TROP2 ADC for Cancer
(MK-2870-001 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, SKB264 (also known as MK-2870), for individuals with advanced cancers unresponsive to standard therapies. It includes various solid tumors, such as breast, ovarian, and lung cancer. The study divides into parts, each targeting a specific cancer type to evaluate the treatment's effectiveness and potential side effects. Ideal candidates have advanced cancer that cannot be surgically removed and have not benefited from other treatments. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive it.
Will I have to stop taking my current medications?
The trial requires that you stop any standard cancer therapy or experimental therapy at least 4 weeks or five half-lives before starting the study drug. Additionally, you cannot use strong inhibitors or inducers of CYP3A4 at least 14 days prior to and throughout the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that SKB264, a treatment tested for various advanced cancers, generally has a manageable safety profile according to multiple studies. For patients with triple-negative breast cancer, studies found that SKB264 was well-tolerated, with no unexpected safety issues. In non-small cell lung cancer, the treatment was manageable, with few serious side effects. Similarly, for endometrial and ovarian cancers, SKB264 was well-tolerated, showing a favorable safety profile.
In gastric or gastroesophageal junction adenocarcinoma, SKB264 was linked to some side effects, but these were generally manageable. Studies on head and neck squamous cell carcinoma and cervical cancer also indicate that SKB264's safety is manageable, with the treatment usually not causing severe side effects.
These findings come from earlier clinical studies, meaning SKB264 has been tested in humans but is still under study to fully understand its safety and effectiveness.12345Why do researchers think this study treatment might be promising?
Researchers are excited about SKB264 because it represents a new approach in targeting cancers that express the TROP2 protein, which is common in many aggressive tumors. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, SKB264 is an antibody-drug conjugate (ADC) that specifically targets cancer cells, potentially leading to fewer side effects. This precision targeting allows the drug to deliver a potent chemotherapy agent directly to the cancer cells. This targeted approach could offer improved effectiveness and safety over existing treatments, making it a promising option for patients with difficult-to-treat cancers.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that SKB264, the investigational treatment in this trial, yields promising results in treating several advanced cancers. Participants with triple-negative breast cancer may experience lasting improvements and a trend toward longer survival. For those with epithelial ovarian cancer, 45% of patients responded to the treatment, with some showing significant progress. Early results for gastric adenocarcinoma suggest lasting benefits and the possibility of longer survival. Participants with non-small cell lung cancer may find SKB264 effective, with 34% of patients responding and experiencing several months before disease progression. These findings support the potential effectiveness of SKB264 in treating various challenging cancer types.12567
Who Is on the Research Team?
Jordi Rodon Ahnert, MD, PhD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I: Dose Escalation
Participants receive SKB264 as a single IV infusion at escalating dose levels to determine the maximum tolerated dose (MTD) and recommended doses for expansion (RDEs).
Phase II: Treatment
Participants receive SKB264 at the recommended dose levels for expansion to evaluate the objective response rate (ORR) and other efficacy measures.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and overall survival.
What Are the Treatments Tested in This Trial?
Interventions
- SKB264
SKB264 is already approved in China, European Union, United States for the following indications:
- Triple-negative breast cancer
- EGFR-mutated non-small cell lung cancer
- Clinical trials approved but no specific indications listed yet
- Clinical trials ongoing but no specific indications approved yet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Klus Pharma Inc.
Lead Sponsor