PRJ1-3024 for Cancer

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

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medicine, PRJ1-3024, on patients with advanced solid tumors that have not responded to other treatments. The study aims to find a safe dose and see if the medicine can shrink or stop tumor growth.

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).

What safety data exists for the treatment PRJ1-3024 or similar CXCR4 antagonists?

The safety of CXCR4 antagonists, which may include treatments like PRJ1-3024, has been evaluated in mouse models. These models showed that mice with human-like CXCR4 were healthy and reproduced normally, suggesting a level of safety in these animals. However, detailed human safety data would typically be assessed in later stages of clinical trials. ^{1 2 3 4 5}

How does the drug PRJ1-3024 differ from other cancer treatments?

The drug PRJ1-3024 may be unique in its mechanism of action, potentially involving the inhibition of the CXCR4 receptor, which is known to play a role in cancer cell growth and metastasis. This approach could offer a novel way to target cancer cells compared to traditional treatments. ^{2 6 7 8 9}

What data supports the effectiveness of the drug PRJ1-3024 for cancer?

Aflibercept, a component similar to PRJ1-3024, has shown effectiveness in improving survival in patients with metastatic colorectal cancer when combined with other chemotherapy drugs, as seen in the VELOUR trial. ^{10 11 12 13 14}

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

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Aflibercept. [2021]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A randomized controlled, open-label early phase II trial comparing incidence of FOLFIRI.3-induced diarrhoea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Exploration of potential prognostic biomarkers in aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Multicenter phase II study of FOLFOX for metastatic colorectal cancer (mCRC) in Japan; SWIFT-1 and 2 study. [2013]

6. England pubmed.ncbi.nlm.nih.gov

SEMA3F prevents metastasis of colorectal cancer by PI3K-AKT-dependent down-regulation of the ASCL2-CXCR4 axis. [2022]

7. Greece pubmed.ncbi.nlm.nih.gov

Expression and potential role of chemokine receptor CXCR4 in human bladder carcinoma cell lines with different metastatic ability. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Discovery of Tetrahydroisoquinoline-Containing CXCR4 Antagonists with Improved in Vitro ADMET Properties. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

In vitro and in vivo therapeutic efficacy of CXCR4 antagonist BKT140 against human non-small cell lung cancer. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

A mouse model for evaluation of efficacy and concomitant toxicity of anti-human CXCR4 therapeutics. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Phase I and pharmacologic study of the tyrosine kinase inhibitor SU101 in patients with advanced solid tumors. [2018]

12. China pubmed.ncbi.nlm.nih.gov

[Some research progress of CXCR4 antagonist AMD3100]. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

A multi-institutional phase ii study of SU101, a platelet-derived growth factor receptor inhibitor, for patients with hormone-refractory prostate cancer. [2018]

14. United States 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. [2018]