Your session is about to expire
← Back to Search
Antibody-drug conjugate
TROP2 ADC for Cancer (A264 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Klus Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 1 to cycle 6 and end of treatment(eot), approximately 12 months
Awards & highlights
A264 Trial Summary
This trial is for patients with cancer that has not responded to available treatments and who have no other options.
Who is the study for?
Adults aged 18-75 with advanced solid tumors that can't be surgically removed or have spread and don't respond to standard treatments. Specific cancers include certain types of breast, ovarian, lung, gastric, head and neck, endometrial, and urothelial cancers. Participants must have acceptable organ function and blood counts, not require oxygen for daily activities or have severe heart conditions.Check my eligibility
What is being tested?
SKB264 is being tested in this Phase I-II trial on patients with various advanced solid tumors unresponsive to standard therapies. The study aims to evaluate the safety and effectiveness of SKB264 as a potential treatment option for these patients.See study design
What are the potential side effects?
Potential side effects are not specified here but generally could include reactions at the infusion site, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, liver issues like elevated enzymes or bilirubin levels indicating liver stress.
A264 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My kidneys work well enough to clear waste from my blood.
Select...
My cancer is advanced, cannot be cured, and started in the lining of organs.
Select...
I am between 18 and 75 years old.
A264 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from cycle 1 to cycle 6 and end of treatment(eot), approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 1 to cycle 6 and end of treatment(eot), approximately 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)
Phase II: Objective Response Rate (ORR)
Secondary outcome measures
Phase I: Dose Limiting Toxicities (DLTs)
Phase I: Overall safety and tolerability profile
Phase I: PK parameters for SKB264-ADC, SKB264 TAB, and free KL610023 payload.
+12 moreA264 Trial Design
11Treatment groups
Experimental Treatment
Group I: Phase II:EGFR wild-type NSCLCExperimental Treatment1 Intervention
Histologically or cytologically documented, incurable, locally advanced or metastatic cancer
Group II: Phase II: Urothelial carcinomaExperimental Treatment1 Intervention
Histologically or cytologically documented, incurable, locally advanced or metastatic cancer
Group III: Phase II: Triple Negative Breast cancerExperimental Treatment1 Intervention
Histologically documented or cytologically , incurable, locally advanced or metastatic cancer
Group IV: Phase II: Non-Small Cell Lung CancerExperimental Treatment1 Intervention
Histologically documented or cytologically, incurable, locally advanced or metastatic cancer
Group V: Phase II: Head and neck squamous cell carcinomaExperimental Treatment1 Intervention
Histologically documented or cytologically , incurable, locally advanced or metastatic cancer
Group VI: Phase II: HR+/ HER2- breast cancerExperimental Treatment1 Intervention
Histologically documented or cytologically, incurable, locally advanced or metastatic cancer
Group VII: Phase II: Gastric Adenocarcinoma or gastroesophageal junction adenocarcinomaExperimental Treatment1 Intervention
Histologically or cytologically documented, incurable, locally advanced or metastatic cancer
Group VIII: Phase II: Extensive-stage small Cell Lung CancerExperimental Treatment1 Intervention
Histologically documented or cytologically, incurable, locally advanced or metastatic cancer
Group IX: Phase II: Epithelial ovarian cancerExperimental Treatment1 Intervention
Histologically documented or cytologically , incurable, locally advanced or metastatic cancer
Group X: Phase II: Endometrial carcinomaExperimental Treatment1 Intervention
Histologically documented or cytologically , incurable, locally advanced or metastatic cancer
Group XI: Phase I: Dose EscalationExperimental Treatment1 Intervention
Five dose levels have been selected for evaluation in the Phase I part of the study: 2, 4, 6, 9, and 12 mg/kg of SKB264
Find a Location
Who is running the clinical trial?
