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

Recruiting Phase 1 Phase 2 Interventional Study
KRAS P.G12C
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
442 (estimated)
Sponsor
D3 Bio (Wuxi) Co., Ltd · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion: * Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing. * Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood. * Subject must have measurable…
Contacts

Medical Director

+86 21 61635900

D3bio_CT@d3bio.com

CONTACT