PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "PQ203 will be administered as a once-weekly intravenous infusion."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of PQ203 and how well people can tolerate it. It is for adults with advanced solid tumors, including triple-negative breast cancer. It also aims to find a dose for future studies in triple-negative breast cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old.
- Have a solid tumor confirmed by tissue or cell tests that has spread nearby or to other parts of the body. Standard treatments must have stopped working or not be an option.
- Be fully active or able to do light work, with limits only on hard physical activity.
- Have cancer that can be measured using the study’s rules.
- Have blood tests within 14 days before the first dose showing that blood cell counts, liver and kidney function, and blood clotting meet study limits.
- Have a heart that pumps out at least 50% of the blood in its main pumping chamber with each beat.
- Understand and sign the consent form before study tests. If able to have children, agree to use highly effective birth control through at least 4 months after the last dose.
- Have side effects from past cancer treatment that have gone away or are no more than mild.
Who can't join
- Have cancer that started in the brain or spinal cord. Cancer that spread to the brain is allowed if stable for at least 4 weeks after treatment and no longer needs steroids or other treatment.
- Have serious health problems that could affect treatment, an uncontrolled illness, past severe heart disease, a heart electrical timing test above 470 milliseconds, or a bottom blood pressure number below 60 or above 110.
- Weigh more than 115 kg (253 pounds); be pregnant, possibly pregnant, or breastfeeding; or live in a long-term care facility or prison.
- Have ever received a drug containing MMAE or a medicine targeting SORT1.
- Have had a blood transfusion within 14 days, major surgery within 28 days, or a stroke within 6 months before study treatment.
- Have joined another study of a drug, device, or nonstandard brain or nerve procedure or surgery in the 30 days before enrollment.
- Have had recent chemotherapy or other whole-body cancer treatment: within 14 days or 5 drug half-lives, whichever is shorter. A half-life is the time for half the drug to leave the body. For nitrosoureas or mitomycins, the limit is 42 days.
- Have eye damage causing symptoms; nerve damage outside the brain and spinal cord that is more than mild; or certain lung inflammation or scarring that is current, suspected, or previously needed steroids.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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) * 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
Study sites (3)
TX
- MD Anderson Cancer Center · Houston, TX 77030Desirae Dufner · Study contact · 713-745-7813 · DDufner@mdanderson.orgTimothy A Yap, MBBS, PhD, FRCP · Principal investigatorMore trials in Houston
- NEXT Oncology · San Antonio, TX 78229nxt_txreferrals@nextoncology.com · Study contact · 210-580-9500 · nxt_txreferrals@nextoncology.comDavid Sommerhalder, MD · Principal investigatorMore trials in San Antonio
UT
- START Mountain Region · West Valley City, UT 84119Olivia Darais · Study contact · 801-917-4750 · olivia.darais@startresearch.comMore trials in West Valley City