Advanced Solid TumorPhase 1NCT04430348
PTX-35 in Patients With Advanced Solid Tumors
A Phase 1 study testing PTX-35 in people with Advanced Solid Tumor, run by Pelican Therapeutics, Inc. at 3 sites in United States.
Trial summary
A Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety of the Monoclonal Antibody PTX-35 in Patients with Advanced Solid Tumors Refractory to Standard of Care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- PTX-35
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Jun 2020to 15 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- In order to participate in this study, a patient must:
- Be willing and have the capacity to sign the written informed consent form.
- Be male or female of at least 18 years of age at the time of signing informed consent.
- Have a documented diagnosis of metastatic or advanced, unresectable solid tumor disease. Patient must have progressed or recurred following standard of care (SOC) therapies, or are ineligible for, or who refuse other safe and effective SOC therapies, and whom the Investigator believes may benefit from experimental treatment with PTX-35.
- Have an acceptable organ function, as defined below:
- Albumin ≥ 2.5 g/dL
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- Total bilirubin < 3.0 × upper limit of normal (ULN), unless patient has Gilbert's syndrome
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × ULN, or
- 5 × ULN in the case of liver metastases
- Calculated or measured creatinine clearance > 35 mL/minute per the Cockcroft-Gault formula
- Absolute neutrophil count ≥ 1,500/mm3
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/mm3
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have life expectancy of at least three months.
- Patients, both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the trial and for six months after the last treatment with PTX-35.
Who cannot join
- In order to participate in this study, a patient must not:
- Have received any systemic anticancer therapy including small molecules, chemotherapy, radiation therapy, monoclonal antibodies or any other experimental drug within 4 weeks of first dose of PTX-35. Adjuvant anti hormonal treatment(s) for prior breast cancer or prostate cancer are allowed. (Note: washout for palliative radiation therapy is 2 weeks).
- Have clinically significant cardiac disease, including:
- Onset of unstable angina within 6 months of signing the Informed Consent Form (ICF).
- Acute myocardial infarction within 6 months of the signing the ICF.
- Known congestive heart failure (Grade III or IV as classified by the New York Heart Association); and/ or a known decreased cardiac ejection fraction (LVEF) of < 45%.
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- Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management.
- Have known or clinically suspected leptomeningeal disease. Stable, previously treated metastases in the brain or spinal cord, are allowed as long as these are considered stable (by CT or MRI), and not requiring systemic corticosteroids.
- Have a history of ≥ Grade 3 allergic reactions, or suspected allergy or intolerance to monoclonal antibody therapies.
- Have a history of suspected cytokine release syndrome (CRS).
- Have any known immunodeficiency disorders (testing not required).
- Have received prior allogeneic stem cell transplant.
- Have ongoing or current autoimmune disease. Permanent but stable and manageable immune related adverse events (irAE) from prior therapies are permissible, if prednisone equivalent corticosteroid use does not exceed 10 mg/day.
- Have any other condition requiring concurrent systemic immunosuppressive therapy (other than allowable exceptions which do not exceed 10mg/day of prednisone/corticosteroid use).
- Have clinically significant active viral, bacterial or fungal infection requiring:
- Intravenous treatment with antimicrobial therapy completed less than two weeks prior to first dose, or
- Oral treatment with antimicrobial therapy completed less than one week prior to first dose. Prophylactic treatment with antibiotics (e.g. for dental extractions) is allowed.
- Have had major surgery (requiring general anesthesia or inpatient hospitalization) within four weeks before first administration of PTX-35.
- Have had a known tetanus/diphtheria vaccine within the past 10 years.
- Have known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least two years.
- Have known previously untreated or symptomatic metastases in the brain or spinal cord requiring steroids. Patients with treated and stable CNS metastases may be enrolled after approval of the sponsor and/or Medical Monitor.
- Have any other ongoing significant, uncontrolled medical condition in the opinion of the Investigator.
- Have known positive serology for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (except in cases of immunity after cured infection). Testing not required.
- Have a history of substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial result.
- Be a female patient who is pregnant or breast feeding.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NEXT Oncology Austin
Austin, Texas, 78705
Providence Cancer Institute, Earle A. Chiles Research Institute
Portland, Oregon, 97213
Next Oncology
San Antonio, Texas, 78229
About this study
Official title: PTX35-001 A Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety of the Monoclonal Antibody PTX-35 in Patients With Advanced Solid Tumors Refractory to Standard of Care
A Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety of the Monoclonal Antibody PTX-35 in Patients with Advanced Solid Tumors Refractory to Standard of Care
Read the detailed description
This is an open-label, single arm, first-in-human, Phase I study of intravenous administration of PTX-35 to patients with advanced solid tumors refractory to, or ineligible for, or who refuse available SOC. Five escalating dose levels of PTX-35 will be explored using a traditional 3+3 design based on dose-limiting toxicities (DLTs) until optimal immunological dose (OID) or maximum tolerated dose (MTD) is established.
