Neoplasm MalignantPhase 1NCT03986606
A Study of PSB205 in Subjects With Advanced Solid Tumors
A Phase 1 study testing PSB205 in people with Neoplasm Malignant, run by Qilu Puget Sound Biotherapeutics (dba Sound Biologics) at 1 site in United States.
Trial summary
This is an open-label, multicenter, Phase 1, ascending dose escalation study of PSB205 in subjects with advanced solid tumors. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- PSB205
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 28 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female subjects aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Inclusion of subjects with an ECOG performance status of 2 should be discussed and is at the discretion of the sponsor's medical monitor and the investigator.
- Life expectancy of ≥3 months.
- Female subjects who are not pregnant or breastfeeding, 1 year postmenopausal, or surgically sterile and males even if surgically sterilized that Agree to practice effective barrier contraception during the entire study treatment period and through 180 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.
- Suitable venous access for the study-required blood sampling, including PK and Pharmacodynamic sampling.
- To be enrolled in Part 1 (Dose escalation), subjects must have:
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- Histologically confirmed diagnosis of advanced solid tumor and preferably radiographically or clinically measurable disease. Subjects with non-measurable, evaluable disease are permitted
- One or more prior lines of therapy . No curative options and progressed on or following standard of care therapy (SOC).
- To be enrolled in Part 2 (Dose expansion), subjects must have:
- Histologically confirmed diagnosis of advanced solid tumor of the following types, and radiographically or clinically measurable disease, one or more prior lines of therapy, no curative options and progressed on or following SOC.
- Squamous cell carcinomas- squamous non-small cell lung cancer (NSCLC) or squamous cell carcinoma of the head and neck (HNSCC)
- Locally advanced or metastatic gastric or gastroesophageal carcinoma
- Advanced or metastatic renal cell Carcinoma (clear cell, papillary, other)
- MSI-high colon carcinoma
- Small cell lung cancer
- Advanced urothelial cancer
- Metastatic melanoma I. Advanced soft-tissue or bone sarcoma
Who cannot join
- Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Grade 3 or Grade 4 irAEs related to prior cancer immunotherapy.
- Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression. Subjects previously treated central nervous system metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 14 days prior to first dose of study drug are permitted to enroll.
- Hypertension unable to be controlled to ≤Grade 2 with medication.
- Any condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before first dose of study drug. Corticosteroids for topical use, nasal spray, and inhaled steroids are allowed. Systemic corticosteroids for prophylaxis of contrast allergy are permitted.
- Prior treatment with a CTLA-4 inhibitor in combination with a PD-1 or PD-L1 inhibitor.
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- Systemic anti-cancer treatment (including investigational agents). This includes radiotherapy <2 weeks before the first dose of study drug, ≤4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T cell engaging agents; (≤8 weeks for cell-based therapy or anti-tumor vaccine) or have not recovered from acute toxic effects from prior chemotherapy and radiotherapy.
- Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
- Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
- Subjects with a history of organ transplant.
- Hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.
- Known human immunodeficiency virus (HIV) positive.
- Subjects with any of the following cardiovascular conditions are excluded:
- Acute myocardial infarction within 6 months before first dose of study drug.
- Current or history of New York Heart Association Class III or IV heart failure.
- Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
- Subject has a history of alcoholism or drug abuse within the past 6 months.
- Vaccinations within 4 weeks of first dose of study drug.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Next Oncology
San Antonio, Texas, 78229
Anthony Tolcher, MD
MD
About this study
Official title: A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients With Relapsed/Refractory Solid Tumors
This is an open-label, multicenter, Phase 1, ascending dose escalation study of PSB205 in subjects with advanced solid tumors. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of PSB205. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of PSB205 in subjects with solid tumors. Part 2 of the study will further evaluate the RP2D in 3 distinct tumor cohorts of approximately 12 subjects each.
- Conditions
- Neoplasm Malignant
- Being tested
- PSB205
- Keywords
- neoplasm, checkpoint inhibitor, combination, immunotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSB205Biological
PSB205 is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.
| Study group | Role | What they receive |
|---|---|---|
| Open-label Dose Escalation and Expansion Study of PSB205 | Experimental | Part 1 (Dose escalation): PSB205 will be administered in sequential cohorts of 3 to 6 subjects each receiving 1 of 5 doses of PSB205 on day 1 of every 21-day cycle (3 weeks) via IV infusion using a standard 3+3 dose escalation design. Dose escalation will continue until an MTD is reached.
Part 2 (Dose Expansion): The clinical anti-tumor effects of PSB205 will be tested at the recommended Phase 2 dose (RP2D) determined during the dose-escalation phase in subjects from three different solid tumor cohorts. Receives: Biological: PSB205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start5 Jul 2019
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MalignantStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Puget Sound Biotherapeutics (dba Sound Biologics)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986606
- Sponsor's protocol ID
- PSB205-001
- Status last verified
- Nov 2020
- First submitted
- 4 Jun 2019
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients With Relapsed/Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT03986606
- Acronym / sponsor ID
- PSB205-001
- Conditions
- Neoplasm Malignant
- Keywords
- neoplasm, checkpoint inhibitor, combination, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Qilu Puget Sound Biotherapeutics (dba Sound Biologics)Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Jul 2021 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, Phase 1, ascending dose escalation study of PSB205 in subjects with advanced solid tumors. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of PSB205. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of PSB205 in subjects with solid tumors. Part 2 of the study will further evaluate the RP2D in 3 distinct tumor cohorts of approximately 12 subjects each.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label Dose Escalation and Expansion Study of PSB205 | Experimental | Biological: PSB205Part 1 (Dose escalation): PSB205 will be administered in sequential cohorts of 3 to 6 subjects each receiving 1 of 5 doses of PSB205 on day 1 of every 21-day cycle (3 weeks) via IV infusion using a standard 3+3 dose escalation design. Dose escalation will continue until an MTD is reached. Part 2 (Dose Expansion): The clinical anti-tumor effects of PSB205 will be tested at the recommended Phase 2 dose (RP2D) determined during the dose-escalation phase in subjects from three different solid tumor cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female subjects aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Inclusion of subjects with an ECOG performance status of 2 should be discussed and is at the discretion of the sponsor's medical monitor and the investigator.
- Life expectancy of ≥3 months.
- Female subjects who are not pregnant or breastfeeding, 1 year postmenopausal, or surgically sterile and males even if surgically sterilized that Agree to practice effective barrier contraception during the entire study treatment period and through 180 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.
- Suitable venous access for the study-required blood sampling, including PK and Pharmacodynamic sampling.
Key exclusion criteria (19 listed)
- Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Grade 3 or Grade 4 irAEs related to prior cancer immunotherapy.
- Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression. Subjects previously treated central nervous system metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 14 days prior to first dose of study drug are permitted to enroll.
- Hypertension unable to be controlled to ≤Grade 2 with medication.
- Any condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before first dose of study drug. Corticosteroids for topical use, nasal spray, and inhaled steroids are allowed. Systemic corticosteroids for prophylaxis of contrast allergy are permitted.
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 |
|---|---|---|
| PSB205PSB205 is a bi-functional product that has been engineered to contain two unique monoclonal antibodies. | Biological | Open-label Dose Escalation and Expansion Study of PSB205 |
Primary outcome
Safety and tolerability
Time frame: 28 days
Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PSB205 in people with Neoplasm Malignant, run by Qilu Puget Sound Biotherapeutics (dba Sound Biologics) at 1 site 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 17 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Erdman (1-913-410-2815, ErdmanCynthia@prahs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 28 days). 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 25 Nov 2020.