RECRUITING

A Study of D3S 001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.

Official Title

A Phase 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S 001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Quick Facts

Study Start:2022-08-03
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05410145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Medical Director
CONTACT
+86 21 61635900
D3bio_CT@d3bio.com

Principal Investigator

Cheng Chen, MD
STUDY_DIRECTOR
D3 Bio (Wuxi) Co., Ltd

Study Locations (Sites)

D3 Bio Investigative Site
Orange, California, 92868
United States
D3 Bio Investigative Site
Denver, Colorado, 80218-1238
United States
D3 Bio Investigative Site
Sarasota, Florida, 34232-6410
United States
D3 Bio Investigative Site
Detroit, Michigan, 48202-2608
United States
D3 Bio Investigative Site
Nashville, Tennessee, 37203
United States
D3 Bio Investigative Site
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: D3 Bio (Wuxi) Co., Ltd

  • Cheng Chen, MD, STUDY_DIRECTOR, D3 Bio (Wuxi) Co., Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-03
Study Completion Date2026-09

Study Record Updates

Study Start Date2022-08-03
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • KRAS p.G12C
  • Mutation
  • advanced solid tumors

Additional Relevant MeSH Terms

  • KRAS P.G12C