Advanced CancerPhase 1NCT06190886
A First-in-human (FIH), Phase I Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors
A Phase 1 study testing PTX-912 in people with Advanced Cancer and Solid Tumor, run by Proviva Therapeutics, Inc. at 3 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of PTX-912 in patients with locally advanced or metastatic solid tumors. To evaluate the PK and immunogenicity profile of PTX-912. To evaluate the preliminary anti-tumor activity of PTX-912. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Solid Tumor, Metastatic Cancer
- What is being tested?
- PTX-912
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jun 2024to 24 Jul 2026
- 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
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Male and Female patients age ≥ 18 years on day of signing informed consent.
- Willing to comply with all protocol-required visits, assessments, and procedures.
- Patients with locally advanced or metastatic solid tumors who have had disease progression on all available standard of care or for whom no reasonable standard of care exists that would confer clinical benefit.
- Recovery from all toxicities associated with prior therapy to acceptable baseline status (for laboratory toxicities, see limits for inclusion). NCI CTCAE v5.0 Grade 0 or 1, except for toxicities not considered a safety risk (e.g., alopecia or vitiligo).
- Measurable disease per RECIST v1.1.
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- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration during Screening.
- Adequate bone marrow and organ function, defined by the following laboratory results obtained within 14 days before first dose of study drug.
- Patients with recent major surgery must have adequately recovered with no ongoing complications from the surgery prior to receiving study treatment.
- Willingness to adhere to the study treatment-specific contraception requirements.
- Estimated life expectancy of 3 months (12 weeks) or greater as determined by Investigator.
Who cannot join
- Has a diagnosis of immunodeficiency.
- Has an active infection requiring systemic therapy within 4 weeks prior to study treatment.
- History of or known intolerance, significant hypersensitivity, or anaphylaxis to any components of PTX-912 or any of the excipients.
- Unresolved toxicities from prior systemic therapy greater than NCI CTCAE grade 1 at time of first dose, except alopecia, vitiligo, and grade 2 neuropathy due to prior chemotherapy.
- Experienced clinically significant immune-related toxicity from prior immunotherapy that in the opinion of the investigator would preclude protocol therapy or would make the patient inappropriate for the study.
- Major surgery within 30 days prior to first dose of study drug (with the below exceptions), or anticipation of major surgery during study treatment.
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- Active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
- Uncontrolled diabetes mellitus or other uncontrolled immune-related endocrinopathies in the opinion of the investigator.
- Primary central nervous system (CNS) disease or leptomeningeal disease.
- Impaired cardiovascular function or clinically significant cardiovascular disease.
- Abnormal pulmonary function within the previous 6 months, including history of pneumonitis, active pneumonitis, interstitial lung disease requiring the use of steroids, idiopathic pulmonary fibrosis, active pleural effusion, severe dyspnea at rest or requiring supplementary oxygen therapy.
- History of allogenic, bone marrow, or solid organ transplants.
- Received a live-virus vaccination ≤14 days prior to first dose of study drug (seasonal flu and other inactivated vaccines that do not contain live virus are permitted).
- Clinically significant bleeding within 2 weeks prior to first dose of study drug dy.
- Pregnant or breast-feeding women or expecting to conceive within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of study drug.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
Principal Investigator Yan Xing, MD., M.S, Ph.D, 626-218-3582, yxing@coh.org
- Recruiting
University of Miami
Miami, Florida, 33136
Manager Research Support Phase 1, Nailet Real Bestard, M.S., 305-243-8173, nxr518@med.miami.edu
- Recruiting
Nebraska Cancer Specialists (NCS)
Omaha, Nebraska, 68130
Director of Clinical Research, 402-955-2691, aservais@nebraskacancer.com
About this study
Official title: A First-in-human (FIH), Multicenter, Open-Label, Phase Ia (Dose Escalation)/Phase Ib (Dose Expansion) Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors
The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of PTX-912 in patients with locally advanced or metastatic solid tumors. To evaluate the PK and immunogenicity profile of PTX-912. To evaluate the preliminary anti-tumor activity of PTX-912.
Participants will be treated with PTX-912 via iv infusion, every 2 weeks until progression of disease, unacceptable toxicity, or 12 months of total study therapy.
- Conditions
- Advanced Cancer, Solid Tumor, Metastatic Cancer
- Being tested
- PTX-912
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTX-912Drug
Investigation Product Monotherapy
| Study group | Role | What they receive |
|---|---|---|
| PTX-912 | Experimental | Single or multiple ascending dose of PTX-912 Receives: Drug: PTX-912 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs (dose limiting toxicity)
Frequency, severity, and duration of treatment-emergent adverse events (TEAEs) and laboratory abnormalities for all dose groups according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0; except for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) which will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading.
Measured: within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start11 Jun 2024
- Primary completion14 May 2026 (estimated)
- Study completion24 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proviva Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190886
- Sponsor's protocol ID
- PTX-912-001
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2023
- Last updated
- 7 Nov 2024
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human (FIH), Multicenter, Open-Label, Phase Ia (Dose Escalation)/Phase Ib (Dose Expansion) Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06190886
- Acronym / sponsor ID
- PTX-912-001
- Conditions
- Advanced Cancer, Solid Tumor, Metastatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Proviva Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 24 Jul 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of PTX-912 in patients with locally advanced or metastatic solid tumors. To evaluate the PK and immunogenicity profile of PTX-912. To evaluate the preliminary anti-tumor activity of PTX-912.
Participants will be treated with PTX-912 via iv infusion, every 2 weeks until progression of disease, unacceptable toxicity, or 12 months of total study therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTX-912 | Experimental | Drug: PTX-912Single or multiple ascending dose of PTX-912 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Male and Female patients age ≥ 18 years on day of signing informed consent.
- Willing to comply with all protocol-required visits, assessments, and procedures.
- Patients with locally advanced or metastatic solid tumors who have had disease progression on all available standard of care or for whom no reasonable standard of care exists that would confer clinical benefit.
- Recovery from all toxicities associated with prior therapy to acceptable baseline status (for laboratory toxicities, see limits for inclusion). NCI CTCAE v5.0 Grade 0 or 1, except for toxicities not considered a safety risk (e.g., alopecia or vitiligo).
Key exclusion criteria (15 listed)
- Has a diagnosis of immunodeficiency.
- Has an active infection requiring systemic therapy within 4 weeks prior to study treatment.
- History of or known intolerance, significant hypersensitivity, or anaphylaxis to any components of PTX-912 or any of the excipients.
- Unresolved toxicities from prior systemic therapy greater than NCI CTCAE grade 1 at time of first dose, except alopecia, vitiligo, and grade 2 neuropathy due to prior chemotherapy.
- Experienced clinically significant immune-related toxicity from prior immunotherapy that in the opinion of the investigator would preclude protocol therapy or would make the patient inappropriate for the study.
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-912Investigation Product Monotherapy | Drug | PTX-912 |
Primary outcome
DLTs (dose limiting toxicity)
Time frame: within 28 days
Frequency, severity, and duration of treatment-emergent adverse events (TEAEs) and laboratory abnormalities for all dose groups according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0; except for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) which will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- 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.
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-912 in people with Advanced Cancer and Solid Tumor, run by Proviva 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 11 inclusion and 15 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 7 Nov 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?
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?
Contact Project Manager (425-233-1480, ze.zhang@provivatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs (dose limiting toxicity) (time frame: within 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 7 Nov 2024.