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Triple Negative Breast Cancer (TNBC)Phase 1NCT07190469

PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer

A Phase 1 study testing PQ203 in people with Triple Negative Breast Cancer (TNBC) and Advanced Solid Tumors Cancer, run by ProteinQure Inc. at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including triple negative breast cancer (TNBC), and to determine a recommended Phase 2 dose level for future studies in TNBC. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PQ203
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
4 sitesin 2 countries
Study dates
16 Sep 2025to Feb 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years old
  • Histologically or cytologically documented metastatic or locally advanced solid tumor malignancies having progressed through or being otherwise ineligible to receive approved standard-of-care therapies
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Documented presence of RECIST v1.1 measurable disease
  • Adequate organ function confirmed by the following laboratory values obtained within 14 days of the first dose of PQ203:
  • Bone Marrow Function
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  • Absolute neutrophil count (ANC) ≥ 1.5 × 10e9/L
  • Platelets > 100 × 10e9/L
  • Hemoglobin ≥ 9 g/dL
  • Hepatic Function
  • AST, alanine transaminase ALT or ALP ≤ 2.5 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
  • Bilirubin ≤ 1.5 × ULN (< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome)
  • Serum albumin ≥ 35 g/L (3.5 g/dL)
  • Renal Function
  • Calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault equation
  • Urine protein < 2+
  • Cardiac Function
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • Other
  • Understand and voluntarily sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Research Ethics Board (REB)-approved informed consent form prior to any study-specific evaluation.
  • PT/PTT or INR <1.2x upper limit of normal
  • Non-surgically sterile men and women of child bearing potential must agree to use highly effective methods of contraception for at least 4 months beyond the final dose received.
  • Toxicity of previous antitumor therapy has returned to Grade ≤1

Who cannot join

  • Patients with primary central nervous system (CNS) malignancies (Patients with stable brain metastases (≥ 4 weeks after a treatment) not requiring steroids or other treatment will be allowed on study).
  • Blood transfusion within 14 days of study treatment
  • Serious comorbid medical conditions such as heart, lung, kidney, liver, and brain disease that, in the opinion of the enrolling investigator, could interfere with study treatment
  • Subjects with history of severe heart disease
  • QTc interval using Fridericia's formula (QTcF) > 470 ms
  • Estimated or known weight > 115 kg (253 lbs)
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  • Known/suspected pregnancy and/or lactation
  • Diastolic blood pressure < 60 mmHg or >110 mmHg
  • Uncontrolled intercurrent illness
  • Long term care facility resident or prisoner
  • Any prior receipt of a MMAE-containing drug
  • Any prior receipt of a SORT1-targeting medication
  • Participation in another clinical study investigating a drug or medical device or a neuro-interventional or surgical procedure that is not considered as standard care in the 30 days preceding study enrolment
  • Treatment with any of the following:
  • Chemotherapy or other systemic anti-cancer therapy ≤14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug except for Nitrosoureas or mitomycins ≤42 days
  • Major surgery ≤28 days from first dose of study drug
  • Patients with a history of cerebrovascular accident within 6 months of planned first dose.
  • Patients with clinically symptomatic ocular toxicities
  • Patients with history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that require steroids, with current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Patients with active Grade >1 peripheral neuropathy

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

4 sites in 2 countries

United States3 sites, 3 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Desirae Dufner, 713-745-7813, DDufner@mdanderson.org

    Timothy A Yap, MBBS, PhD, FRCP

    Recruiting

  • NEXT Oncology

    San Antonio, Texas, 78229

    nxt_txreferrals@nextoncology.com, 210-580-9500, nxt_txreferrals@nextoncology.com

    David Sommerhalder, MD

    Recruiting

  • START Mountain Region

    West Valley City, Utah, 84119

    Olivia Darais, 801-917-4750, olivia.darais@startresearch.com

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 0C6

    Clinical Cancer Research Unit, 416-946-4559, patientrelations@uhn.ca

    Philippe Bedard, MD

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 1, Open-label, Multicenter Clinical Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Anti-Cancer Activity of PQ203 in Patients With Advanced Solid Tumor Malignancies

The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including triple negative breast cancer (TNBC), and to determine a recommended Phase 2 dose level for future studies in TNBC.

