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Study of D3S-002 as Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

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ClinicalTrials.gov Identifier: NCT05886920
Recruitment Status : Recruiting
First Posted : June 2, 2023
Last Update Posted : August 31, 2023
Sponsor:
Information provided by (Responsible Party):
D3 Bio (Wuxi) Co., Ltd

Study Description
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Brief Summary:
This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors With MAPK Pathway Mutations Drug: D3S-002 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations
Actual Study Start Date : July 10, 2023
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: D3S-002
Dose Escalation, D3S-002 administered orally.
 Drug: D3S-002
Oral


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: First dose until 30 days after the last dose (or specified in the protocol) ]
  2. Number of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days. ]

Secondary Outcome Measures :
  1. D3S-002 maximum observed plasma concentration (Cmax) [ Time Frame: First dose up to 24 months ]
  2. D3S-002 time to maximum plasma concentration (tmax) [ Time Frame: First dose up to 24 months ]
  3. D3S-002 half-life (t1/2) [ Time Frame: First dose up to 24 months ]
  4. D3S-002 area under the concentration-time curve (AUC) [ Time Frame: First dose up to 24 months ]
  5. Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: Until disease progression or end of treatment (up to approximately 24 months) ]
  6. Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: Until disease progression or end of treatment (up to approximately 24 months) ]
  7. Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: Until disease progression or end of treatment (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:

  • Subjects must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor with evidence of progressive disease.
  • Subjects must have documented mitogen-activated protein kinase (MAPK) pathway mutation(s) within the last 5 years identified by a local test on tumor tissue or blood (eg, rat sarcoma (RAS), rapidly accelerated fibrosarcoma (RAF), and MAPK kinase (MAPKK) mutations).
  • Subjects must be refractory to or intolerable with standard treatment, or have no available standard of care.
  • Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Subject must have adequate organ and marrow function within the screening period.

Exclusion:

  • Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
  • Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
  • Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
  • Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
  • Any concurrent chemotherapy, immunotherapy, targeted therapy, cell therapy, biologic or hormonal therapy and any medical devices for cancer treatment.
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): NCT05886920


Contacts
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Contact: Medical Director +86 21 61635900 D3bio_CT@d3bio.com

Locations
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Australia, New South Wales
D3 Bio Investigative Site Recruiting
Blacktown, New South Wales, Australia, 2148
Australia, South Australia
D3 Bio Investigative Site Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Western Australia
D3 Bio Investigative Site Recruiting
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
D3 Bio (Wuxi) Co., Ltd
More Information
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Responsible Party: D3 Bio (Wuxi) Co., Ltd
ClinicalTrials.gov Identifier: NCT05886920    
Other Study ID Numbers: D3S-002-100
First Posted: June 2, 2023    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by D3 Bio (Wuxi) Co., Ltd:
Advanced solid tumors
mitogen-activated protein kinase
mutation
Additional relevant MeSH terms:
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Neoplasms