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Advanced Solid TumorPhase 1/2NCT05315167

A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors

A Phase 1/2 study testing PRJ1-3024 in people with Advanced Solid Tumor and Advanced Solid Malignancies, run by Zhuhai Yufan Biotechnologies Co., Ltd at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
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
267 participants
Where
5 sitesChina
Study dates
30 May 2022to 15 Nov 2027
Phase
Phase 1/2
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

None listed.

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 or ongoing .
Show all 9Show fewer
  • Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to < Grade 2.
  • 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

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liting Lai contact

8617728075858

vivi.lai@ming-med.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Lin Shen, Dr., 8610-88196561, doctorshenlin@sina.com

    Recruiting

  • The Fifth Medical Center of PLA General Hospital

    Beijing

    Guanghai Dai

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Yongsheng Wang

    Recruiting

  • Cancer hospital of the University of Chinese Academy of Sciences

    Hangzhou, Zhejiang

    Ji Zhu

    Recruiting

  • The first affiliated hospital of Zhengzhou University

    Zhengzhou, Henan

    Yanru Qin

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors

This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.

Read the detailed description

Using dose escalation, 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.

Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors.

This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study.

Being tested
PRJ1-3024
Keywords
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 groups in NCT05315167
Study groupRoleWhat they receive
Monotherapy EscalationExperimental3+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
Monotherapy Exploration of the recommended doseExperimentalUpon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 with several cohorts enrolled to confirm the tolerability of the RP2D of PRJ1-3024 (determined in Phase 1). PRJ1-3024 is administered orally once daily. The starting dose is determined by clinical effecacy data from Phase 1, and treatment may continue for up to 2 years as long as the subject experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease.
Receives: Drug: PRJ1-3024

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. Incidence of adverse events (AEs)

    Characterized by type, seriousness, relationship to study treatment, timing, and severity.

    Measured: 24 months

  2. 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

  3. 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

  4. 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

  5. Pharmacokinetic parameter#AUC0-last#

    Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration

    Measured: 24 months

  6. 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.

  1. First posted7 Apr 2022
  2. Study start30 May 2022
  3. Primary completion15 May 2027 (estimated)
  4. Study completion15 Nov 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Model description
Part 1 is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024. Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 to confirm the tolerability and efficacy of the RP2D of PRJ1-3024 .
Masking
None (open label)
Enrolment
267 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05315167
Sponsor's protocol ID
PRJ1-3024-001
Other IDs
CXHL2101725
Status last verified
Oct 2024
First submitted
29 Mar 2022
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PRJ1-3024 in people with Advanced Solid Tumor and Advanced Solid Malignancies, run by Zhuhai Yufan Biotechnologies Co., Ltd at 5 sites 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: looking for participants now, as of the sponsor's last update on 17 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 5 sites 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?

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 Liting Lai (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?

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?

On the ClinicalTrials.gov record for NCT05315167.

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 17 Dec 2024.

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