- Conditions
- Advanced Solid Tumor
- Being tested
- PTX-35
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTX-35Drug
Monoclonal antibody PTX-35
| Study group | Role | What they receive |
|---|---|---|
| PTX-35 Dose Level 1 | Experimental | Dose Level 1: PTX-35 0.01 mg/kg Receives: Drug: PTX-35 |
| PTX-35 Dose Level 2 | Experimental | Dose Level 2: PTX-35 0.03 mg/kg Receives: Drug: PTX-35 |
| PTX-35 Dose Level 3 | Experimental | Dose Level 3: PTX-35 0.10 mg/kg Receives: Drug: PTX-35 |
| PTX-35 Dose Level 4 | Experimental | Dose Level 4: PTX-35 0.30 mg/kg Receives: Drug: PTX-35 |
| PTX-35 Dose Level 5 | Experimental | Dose Level 5: PTX-35 1.0 mg/kg Receives: Drug: PTX-35 |
| PTX-35 Dose Level 6 | Experimental | Dose Level 6: PTX-35 3.0 mg/kg Receives: Drug: PTX-35 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With Any Treatment-emergent Adverse Events (TEAEs) During the Trial
TEAEs during the trial
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start4 Jun 2020
- Primary completion2 Nov 2022
- Study completion15 Jun 2023
Why it stopped: Absence of immunological response
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pelican Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony W Tolcher, MD, Principal investigator, Next Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430348
- Sponsor's protocol ID
- PTX35-001
- Status last verified
- Aug 2023
- First submitted
- 4 Jun 2020
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTX35-001 A Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety of the Monoclonal Antibody PTX-35 in Patients With Advanced Solid Tumors Refractory to Standard of Care
- ClinicalTrials.gov ID
- NCT04430348
- Acronym / sponsor ID
- PTX35-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Absence of immunological response
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Pelican Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety of the Monoclonal Antibody PTX-35 in Patients with Advanced Solid Tumors Refractory to Standard of Care
Detailed description
This is an open-label, single arm, first-in-human, Phase I study of intravenous administration of PTX-35 to patients with advanced solid tumors refractory to, or ineligible for, or who refuse available SOC. Five escalating dose levels of PTX-35 will be explored using a traditional 3+3 design based on dose-limiting toxicities (DLTs) until optimal immunological dose (OID) or maximum tolerated dose (MTD) is established.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PTX-35 Dose Level 1 | Experimental | Drug: PTX-35Dose Level 1: PTX-35 0.01 mg/kg |
| PTX-35 Dose Level 2 | Experimental | Drug: PTX-35Dose Level 2: PTX-35 0.03 mg/kg |
| PTX-35 Dose Level 3 | Experimental | Drug: PTX-35Dose Level 3: PTX-35 0.10 mg/kg |
| PTX-35 Dose Level 4 | Experimental | Drug: PTX-35Dose Level 4: PTX-35 0.30 mg/kg |
| PTX-35 Dose Level 5 | Experimental | Drug: PTX-35Dose Level 5: PTX-35 1.0 mg/kg |
| PTX-35 Dose Level 6 | Experimental | Drug: PTX-35Dose Level 6: PTX-35 3.0 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Be willing and have the capacity to sign the written informed consent form.
- Be male or female of at least 18 years of age at the time of signing informed consent.
- Have a documented diagnosis of metastatic or advanced, unresectable solid tumor disease. Patient must have progressed or recurred following standard of care (SOC) therapies, or are ineligible for, or who refuse other safe and effective SOC therapies, and whom the Investigator believes may benefit from experimental treatment with PTX-35.
- Have an acceptable organ function, as defined below:
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (25 listed)
- Have received any systemic anticancer therapy including small molecules, chemotherapy, radiation therapy, monoclonal antibodies or any other experimental drug within 4 weeks of first dose of PTX-35. Adjuvant anti hormonal treatment(s) for prior breast cancer or prostate cancer are allowed. (Note: washout for palliative radiation therapy is 2 weeks).
- Have clinically significant cardiac disease, including:
- Have known or clinically suspected leptomeningeal disease. Stable, previously treated metastases in the brain or spinal cord, are allowed as long as these are considered stable (by CT or MRI), and not requiring systemic corticosteroids.
- Have a history of ≥ Grade 3 allergic reactions, or suspected allergy or intolerance to monoclonal antibody therapies.
- Have a history of suspected cytokine release syndrome (CRS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTX-35Monoclonal antibody PTX-35 | Drug | PTX-35 Dose Level 1, PTX-35 Dose Level 2, PTX-35 Dose Level 3, PTX-35 Dose Level 4, PTX-35 Dose Level 5, PTX-35 Dose Level 6 |
Primary outcome
Subjects With Any Treatment-emergent Adverse Events (TEAEs) During the Trial
Time frame: Up to 12 months
TEAEs during the trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony W Tolcher, MD principal investigator
Next Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PTX-35 in people with Advanced Solid Tumor, run by Pelican Therapeutics, Inc. at 3 sites in United States.
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 16 inclusion and 25 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: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects With Any Treatment-emergent Adverse Events (TEAEs) During the Trial (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024; AzTrials last refreshed its copy on 27 Oct 2026.