PQ203 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, PQ203, to assess its safety and tolerability in individuals with advanced solid tumors, including triple-negative breast cancer. Researchers aim to determine the optimal dose for future studies. The trial is open to individuals with advanced cancer unresponsive to other treatments. Participants should have a solid tumor, no certain serious health issues, and must not have recently received specific drugs. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received chemotherapy or other systemic anti-cancer therapy within 14 days before the first dose of the study drug, except for certain drugs with longer requirements. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that PQ203 is likely to be safe for humans?
Research has shown that PQ203 is promising in early lab studies for treating triple-negative breast cancer (TNBC), as it did not cause major safety issues in those studies. PQ203 targets a specific protein in TNBC tumor tissue, potentially allowing it to act directly on cancer cells.
Currently, PQ203 is in Phase 1 testing with people, focusing on its safety and tolerability. This phase aims to identify any side effects and determine the appropriate dose. Researchers closely monitor participants for negative reactions. Regulators have approved the treatment, indicating it is considered safe enough for human testing. However, detailed safety information from these human trials is not yet available.12345Why do researchers think this study treatment might be promising?
Unlike standard treatments for breast cancer, which often include chemotherapy, hormone therapy, or targeted therapy, PQ203 represents a novel approach by using a peptide drug-conjugate. This treatment is unique because it combines a peptide with a drug, potentially allowing it to specifically target cancer cells while sparing healthy ones, which could lead to fewer side effects. Researchers are particularly excited about PQ203 because it offers a new mechanism of action that targets solid tumors, which might improve outcomes for patients with advanced breast cancer.
What evidence suggests that PQ203 might be an effective treatment for breast cancer?
Research has shown that PQ203 yields promising results in early lab studies, particularly for hard-to-treat cancers. PQ203 performed well in lab-grown cancer models that closely resemble human tumors, including those resistant to Sacituzumab Govitecan, a drug used for some breast cancers. These early findings suggest that PQ203 might be effective against challenging cancers like triple-negative breast cancer. However, further studies, including this trial where all participants will receive PQ203, are necessary to confirm these effects in humans.13467
Are You a Good Fit for This Trial?
This trial is for individuals with advanced solid tumors, including those with a specific breast cancer type known as triple negative breast cancer (TNBC). Participants should have a tumor that can be measured and must not have had prior treatment with similar drugs to PQ203.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1A: Dose Escalation/Expansion
Dose escalation to assess safety and tolerability of PQ203 as monotherapy and establish a provisional Recommended Phase 2 Dose (RP2D). Includes dose-expansion to further evaluate the RP2D.
Phase 1B: Dose Optimization
Assessment of the provisional RP2D to further characterize safety, pharmacokinetics, and preliminary efficacy.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PQ203
Find a Clinic Near You
Who Is Running the Clinical Trial?
ProteinQure Inc.
Lead Sponsor