Klus Pharma Inc.Lead Sponsor
3 Previous Clinical Trials
529 Total Patients Enrolled
Jordi Rodon Ahnert, MD, PhDStudy ChairM.D. Anderson Cancer Center
2 Previous Clinical Trials
153 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs within the last 4 weeks.I have been treated with TROP 2 targeted therapies before.I have had recent brain surgery or radiation, or I have symptoms from brain cancer.I haven't taken strong CYP3A4 inhibitors or inducers for 14 days.I have had a new blood clot that needed treatment in the past 6 months.I have a serious heart condition that needs treatment.I haven't had cancer treatment in the last 4 weeks or before the study drug's half-life period.Your white blood cell count, platelet count, and hemoglobin levels are within a certain range.Your heart's pumping ability is too low based on a special heart test.I need extra oxygen to do my daily activities.You have previously tested positive for HIV or have a history of HIV.I am fully active or can carry out light work.I haven't had major surgery in the last 4 weeks.I have recovered from side effects of my previous treatments, except for hair loss or skin color loss.I have high blood pressure or diabetes that is not well-managed.Your blood clotting tests are within a normal range.I have severe eye conditions like dry eye, Meibomian gland disease, or macular degeneration.My liver function tests are within the required range.My kidneys work well enough to clear waste from my blood.I agree to use effective birth control during the study.I have no other cancers except treated skin or cervical cancer without relapse in 3 years.Your heart's electrical activity is too high when you're at rest.My cancer is advanced, cannot be cured, and started in the lining of organs.I am between 18 and 75 years old.I have fluid buildup in my chest causing symptoms.Your disease can be measured by a CT or MRI scan.You are expected to live for at least 3 more months.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have had lung conditions that needed steroids or caused severe breathing problems.My cancer cannot be removed by surgery and does not respond to standard treatments.I have or had liver disease, including hepatitis, alcoholism, or cirrhosis.I need a procedure to remove excess fluid from my abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II: Non-Small Cell Lung Cancer
- Group 2: Phase I: Dose Escalation
- Group 3: Phase II: Triple Negative Breast cancer
- Group 4: Phase II: Epithelial ovarian cancer
- Group 5: Phase II: Gastric Adenocarcinoma or gastroesophageal junction adenocarcinoma
- Group 6: Phase II: Extensive-stage small Cell Lung Cancer
- Group 7: Phase II: HR+/ HER2- breast cancer
- Group 8: Phase II: Head and neck squamous cell carcinoma
- Group 9: Phase II: Endometrial carcinoma
- Group 10: Phase II: Urothelial carcinoma
- Group 11: Phase II:EGFR wild-type NSCLC
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.
Who meets the qualifications for enrollment in this clinical exploration?
"This study is open to 250 individuals aged between 18 and 75 who have been diagnosed with breast cancer. Additionally, male or female patients suffering from small cell lung cancer or urothelial cancers may be eligible. Verifying TROP2 expression by immunohistology is not necessary; however, the Sponsor will request tissue specimens for this purpose."
Answered by AI
What is the current participation rate for this research endeavor?
"Affirmative. Reports on clinicaltrials.gov assert that this medical experiment, first advertised February 28th 2020, is still recruiting participants. 250 individuals will be accepted at 6 distinct locations."
Answered by AI
Does this experiment accept test subjects of advanced age?
"This investigation is open to all participants aged 18 and over, but no more than 75 years old."
Answered by AI
Is this investigation recruiting newly enrolled participants?
"Affirmative. According to information on clinicaltrials.gov, this medical trial is currently seeking participants and was first published on February 28th 2020 with last update occurring July 11th 2022. The study requires 250 individuals between 6 different sites for completion."
Answered by AI
What is the ultimate purpose of this research?
"This clinical trial, which is set to evaluate results in a 12-month period, aims to measure the Objective Response Rate (ORR) of SKB264. Secondary objectives include an assessment of overall safety and tolerability profile by severity and dosage; preliminary efficacy as determined by ORR according to RECIST Version 1.1 criteria including complete response (CR) + partial response (PR); and evaluation of DOR(Duration of Response)."
Answered by AI
How widely distributed is this research endeavor?
"This trial is actively enrolling at START MidWest in Grand Rapids, Michigan; Florida Cancer Specialists and Research Institute in Sarasota, Florida; Providence Cancer Institute's Franz Clinic in Portland, Oregon and 6 other medical centres."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger