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Protein Kinase Inhibitor
CX-4945 for Basal Cell Carcinoma
Phase 1
Waitlist Available
Research Sponsored by Senhwa Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1, twenty-eight (28) day continuous dosing schedule
Awards & highlights
Study Summary
This trial is to find the best dose of CX-4945 to give to patients with basal cell cancer that has spread, and to see if it is safe and effective.
Eligible Conditions
- Basal Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1, twenty-eight (28) day continuous dosing schedule
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1, twenty-eight (28) day continuous dosing schedule
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of RP2D
Secondary outcome measures
Absence of residual BCC in laBCC patients
Adverse Event
Objective response
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Expansion CX-4945 Metastatic BCCExperimental Treatment1 Intervention
CX-4945 capsules at 1000mg BID, on the dosing schedule identified during the Phase I treatment duration increment part of the study
Group II: Expansion CX-4945 Locally Advanced BCCExperimental Treatment1 Intervention
CX-4945 capsules at 1000mg BID, on the dosing schedule identified during the Phase I treatment duration increment part of the study
Group III: CX-4945 28 Day Dose DurationExperimental Treatment1 Intervention
CX-4945 capsules at 1000mg BID, on Days 1 through 28 of each treatment cycle
Group IV: CX-4945 21 Day Dose DurationExperimental Treatment1 Intervention
CX-4945 capsules at 1000mg BID, on Days 1 through 21 of each treatment cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CX-4945
2022
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
Senhwa Biosciences, Inc.Lead Sponsor
6 Previous Clinical Trials
417 Total Patients Enrolled
John Soong, MD, FCAPStudy DirectorSenhwa Biosciences
1 Previous Clinical Trials
52 Total Patients Enrolled
Jin-Ding Huang, PhDStudy DirectorSenhwa Biosciences
2 Previous Clinical Trials
188 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have trouble swallowing pills or other oral medications.You have long-term diarrhea, which means you have more bowel movements than usual.You are currently receiving any cancer treatment that is not part of the study protocol, such as chemotherapy, targeted therapy, radiation therapy, or photodynamic therapy.You have had another type of cancer within the past 3 years, except for certain types of cancers that are not likely to spread or cause harm. Examples of these types of cancers include treated skin cancer, early stage breast cancer, or early stage cervical cancer.
Research Study Groups:
This trial has the following groups:- Group 1: CX-4945 28 Day Dose Duration
- Group 2: CX-4945 21 Day Dose Duration
- Group 3: Expansion CX-4945 Locally Advanced BCC
- Group 4: Expansion CX-4945 Metastatic BCC
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.
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