, United States

Location

Minnesota Oncology

Minneapolis, Minnesota, 55404, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Oncology

Tyler, Texas, 75702, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-Ku, Tokyo, 135-8550, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Osaka Prefectural Hospital Organization Osaka International Cancer Center

Osaka, 541-8567, Japan

Location

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

July 8, 2020

First Posted

August 13, 2020

Study Start

September 10, 2020

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).

Locations

US(9)JP(6)