Clincosm LogoSign in Get a demo

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

Sponsor
D3 Bio (Wuxi) Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05410145
Collaborator
(none)
98
Enrollment
13
Locations
1
Arm
32.9
Anticipated Duration (Months)
7.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
Actual Study Start Date :
Aug 3, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: D3S-001

Dose Escalation, D3S-001 administered orally. Dose Expansion, D3S-001 administered orally in selected cancer type patients.

Drug: D3S-001
Oral

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Adverse Events (AEs) [From first dose until 30 days after the last dose (or specified in the protocol).]

  2. Number of Participants With Dose-Limiting Toxicities (DLTs) [From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.]

Secondary Outcome Measures

  1. D3S-001 maximum observed plasma concentration (Cmax) [Up to 24 months.]

  2. D3S-001 time to maximum plasma concentration (tmax) [Up to 24 months.]

  3. D3S-001 half-life (t1/2) [Up to 24 months.]

  4. D3S-001 area under the concentration-time curve (AUC) [Up to 24 months.]

  5. Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Up to 24 months.]

  6. Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Up to 24 months.]

  7. Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Up to 24 months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 disease per RECIST v1.1.

  • Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or

  • Subject must have adequate organ and marrow function within the screening period.
Exclusion:

  • Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.

  • Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.

  • Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).

  • Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.

  • Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).

Contacts and Locations

Locations

Site City State Country Postal Code
1 D3 Bio Investigative Site Detroit Michigan United States 48202-2608
2 D3 Bio Investigative Site Sydney New South Wales Australia 2109
3 D3 Bio Investigative Site Malvern Victoria Australia 3144
4 D3 Bio Investigative Site Beijing Beijing China 100036
5 D3 Bio Investigative Site Guangzhou Guangzhou China 510120
6 D3 Bio Investigative Site Hangzhou Hangzhou China 310022
7 D3 Bio Investigative Site Nanchang Jiangxi China 330008
8 D3 Bio Investigative Site Shenyang Liaoning China 110042
9 D3 Bio Investigative Site Shanghai Shanghai China 200030
10 D3 Bio Investigative Site Sha Tin Hong Kong 999077
11 D3 Bio Investigative Site Seoul Korea, Republic of 06591
12 D3 Bio Investigative Site Seoul Korea, Republic of 120-752
13 D3 Bio Investigative Site Seoul Korea, Republic of 138-736

Sponsors and Collaborators

  • D3 Bio (Wuxi) Co., Ltd

Investigators

  • Study Director: Cheng Chen, MD, D3 Bio (Wuxi) Co., Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
D3 Bio (Wuxi) Co., Ltd
ClinicalTrials.gov Identifier:
NCT05410145
Other Study ID Numbers:
  • D3S-001-100
First Posted:
Jun 8, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by D3 Bio (Wuxi) Co., Ltd
KRAS p.G12C
Mutation
advanced solid tumors

Study Results

No Results Posted as of Aug 5, 2022