80 Participants Needed

PQ203 for Breast Cancer

Recruiting at 2 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

Documented presence of RECIST v1.1 measurable disease
My organ functions are within normal ranges according to recent tests.
I am 18 years old or older.
See 5 more

Exclusion Criteria

QTc interval using Fridericia's formula (QTcF) > 470 ms
Known/suspected pregnancy and/or lactation
Diastolic blood pressure < 60 mmHg or >110 mmHg
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Varies by cohort
Weekly visits for infusion

Phase 1B: Dose Optimization

Assessment of the provisional RP2D to further characterize safety, pharmacokinetics, and preliminary efficacy.

Varies by cohort
Weekly visits for infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PQ203
Trial Overview The study is testing the safety and tolerability of a new drug called PQ203 in patients who have advanced cancers. It aims to find the right dose level of PQ203 that could be used in future Phase 2 trials specifically for TNBC.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: PQ203Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ProteinQure Inc.

Lead Sponsor

Citations

PQ203 in Advanced Malignant Tumors Including Triple ...The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including ...
2.proteinqure.comproteinqure.com/pipeline/
ProteinQure - PipelinePQ203, our most advanced AI-designed peptide-drug conjugate, is currently in a Phase 1 clinical trial in patients with advanced solid tumors, including those ...
ProteinQure Announces First Patient Dosed in Phase I ...ProteinQure has generated data that PQ203 exhibits potent efficacy in a patient-derived xenograft (PDX) model resistant to Sacituzumab Govitecan ...
PQ203 Receives Regulatory Clearance for Breast Cancer ...Preclinical data cited by ProteinQure, which includes efficacy in patient-derived xenograft models, showed that PQ203 was effective even in ...
PQ203 for Breast CancerThe primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including ...
Abstract P4-12-17: Pre-clinical data and phase I design for PQ ...Conclusions: PQ203 exhibits promising pre-clinical efficacy and safety in targeting SORT1-positive TNBC. These findings support the initiation ...
PQ203 in Advanced Malignant Tumors Including Triple ...The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including ...
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