D3S-001 for KRAS P.G12C

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
D3 Bio Investigative Site, Nanchang, China
KRAS P.G12C
D3S-001 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This first-in-human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of D3S-001 and identify the recommended Phase 2 dose (RP2D) when D3S-001 is administered as monotherapy to subjects with advanced solid tumors with the Kirsten rat sarcoma viral oncogene homolog gene (KRAS) p.G12C mutation.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for KRAS P.G12C

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Up to 24 months.

Day 21
Number of Participants With Dose-Limiting Toxicities (DLTs)
Day 30
Number of Participants With Adverse Events (AEs)
Up to 24 months.
D3S-001 area under the concentration-time curve (AUC)
D3S-001 half-life (t1/2)
D3S-001 maximum observed plasma concentration (Cmax)
D3S-001 time to maximum plasma concentration (tmax)
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Trial Safety

Safety Progress

1 of 3

Other trials for KRAS P.G12C

Trial Design

1 Treatment Group

D3S-001
1 of 1
Experimental Treatment

98 Total Participants · 1 Treatment Group

Primary Treatment: D3S-001 · No Placebo Group · Phase 1

D3S-001
Drug
Experimental Group · 1 Intervention: D3S-001 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months.
Closest Location: D3 Bio Investigative Site · San Francisco, CA
Photo of San Francisco 1Photo of San Francisco 2Photo of San Francisco 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching KRAS P.G12C
0 CompletedClinical Trials

Who is running the clinical trial?

D3 Bio (Wuxi) Co., LtdLead Sponsor
Cheng Chen, MDStudy DirectorD3 Bio (Wuxi) Co., Ltd

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a performance status of 0 or 1.
You have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
You have previously received treatment with NCI CTCAE Grade ≥2 anticancer therapy.
Subjects have had prior treatment with other treatments without adequate washout periods as defined in the protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.