What side effects are associated with this type of intervention?

Common treatments for relapsed/refractory solid tumors, such as chemotherapy, immunotherapy, and targeted therapies, often have significant side effects. Chemotherapy can cause hematologic toxicities like neutropenia, anemia, and thrombocytopenia, as well as non-hematologic effects such as fatigue, nausea, vomiting, and diarrhea. Immunotherapies, including checkpoint inhibitors like nivolumab and pembrolizumab, may lead to immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. Targeted therapies, such as tyrosine kinase inhibitors, can result in hypertension, hand-foot syndrome, and liver toxicity. These side effects vary in severity and frequency, necessitating careful patient monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for relapsed or refractory solid tumors, including immune checkpoint inhibitors like pembrolizumab and nivolumab, which target the PD-1/PD-L1 pathway. Additionally, targeted therapies such as lenvatinib, often used in combination with pembrolizumab, have shown efficacy in advanced endometrial cancer. Other notable approvals include bevacizumab for use in combination with chemotherapy in certain types of solid tumors, and olaparib for patients with homologous recombination repair deficiencies. These treatments focus on enhancing the immune response or targeting specific genetic mutations within the tumors.

What other types of research exist?

Promising novel alternatives to PRJ1-3024 for solid tumors include: 1) Pembrolizumab plus chemotherapy, as shown in the KEYNOTE-189 trial for non-small cell lung cancer, demonstrating improved survival rates. 2) Niraparib combined with abiraterone for prostate cancer with homologous recombination repair deficiency, as evidenced by the MAGNITUDE trial. 3) Nivolumab plus relatlimab for metastatic melanoma, which has shown efficacy in phase I/II trials. 4) Bevacizumab combined with everolimus for recurrent meningioma, as indicated by phase II trial results. These alternatives have demonstrated safety and preliminary efficacy in their respective studies.

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PRJ1-3024 for Cancer

Phase 1

Recruiting

Research Sponsored by Zhuhai Yufan Biotechnologies Co., Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

ECOG Performance Status 0~2

Must not have

Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A)

Known symptomatic brain metastases requiring >10 mg/day of prednisolone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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').

What are the potential side effects?

Specific side effects of PRJ1-3024 aren't listed but may include typical reactions to cancer drugs like nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems. Organ inflammation and allergic reactions could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced cancer has no standard treatment options left.

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

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I can take pills and am willing to track my medication use daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a serious heart condition.

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I have not received a live vaccine in the last 30 days.

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I have had another type of cancer in the past.

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I have an active autoimmune disorder or am on immunosuppressive therapy.

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I have not been treated with HPK1 inhibitors before.

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I do not have active hepatitis B, hepatitis C, or AIDS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period

Secondary study objectives

Duration of response (DOR)

Incidence of adverse events (AEs)

Objective response rate (ORR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Monotherapy EscalationExperimental Treatment1 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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapy involves drugs designed to specifically target molecular pathways critical for tumor growth and survival, such as tyrosine kinase inhibitors that block signals needed for tumors to grow. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells, using agents like checkpoint inhibitors to enhance immune response. These mechanisms are crucial for solid tumor patients, especially those with relapsed or refractory disease, as they offer different strategies to control tumor growth, manage symptoms, and potentially improve survival outcomes.