PRJ1-3024 for Cancer

Not currently recruiting at 5 trial locations

Overseen By Yang Xu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd

Must not be taking: Strong CYP3A inhibitors

Disqualifiers: Other malignancy, Brain metastases, Cardiovascular, HBV, HCV, AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and initial effectiveness of a new treatment called PRJ1-3024 for people with solid tumors that have returned or don't respond to usual treatments. Participants take the medication orally each day, starting at a low dose, to assess tolerance. The study seeks individuals with advanced or spreading solid tumors who haven't found other treatments effective or suitable. Participants must be able to take daily medication and have a life expectancy of more than three months. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that you stop taking any current anti-cancer therapy or investigational products. It also excludes those taking strong inhibitors or inducers of a specific enzyme (CYP3A).

Is there any evidence suggesting that PRJ1-3024 is likely to be safe for humans?

Research has shown that PRJ1-3024 is generally safe for patients with advanced solid tumors. In a study with Chinese patients, the treatment proved safe, and researchers continue to study its effects. This trial is in its early stages, focusing primarily on safety. The treatment aims to boost the body's immune response against tumors. So far, PRJ1-3024 has not presented major safety issues, but researchers are still determining the optimal dose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PRJ1-3024 is unique because it is designed to be taken orally once a day, which can be more convenient and less invasive than many current cancer treatments that require intravenous administration. Unlike traditional chemotherapy, which often attacks both cancerous and healthy cells, PRJ1-3024 is expected to selectively target cancer cells, potentially reducing side effects. Researchers are excited about its novel dosing strategy, starting with a low dose and carefully increasing, which aims to maximize effectiveness while minimizing risk.

What evidence suggests that PRJ1-3024 might be an effective treatment for cancer?

Research has shown that PRJ1-3024 could be a promising treatment for solid tumors. It blocks HPK1, an enzyme that aids cancer growth. Studies have found that PRJ1-3024 is generally safe, with few serious side effects reported. While detailed efficacy results are still pending, early findings suggest it might influence tumor activity. In this trial, participants will receive PRJ1-3024 in a monotherapy escalation arm to determine the optimal dose and assess its initial effects on tumors. ^{1 3 4 5 6}

Who Is on the Research Team?

Yang Xu, PhD

Principal Investigator

Head of US Clinical Development

Are You a Good Fit for This Trial?

Adults (≥18 years) with advanced solid tumors that are untreatable by standard therapies or when such treatments aren't suitable. Participants must have a measurable tumor, be able to take oral meds and track their use, have a life expectancy over 3 months, and proper organ function. They should not have other cancers, significant heart disease, active hepatitis or HIV infections, recent live vaccines, autoimmune diseases on immunosuppressants, or current cancer treatments.

Inclusion Criteria

My kidney and liver are functioning well.

I can take care of myself and am up and about more than half of my waking hours.

My advanced cancer has no standard treatment options left.

Exclusion Criteria

I am not taking any cancer treatments, trial drugs, or specific enzyme inhibitors.

I need more than 10 mg/day of prednisolone for my brain metastases.

I have a serious heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

3+3 dose escalation study to determine the maximum tolerated dose of PRJ1-3024

3 weeks

Daily visits for dose administration and monitoring

Treatment

Participants receive PRJ1-3024 orally once daily to evaluate safety, tolerability, and efficacy

24 months

Regular visits for safety and pharmacokinetic assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PRJ1-3024

Trial Overview

The trial is testing PRJ1-3024's safety and early effectiveness in patients with relapsed/refractory solid tumors. It's an open-label study where everyone gets the drug; doses increase until they find the highest dose patients can safely take without severe side effects ('dose escalation').

How Is the Trial Designed?

Group I: Monotherapy Escalation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Zhuhai Yufan Biotechnologies Co., Ltd

Lead Sponsor

Trials

3

Recruited

350+

Published Research Related to This Trial

In a phase I trial involving 28 men with androgen-independent prostate cancer, the combination of imatinib and docetaxel showed a maximum-tolerated dose of docetaxel at 30 mg/m², with notable side effects including fatigue and nausea.

The treatment led to significant declines in prostate-specific antigen (PSA) levels, with 38% of patients experiencing a PSA decline greater than 50%, indicating potential long-term efficacy of the combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-derived growth factor receptor inhibitor imatinib mesylate and docetaxel: a modular phase I trial in androgen-independent prostate cancer. Mathew, P., Thall, PF., Jones, D., et al.[2018]

Aflibercept combined with FOLFIRI significantly improved overall survival in patients with metastatic colorectal cancer (mCRC) previously treated with oxaliplatin, showing median survival of 12.5 months compared to 11.7 months with placebo.

The treatment effect of aflibercept was consistent across various patient subgroups, including those with or without prior bevacizumab treatment, indicating its broad efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Tabernero, J., Van Cutsem, E., Lakomý, R., et al.[2022]

Aflibercept, when combined with FOLFIRI, significantly improved progression-free survival (6.90 months vs. 4.67 months) and overall survival (13.50 months vs. 12.06 months) in patients with metastatic colorectal cancer who had previously undergone oxaliplatin treatment, although it was associated with more severe adverse events.

In contrast, aflibercept did not enhance progression-free survival or response rates when added to the mFOLFOX6 regimen in first-line treatment, highlighting the need for further research to optimize its use with other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept. Ciombor, KK., Berlin, J., Chan, E.[2021]

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2590

A phase I/II study to evaluate the safety, pharmacokinetics ...

Conclusions: PRJ1-3024 is shown to be well tolerated in Chinese advanced solid tumor patients. Further safety and efficacy results would be ...

2.

jitc.bmj.com

jitc.bmj.com/content/11/Suppl_1/A1182

1073 A phase 1, first-in-human, open-label study ...

Conclusions PRJ1–3024 is a potent inhibitor of HPK1 that is shown to be well tolerated. Further safety and efficacy results will be presented at ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06727630

A Phase Ib Study of PRJ1-3024 for Treatment of Advanced ...

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRJ1-3024 and will determine the recommended dose in China subjects ...

4.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/338872

A Phase I/II Study to Evaluate the Safety, Pharmacokinetics ...

PRJ1-3024 is administered orally once daily. The starting dose is determined by clinical effecacy data from Phase 1, and treatment may continue ...

5.

trialx.com

trialx.com/clinical-trials/listings/274139/a-phase-iii-study-to-evaluate-the-safety-pharmacokinetics-and-efficacy-of-prj1-3024-in-subjects-with-advanced-solid-tumors/

A Phase I/II Study to Evaluate the Safety, Pharmacokinetics ...

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 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05315167

NCT05315167 | A Phase I/II Study to Evaluate the Safety, ...

Using dose escalation, the study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in ...