Advanced Solid TumorPhase 1NCT05159700
A Phase I Study, Evaluating the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors
A Phase 1 study testing PRJ1-3024 in people with Advanced Solid Tumor and Advanced Solid Malignancies, run by Zhuhai Yufan Biotechnologies Co., Ltd at 6 sites in United States.
Trial summary
This is a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Advanced Solid Malignancies
- What is being tested?
- PRJ1-3024
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Mar 2022to 29 Jun 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
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.
- Male or non-pregnant, non-lactating female subjects age ≥18 years.
- ECOG Performance Status 0~2.
- Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .
- Life expectancy of >3 months, in the opinion of the Investigator.
- Able to take oral medications and willing to record daily adherence to investigational product.
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- Adequate hematologic parameters unless clearly due to the disease under study.
- Adequate renal and hepatic function
- Able to understand and willing to sign a written informed consent form.
Who cannot join
- History of another malignancy
- Known symptomatic brain metastases requiring >10 mg/day of prednisolone.
- Significant cardiovascular disease
- Known active HBV, HCV, AIDS-related illness.
- Has received a live vaccine within 30 days
- History of active autoimmune disorders or ongoing immunosuppressive therapy.
- Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .
- Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
NEXT Oncology
Austin, Texas, 73301
Christ Hospital
Cincinnati, Ohio, 21073
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
NEXT Oncology
Fairfax, Virginia, 22031
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
Mays Cancer Center
San Antonio, Texas, 78229
About this study
Official title: A Phase I, First-In-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors
This is a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors.
Read the detailed description
The study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.
PRJ1-3024 will be evaluated as an oral therapeutic that tests the anti-tumor activity of PRJ1-3024 in patients with solid tumors and has not yet been tested in humans.
This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors as a open-label, 3+3 dose escalation study.
- Conditions
- Advanced Solid Tumor, Advanced Solid Malignancies
- Being tested
- PRJ1-3024
- Keywords
- First in human, Maximum tolerated dose, Recommended Phase 2 dose, Dose Escalation, Hematopoietic progenitor kinase 1, PRJ1-3024
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRJ1-3024Drug
PRJ1-3024 is provided as capsules and is administered orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Escalation | Experimental | 3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day. Receives: Drug: PRJ1-3024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Safety listings and pharmacokinetic listings will be used for evaluation
Measured: Day 1 to Day 21
Secondary outcomes (6)
Incidence of adverse events (AEs)
Characterized by type, seriousness, relationship to study treatment, timing, and severity.
Measured: 24 months
Pharmacokinetic parameter： Accumulation ratio
to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration
Measured: 24 months
Objective response rate (ORR)
estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.
Measured: 24 months
Duration of response (DOR)
defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.
Measured: 24 months
Pharmacokinetic parameter：AUC（0-last）
Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration
Measured: 24 months
Pharmacokinetic parameter：Maximum observed concentration (Cmax)
assessed as time from time 0 to the time of the last quantifiable concentration
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start31 Mar 2022
- Primary completion17 Jul 2024
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuhai Yufan Biotechnologies Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Xu, PhD, Study director, Head of US Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159700
- Sponsor's protocol ID
- PRJ1-3024 CS101
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2021
- Last updated
- 15 Dec 2025
- Results posted
- No
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-In-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05159700
- Acronym / sponsor ID
- PRJ1-3024 CS101
- Conditions
- Advanced Solid Tumor, Advanced Solid Malignancies
- Keywords
- First in human, Maximum tolerated dose, Recommended Phase 2 dose, Dose Escalation, Hematopoietic progenitor kinase 1, PRJ1-3024
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zhuhai Yufan Biotechnologies Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 16 Dec 2021 (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 a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors.
Detailed description
The study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.
PRJ1-3024 will be evaluated as an oral therapeutic that tests the anti-tumor activity of PRJ1-3024 in patients with solid tumors and has not yet been tested in humans.
This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors as a open-label, 3+3 dose escalation study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024.
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Escalation | Experimental | Drug: PRJ1-30243+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.
- Male or non-pregnant, non-lactating female subjects age ≥18 years.
- ECOG Performance Status 0~2.
- Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .
- Life expectancy of >3 months, in the opinion of the Investigator.
Key exclusion criteria (8 listed)
- History of another malignancy
- Known symptomatic brain metastases requiring >10 mg/day of prednisolone.
- Significant cardiovascular disease
- Known active HBV, HCV, AIDS-related illness.
- Has received a live vaccine within 30 days
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 |
|---|---|---|
| PRJ1-3024PRJ1-3024 is provided as capsules and is administered orally once a day. | Drug | Monotherapy Escalation |
Primary outcome
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Time frame: Day 1 to Day 21
Safety listings and pharmacokinetic listings will be used for evaluation
6 secondary outcomes
Incidence of adverse events (AEs)
Time frame: 24 months
Pharmacokinetic parameter： Accumulation ratio
Time frame: 24 months
Objective response rate (ORR)
Time frame: 24 months
Duration of response (DOR)
Time frame: 24 months
Pharmacokinetic parameter：AUC（0-last）
Time frame: 24 months
Pharmacokinetic parameter：Maximum observed concentration (Cmax)
Time frame: 24 months
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 15 Dec 2025.
- 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.
Yang Xu, PhD study director
Head of US Clinical Development
6 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 PRJ1-3024 in people with Advanced Solid Tumor and Advanced Solid Malignancies, run by Zhuhai Yufan Biotechnologies Co., Ltd at 6 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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period (time frame: Day 1 to Day 21). 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 15 Dec 2025.