Read the detailed description

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PQ203 in patients with selected advanced solid tumors. PQ203 will be administered as a once-weekly intravenous infusion.

The study consists of two parts: Phase 1A (dose escalation/expansion) and Phase 1B (dose optimization).

  • Phase 1A will employ a dose-escalation design in patients with advanced solid tumors to assess the safety and tolerability of PQ203 as monotherapy and to establish a provisional Recommended Phase 2 Dose (RP2D). A dose-expansion component will further evaluate the provisional RP2D in one or more selected tumor types.
  • Phase 1B will assess the provisional RP2D and further characterize safety, pharmacokinetics, and preliminary efficacy.

Endpoints:

  • Primary Endpoints: Incidence of treatment-emergent adverse events (TEAEs) and determination of the RP2D.
  • Secondary Endpoints: Pharmacokinetic profile of PQ203 and its payload (MMAE), and preliminary evidence of antitumor activity.
Being tested
PQ203
Keywords
Triple Negative Breast Cancer, TNBC, PQ203, advanced solid tumors, Phase 1
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PQ203Drug

    PQ203 is a peptide drug-conjugate given once weekly by intravenous infusion intended for the treatment of advanced solid tumor cancers including triple negative breast cancer.

Study groups in NCT07190469
Study groupRoleWhat they receive
PQ203ExperimentalA Phase 1, first-in-human (FIH), multiple ascending dose study of the peptide drug-conjugate PQ203 to evaluate the safety, pharmacokinetics, tolerability and preliminary anti-cancer activity in patients with advanced cancers with solid tumors. Comprises up to 7 planned ascending dose cohorts with expansion of doses to identify recommended dose levels for testing in the Phase 1B Dose Optimization study. This is an open label study and all participants will receive PQ203.
Receives: Drug: PQ203

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent Adverse Events

    The incidence and severity of Adverse Events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) to assess safety and tolerability.

    Measured: From the time of informed consent until ~28 days after the last dose of PQ203

  2. Objective Response Rate (ORR)

    Tumor growth will be assessed using standard imaging techniques and scored by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). An Objective response rate (ORR), defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) will be calculated to assess preliminary signals of anti-tumor activity.

    Measured: From informed consent until ~28 days after the last dose of PQ203

Secondary outcomes (5)

  1. Progression free survival

    Progression free survival (PFS; time from first dose to date of documentation of disease progression) in months will be determined.

    Measured: From informed consent to ~28 days after the last dose of PQ203

  2. Pharmacokinetics: Determine the Cmax of PQ203

    Plasma concentration-time profiles will be used to identify the maximum drug concentration in plasma (ng PQ203/mL)

    Measured: From first day of dosing to ~28 days after the last day of dosing

  3. Pharmacokinetics: half-life of PQ203 in plasma

    Plasma concentration-time profiles will be used to determine the half life (in hours) of PQ203 in plasma

    Measured: From first day of dosing until ~28 days after the last dose

  4. Pharmacokinetics: PQ203 exposure

    Plasma concentration-time profiles will be used to determine the area under the curve (AUC) in ng/mL x hours

    Measured: from first dose through ~28 days after the last dose

  5. Duration of Objective Response

    Duration of objective response (complete or partial response) by RECIST 1.1 in months

    Measured: From Informed consent to ~28 days after the final dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start16 Sep 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07190469
Sponsor's protocol ID
PQ203-001
Status last verified
Feb 2026
First submitted
19 Aug 2025
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data from PQ203-001 is planned to be shared in aggregate in a study publication.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PQ203 in people with Triple Negative Breast Cancer (TNBC) and Advanced Solid Tumors Cancer, run by ProteinQure Inc. at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent Adverse Events (time frame: From the time of informed consent until ~28 days after the last dose of PQ203). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07190469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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