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Small Molecule
D3S-001 for KRAS Mutation-related Cancer
Phase 1 & 2
Recruiting
Research Sponsored by D3 Bio (Wuxi) Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months.
Awards & highlights
Study Summary
This trial will test a new drug, D3S-001, on people with advanced solid tumors that have a specific KRAS gene mutation. The goal is to find out if the drug is safe and works well against the cancer.
Who is the study for?
This trial is for adults with advanced solid tumors that have a specific genetic change called KRAS p.G12C mutation. They must show measurable disease progression, be relatively fit (ECOG status of 0 or 1), and have good organ and marrow function. People can't join if they're still experiencing significant side effects from previous cancer treatments, are in other treatment studies, haven't waited long enough after past treatments, or have illnesses that could affect the study drug's action or their participation.Check my eligibility
What is being tested?
The trial is testing D3S-001 as a solo treatment to see how safe it is and how well people tolerate it. It will also look at how the body processes the drug and its effect on tumors in patients with advanced solid tumors carrying the KRAS p.G12C mutation. The goal is to find out the best dose for Phase 2 trials.See study design
What are the potential side effects?
Since this is a first-in-human study for D3S-001, potential side effects aren't fully known yet but may include typical reactions seen with cancer drugs such as nausea, fatigue, blood count changes, liver enzyme elevations, and possibly others based on how it affects tumor cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is spreading and has been confirmed by a lab test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Adverse Events (AEs)
Number of Participants With Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
D3S-001 area under the concentration-time curve (AUC)
D3S-001 half-life (t1/2)
D3S-001 maximum observed plasma concentration (Cmax)
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: D3S-001 monotherapyExperimental Treatment1 Intervention
Part 1: Dose Escalation, D3S-001 administered orally.
Part 2 and Part 3a Arm C: Dose Expansion, D3S-001 administered orally in selected cancer type patients.
Group II: D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + permetrexed)Experimental Treatment4 Interventions
Part 3a Arm B: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.
Cisplatin + pemetrexed administered intravenously
or
Carboplatin + permetrexed administered intravenously
Group III: D3S-001 and pembrolizumabExperimental Treatment2 Interventions
Part 3a Arm A: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.
Pembrolizumab administered intravenously.
Group IV: D3S-001 and CetuximabExperimental Treatment2 Interventions
Part 3b: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.
Cetuximab administered intravenously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cetuximab
2011
Completed Phase 3
~2480
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
D3 Bio (Wuxi) Co., LtdLead Sponsor
2 Previous Clinical Trials
170 Total Patients Enrolled
Cheng Chen, MDStudy DirectorD3 Bio (Wuxi) Co., Ltd
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently in a study that involves new drug treatments, radiotherapy, or surgery.I do not have stomach or bowel problems that could affect how medicine works in my body.I do not have any serious illnesses or conditions that would stop me from following the study rules.I have not had recent treatments without following the required break period.My cancer has a KRAS mutation identified in the last 5 years.I don't have serious side effects from cancer treatment, except for hair loss or skin color changes.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is spreading and has been confirmed by a lab test.My organs and bone marrow are working well.
Research Study Groups:
This trial has the following groups:- Group 1: D3S-001 monotherapy
- Group 2: D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + permetrexed)
- Group 3: D3S-001 and pembrolizumab
- Group 4: D3S-001 and Cetuximab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are slots available for individuals who wish to participate in this clinical trial?
"Affirmative. Information hosted on clinicaltrials.gov confirms that this research endeavour, initially posted on August 3rd 2022, is actively recruiting for 98 participants at two separate study sites."
Answered by AI
How many participants are being enlisted in this experiment?
"Affirmative. The clinical trial details hosted on clinicaltrials.gov reveal that the study is actively recruiting; it was initially listed on August 3rd 2022 and last updated on November 21st 2022, with a goal of finding 98 participants from 2 different medical centres."
Answered by AI
What potential health hazards does D3S-001 pose for individuals?
"Our team at Power has determined that the safety of D3S-001 is a 1, as this study is in its initial phase with limited data on both efficacy and safety."
Answered by AI
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