Spots Global Cancer Trial Database for A Study of D3S 001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
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Trial Identification
Brief Title: A Study of D3S 001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
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
Study ID: NCT05410145
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
D3 Bio Investigative Site, Orange, California, United States
D3 Bio Investigative Site, Denver, Colorado, United States
D3 Bio Investigative Site, Detroit, Michigan, United States
D3 Bio Investigative Site, Houston, Texas, United States
D3 Bio Investigative Site, Sydney, New South Wales, Australia
D3 Bio Investigative Site, Malvern, Victoria, Australia
D3 Bio Investigative Site, Nedlands, Western Australia, Australia
D3 Bio Investigative Site, Beijing, Beijing, China
D3 Bio Investigative Site, Guangzhou, Guangdong, China
D3 Bio Investigative Site, Hangzhou, Hangzhou, China
D3 Bio Investigative Site, Harbin, Heilongjiang, China
D3 Bio Investigative Site, Wuhan, Hubei, China
D3 Bio Investigative Site, Wuhan, Hubei, China
D3 Bio Investigative Site, Nanchang, Jiangxi, China
D3 Bio Investigative Site, Shenyang, Liaoning, China
D3 Bio Investigative Site, Shanghai, Shanghai, China
D3 Bio Investigative Site, Shanghai, Shanghai, China
D3 Bio Investigative Site, Sha Tin, , Hong Kong
D3 Bio Investigative Site, Cheongju-si, North Chungcheong, Korea, Republic of
D3 Bio Investigative Site, Seoul, , Korea, Republic of
D3 Bio Investigative Site, Seoul, , Korea, Republic of
D3 Bio Investigative Site, Seoul, , Korea, Republic of
Contact Details
Name: Cheng Chen, MD
Affiliation: D3 Bio (Wuxi) Co., Ltd
Role: STUDY_DIRECTOR
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