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

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.

Conditions

KRAS P.G12C

Study Overview

Study Details

Study overview

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.

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

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

Condition
KRAS P.G12C
Intervention / Treatment

-

Contacts and Locations

Orange

D3 Bio Investigative Site, Orange, California, United States, 92868

Denver

D3 Bio Investigative Site, Denver, Colorado, United States, 80218-1238

Sarasota

D3 Bio Investigative Site, Sarasota, Florida, United States, 34232-6410

Detroit

D3 Bio Investigative Site, Detroit, Michigan, United States, 48202-2608

Nashville

D3 Bio Investigative Site, Nashville, Tennessee, United States, 37203

Houston

D3 Bio Investigative Site, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    D3 Bio (Wuxi) Co., Ltd,

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

    Study Record Dates

    2026-09