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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
RET-altered Solid Tumors Drug: APS03118 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 6, 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: APS03118 Dose Escalation
APS03118 administered orally
 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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of DLTs during Cycle 1 in dose-escalation cohorts [ Time Frame: Within the 28 days of the first APS03118 dose for each patient ]
  2. 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)


Secondary Outcome Measures :
  1. Adverse events(AE) [ Time Frame: Approximately 24 months ]
  2. Peak Plasma Concentration (Cmax) [ Time Frame: Up to approximately 1 month ]
  3. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to approximately 1 month ]
  4. Time to Maximum Concentration (Tmax) [ Time Frame: Up to approximately 1 month ]
  5. Degree of accumulation [ Time Frame: Up to approximately 1 month ]
  6. 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)

  7. Duration of response (DOR) [ Time Frame: Up to approximately 24 months ]
  8. Best of response (BOR) [ Time Frame: Up to approximately 24 months ]
  9. Disease Control Rate (DCR) [ Time Frame: Up to approximately 24 months ]
  10. Progress Free Survival (PFS) [ Time Frame: Up to approximately 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05653869


Contacts
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Contact: Jun Zhong, PhD +86 13820403158 zhongjun@apspharm.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Shun Lu, MD, PhD         
Sponsors and Collaborators
Applied Pharmaceutical Science, Inc.
More Information
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Responsible Party: Applied Pharmaceutical Science, Inc.
ClinicalTrials.gov Identifier: NCT05653869    
Other Study ID Numbers: APS-RET-102
First Posted: December 16, 2022    Key Record Dates
Last Update Posted: June 15, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms