The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or Fusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05653869
Recruitment Status : Recruiting
First Posted : December 16, 2022
Last Update Posted : June 15, 2023
Sponsor:
Information provided by (Responsible Party):
Applied Pharmaceutical Science, Inc.

Tracking Information
First Submitted Date  ICMJE November 15, 2022
First Posted Date  ICMJE December 16, 2022
Last Update Posted Date June 15, 2023
Actual Study Start Date  ICMJE February 6, 2023
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2022)
  • Incidence of DLTs during Cycle 1 in dose-escalation cohorts [ Time Frame: Within the 28 days of the first APS03118 dose for each patient ]
  • The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D) [ Time Frame: Approximately 15 months ]
    The MTD is defined as the maximum dose at which the incidence of dose-limiting toxicities (DLTs) during Cycle 1 is below 30%(<2/6)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2022)
  • Adverse events(AE) [ Time Frame: Approximately 24 months ]
  • Peak Plasma Concentration (Cmax) [ Time Frame: Up to approximately 1 month ]
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to approximately 1 month ]
  • Time to Maximum Concentration (Tmax) [ Time Frame: Up to approximately 1 month ]
  • Degree of accumulation [ Time Frame: Up to approximately 1 month ]
  • Overall Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]
    As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Duration of response (DOR) [ Time Frame: Up to approximately 24 months ]
  • Best of response (BOR) [ Time Frame: Up to approximately 24 months ]
  • Disease Control Rate (DCR) [ Time Frame: Up to approximately 24 months ]
  • Progress Free Survival (PFS) [ Time Frame: Up to approximately 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or Fusions
Official Title  ICMJE A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APS03118 in Adult Patients With Unresectable Locally Advanced or Metastatic Solid Tumors Harboring RET Mutations or Fusions
Brief Summary This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of APS03118 administered orally in participants with RET-altered solid tumors.
Detailed Description After being informed about the study procedure and potential risks and benefits, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. The eligible participants will be enrolled using a rolling 6 dose escalation scheme to identify MTD and/or RP2D.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE RET-altered Solid Tumors
Intervention  ICMJE Drug: APS03118
Participant received APS03118 orally until evidence of unacceptable toxicity, progressed disease, consent withdrawal or with drawl from the study at the discretion of the investigator.
Other Name: APS03118 administrated orally
Study Arms  ICMJE Experimental: APS03118 Dose Escalation
APS03118 administered orally
Intervention: Drug: APS03118
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2022)		 35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2025
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients aged 18 years or older
  2. Have histological or cytological confirmation of unresectable locally advanced or metastatic solid tumors harboring oncogenic RET mutations or fusions confirmed by NGS. Site may identify patients with a RET-mutated or RET-fusion solid tumor before the formal screening.
  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  4. Resolution of all toxic effects of prior therapies to Grade 1 or below according to NCI CTCAE version 5.0 (except alopecia or Grade 2 neuropathy);
  5. Patients with asymptomatic brain metastases if they have been previously treated, demonstrated no progression at least for 1 months before Screening, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening
  6. Adequate organ function

Exclusion Criteria:

  1. Have a locally advanced solid tumor that is a candidate for curative surgery treatment through radical surgery and/or radiotherapy.
  2. Have an active fungal, bacterial, and/or active untreated viral infection
  3. The patient has a serious pre-existing medical condition(s)
  4. Have received or will receive a COVID-19 vaccine within 1 month before the first dose of APS03118.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jun Zhong, PhD +86 13820403158 zhongjun@apspharm.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05653869
Other Study ID Numbers  ICMJE APS-RET-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Applied Pharmaceutical Science, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Applied Pharmaceutical Science, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Applied Pharmaceutical Science, Inc.
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP