MelanomaPhase 1/2NCT06727630
A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma
A Phase 1/2 study testing PRJ1-3024 in people with Melanoma, run by Zhuhai Yufan Biotechnologies Co., Ltd at 1 site in China.
Trial summary
This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2024to 30 Oct 2025
- Phase
- Phase 1/2
- 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
None listed.
Who cannot join
- 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.
- Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to < Grade 2.
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- Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .
- Prior treatment with other hematopoietic progenitor kinase 1 (HPK1) inhibitors.
- Allergy to the ingredients of study drug, or a history of other allergies which were judged by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, Dr, 8610-88196348, guoj307@126.com
About this study
Official title: A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma
This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma
Read the detailed description
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRJ1-3024 and will determine the recommended dose in China subjects with unresectable local advanced or metastatic melanoma.
PRJ1-3024 is a small molecular Hematopoietic progenitor kinase (HPK-1) inhibitor. It will be evaluated as an oral therapeutic that tests the anti-tumor activity in patients with unresectable or metastatic melanoma and has not yet been tested in humans.
- Conditions
- Melanoma
- Being tested
- PRJ1-3024
- Keywords
- HPK-1 inhibitor;melanoma;PRJ1-3024;Recommended Phase 2 dose
- Medical subject headings
- Melanoma
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 / Monotherapy Backfill | Experimental | Dose escalation arm with PRJ1-3024 which will begin with 3-6 subjects treated at the lowest planned dose level based on previous phase Ia study results. PRJ1-3024 is administered orally once daily. The starting dose is 300mg/day.
After the small dose escalation, one or two dose backfill group will be tested to further explore the efficacy and safety of China patients with unresectable local advanced or metastatic melanoma. Receives: Drug: PRJ1-3024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Recommended phase 2 dose (RP2D)
To determine the RP2D in China advanced metastatic melanoma patients
Measured: 24 months
Secondary outcomes (8)
Duration of response (DOR)
Defined as time from the first occurrence of a documented objective response to the time of relapse or death from and cause.
Measured: 24 months
Progression-Free Survival (PFS)
Calculated from the start of treatment until the first occurrence of disease progression or death, whichever comes first.
Measured: 24 months
Disease control rate (DCR)
To access the response of patients, particularly whether the treatment is able to shrink or stabilize the tumor.
Measured: 24 months
Pharmacokinetic parameters (PK)
Peak Plasma Concertration(Cmax)
Measured: 24 months
Incidence of adverse events (AEs)
Characterized by type, seriousness, relationship to study treatment, timing, and severity
Measured: 24 months
Pharmacokinetic parameters (PK)
Minimum Concertration
Measured: 24 months
Pharmacokinetic parameters (PK)
Time to peak drug concentration(Tmax)
Measured: 24 months
Pharmacokinetic parameters(PK)
Area under the plasma concentration versus time curve (AUC)
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 posted11 Dec 2024
- Study start14 Mar 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai Yufan Biotechnologies Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hui Ouyang, Dr., Study director, VP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727630
- Sponsor's protocol ID
- PRJ1-3024-003
- Status last verified
- Oct 2024
- First submitted
- 4 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT06727630
- Acronym / sponsor ID
- PRJ1-3024-003
- Conditions
- Melanoma
- Keywords
- HPK-1 inhibitor;melanoma;PRJ1-3024;Recommended Phase 2 dose
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhuhai Yufan Biotechnologies Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 11 Dec 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.
This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma
Detailed description
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRJ1-3024 and will determine the recommended dose in China subjects with unresectable local advanced or metastatic melanoma.
PRJ1-3024 is a small molecular Hematopoietic progenitor kinase (HPK-1) inhibitor. It will be evaluated as an oral therapeutic that tests the anti-tumor activity in patients with unresectable or metastatic melanoma and has not yet been tested in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Escalation / Monotherapy Backfill | Experimental | Drug: PRJ1-3024Dose escalation arm with PRJ1-3024 which will begin with 3-6 subjects treated at the lowest planned dose level based on previous phase Ia study results. PRJ1-3024 is administered orally once daily. The starting dose is 300mg/day. After the small dose escalation, one or two dose backfill group will be tested to further explore the efficacy and safety of China patients with unresectable local advanced or metastatic melanoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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.
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 / Monotherapy Backfill |
Primary outcome
Objective response rate (ORR)
Time frame: 24 months
Estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.
Recommended phase 2 dose (RP2D)
Time frame: 24 months
To determine the RP2D in China advanced metastatic melanoma patients
8 secondary outcomes
Duration of response (DOR)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Disease control rate (DCR)
Time frame: 24 months
Pharmacokinetic parameters (PK)
Time frame: 24 months
Incidence of adverse events (AEs)
Time frame: 24 months
Pharmacokinetic parameters (PK)
Time frame: 24 months
Pharmacokinetic parameters (PK)
Time frame: 24 months
Pharmacokinetic parameters(PK)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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. This study is not recruiting at the moment.
Hui Ouyang, Dr. study director
VP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRJ1-3024 in people with Melanoma, run by Zhuhai Yufan Biotechnologies Co., Ltd at 1 site in China.
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 0 inclusion and 9 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 11 Dec 2024. 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 China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Liting Lai, Bachelor (8617728075858, vivi.lai@ming-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 24 months). The study lists 2 primary outcomes in all. 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 11 Dec 2024.